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Trial record 31 of 34 for:    myopic macular degeneration

Observational Study Of The Long-Term Effect Of Macugen In Patients With Wet Age-Related Macular Degeneration (MACULA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01245387
Recruitment Status : Completed
First Posted : November 22, 2010
Results First Posted : January 7, 2011
Last Update Posted : January 13, 2011
Sponsor:
Information provided by:
Pfizer

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Conditions Macular Degeneration
Age-related Macular Degeneration
Neovascular Macular Degeneration
Intervention Drug: Pegaptanib
Enrollment 1001
Recruitment Details  
Pre-assignment Details This observational study did not define endpoints as primary or secondary. All endpoints arbitrarily assigned as primary for reporting results.
Arm/Group Title Macugen
Hide Arm/Group Description Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
Period Title: Overall Study
Started 1001
Completed 188
Not Completed 813
Reason Not Completed
Lost to Follow-up             106
Lack of Efficacy             195
Adverse Event             9
Death             3
Other             131
Missing discontinuation status             369
Arm/Group Title Macugen
Hide Arm/Group Description Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
Overall Number of Baseline Participants 1001
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1001 participants
77.4  (7.8)
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1001 participants
Female 666
Male 330
Unspecified 5
1.Primary Outcome
Title Visual Acuity (VA)
Hide Description VA measured at each follow-up visit as the number of lines read on a standard eye chart (Snellen or Early Treatment Diabetic Retinopathy Study [EDTRS]) using a 5 meter distance, 1 meter distance, or verifying if participant was able to count fingers, perceive hand motion, or light. Follow-up visits occurred only if considered part of standard medical treatment. The timeframe was as follows: Visit 1: before first injection; Visit 2: first injection; Visit 3: 6 weeks after first injection (second injection).
Time Frame Baseline, every 6 weeks up to Month 24 or early termination
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS):participants who received at least 1 Macugen (pegaptanib) injection and had at least 1 VA measurement postbaseline. Participants with light perception or no light perception any time during study were excluded from FAS; N=participants with evaluable data; Last Visit: last available postbaseline value.
Arm/Group Title Macugen
Hide Arm/Group Description:
Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
Overall Number of Participants Analyzed 812
Mean (Standard Deviation)
Unit of Measure: lines of VA
Visit 1, Baseline (N=812) 8.51  (5.03)
Visit 2, Week 0, first injection (N=812) 8.72  (5.19)
Visit 3, Week 6 (N=785) 8.67  (4.90)
Visit 4, Week 12 (N=684) 8.93  (4.97)
Visit 5, Week 18 (N=537) 9.06  (4.81)
Visit 6, Week 24 (N=253) 8.83  (5.32)
Visit 7, Week 30 (N=203) 8.60  (4.69)
Visit 8, Week 36 (N=133) 8.07  (3.81)
Visit 9, Week 42 (N=86) 8.35  (3.42)
Visit 10, Week 48 (N=54) 8.33  (3.44)
Visit 11, Week 54 (N=11) 8.86  (3.30)
Visit 12, Week 60 (N=6) 9.34  (3.33)
Visit 13, Week 66 (N=4) 8.49  (3.01)
Visit 14, Week 72 (N=2) 7.61  (3.37)
Last Visit (N=786) 9.26  (5.24)
2.Primary Outcome
Title Vision-related Functioning and Quality of Life Using the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25): Overall Composite Score
Hide Description Participant-reported vision-related functioning and quality of life measured using the 25 item NEI-VFQ-25. Converted scale 0-100 where higher score represented better functioning: General Health: item 1; General Vision: item 2; Ocular Pain: 4,19; Near Vision: 5,6,7; Distance Vision: 8,9,14; Social Functioning: 11,13; Mental Health Activities: 3,21,22,25; Role Difficulties: 17,18; Dependency: 20,23,24; Driving: 15c,16, 16a; Color Vision: 12; Peripheral Vision: 10.
Time Frame Baseline, every 6 months up to Month 24 or early termination
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; N=number of participants with evaluable data; Last Visit: last available postbaseline value.
Arm/Group Title Macugen
Hide Arm/Group Description:
Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
Overall Number of Participants Analyzed 485
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Visit 1, Baseline (N=485) 54.05  (23.50)
Visit 2, Month 6 (N=219) 55.56  (22.17)
Visit 3, Month 12 (N=167) 57.13  (21.60)
Visit 4, Month 18 (N=135) 56.95  (20.58)
Visit 5, Month 24 (N=338) 56.09  (23.73)
Last Visit (N=410) 54.90  (23.86)
3.Primary Outcome
Title Number of Participants With Investigator Assessments of Efficacy
Hide Description Investigator's categorical assessment of the efficacy of Macugen (pegaptanib) treatment at the final visit or termination of therapy; Categories included Very Good, Good, Moderate, and Poor.
Time Frame Month 24 or early termination
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; N = number of participants with evaluable data.
Arm/Group Title Macugen
Hide Arm/Group Description:
Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
Overall Number of Participants Analyzed 604
Measure Type: Number
Unit of Measure: Participants
Very Good 36
Good 226
Moderate 168
Poor 174
4.Primary Outcome
Title Lesion Size (Number of Optic Disc Areas)
Hide Description Lesion size measured by Investigator after each injection as part of standard of care (SOC), using standard clinical methods practiced (fluorescein or indocyanine green angiography); Reported as the number of optic-disk areas, each of which were 2.54 millimeters squared (mm^2). Lesion size included choroidal neovascularization, exudation area, and hemorrhage, if present. The timeframe was as follows: Visit 1: before first injection; Visit 3: 6 weeks after first injection (second injection).
Time Frame Baseline, every 6 weeks up to Month 24 or early termination
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; N=number of participants with evaluable data; Last Visit: last available postbaseline value.
Arm/Group Title Macugen
Hide Arm/Group Description:
Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
Overall Number of Participants Analyzed 712
Mean (Standard Deviation)
Unit of Measure: number of optic disc areas
Visit 1, Baseline (N=712) 2.4  (1.6)
Visit 3, Week 6 (N=190) 2.1  (1.2)
Visit 4, Week 12 (N=173) 2.3  (1.7)
Visit 5, Week 18 (N=316) 2.2  (2.0)
Visit 6, Week 24 (N=45) 2.3  (1.3)
Visit 7, Week 30 (N=45) 3.2  (2.1)
Visit 8, Week 36 (N=78) 2.8  (2.0)
Visit 9, Week 42 (N=15) 2.5  (1.3)
Visit 10, Week 48 (N=9) 2.5  (1.4)
Visit 11, Week 54 (N=6) 2.3  (0.8)
Visit 12, Week 60 (N=2) 2.0  (1.4)
Visit 13, Week 66 (N=3) 0.8  (0.3)
Last Visit (N=513) 2.5  (2.1)
5.Primary Outcome
Title Number of Participants With a Change in Activity of Neovascular Membrane at Week 6
Hide Description Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 3, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.
Time Frame Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; N=number of participants with evaluable data.
Arm/Group Title Macugen
Hide Arm/Group Description:
Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
Overall Number of Participants Analyzed 190
Measure Type: Number
Unit of Measure: Participants
Increased 28
Unchanged 74
Decreased 88
6.Primary Outcome
Title Number of Participants With a Change in Activity of Neovascular Membrane at Week 12
Hide Description Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 4, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; N=number of participants with evaluable data.
Arm/Group Title Macugen
Hide Arm/Group Description:
Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
Overall Number of Participants Analyzed 173
Measure Type: Number
Unit of Measure: Participants
Increased 22
Unchanged 66
Decreased 85
7.Primary Outcome
Title Number of Participants With a Change in Activity of Neovascular Membrane at Week 18
Hide Description Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 5, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.
Time Frame Week 18
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; N=number of participants with evaluable data.
Arm/Group Title Macugen
Hide Arm/Group Description:
Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
Overall Number of Participants Analyzed 316
Measure Type: Number
Unit of Measure: Participants
Increased 57
Unchanged 83
Decreased 176
8.Primary Outcome
Title Number of Participants With a Change in Activity of Neovascular Membrane at Week 24
Hide Description Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 6, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; N=number of participants with evaluable data.
Arm/Group Title Macugen
Hide Arm/Group Description:
Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
Overall Number of Participants Analyzed 46
Measure Type: Number
Unit of Measure: Participants
Increased 13
Unchanged 15
Decreased 18
9.Primary Outcome
Title Number of Participants With a Change in Activity of Neovascular Membrane at Week 30
Hide Description Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 7, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.
Time Frame Week 30
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; N=number of participants with evaluable data.
Arm/Group Title Macugen
Hide Arm/Group Description:
Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
Overall Number of Participants Analyzed 45
Measure Type: Number
Unit of Measure: Participants
Increased 6
Unchanged 15
Decreased 24
10.Primary Outcome
Title Number of Participants With a Change in Activity of Neovascular Membrane at Week 36
Hide Description Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 8, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.
Time Frame Week 36
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; N=number of participants with evaluable data.
Arm/Group Title Macugen
Hide Arm/Group Description:
Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
Overall Number of Participants Analyzed 78
Measure Type: Number
Unit of Measure: Participants
Increased 11
Unchanged 21
Decreased 46
11.Primary Outcome
Title Number of Participants With a Change in Activity of Neovascular Membrane at Week 42
Hide Description Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 9, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.
Time Frame Week 42
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; N=number of participants with evaluable data.
Arm/Group Title Macugen
Hide Arm/Group Description:
Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
Overall Number of Participants Analyzed 15
Measure Type: Number
Unit of Measure: Participants
Increased 3
Unchanged 6
Decreased 6
12.Primary Outcome
Title Number of Participants With a Change in Activity of Neovascular Membrane at Week 48
Hide Description Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 10, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; N=number of participants with evaluable data.
Arm/Group Title Macugen
Hide Arm/Group Description:
Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: Participants
Increased 2
Unchanged 3
Decreased 5
13.Primary Outcome
Title Number of Participants With a Change in Activity of Neovascular Membrane at Week 54
Hide Description Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 11, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.
Time Frame Week 54
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; N=number of participants with evaluable data.
Arm/Group Title Macugen
Hide Arm/Group Description:
Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
Overall Number of Participants Analyzed 6
Measure Type: Number
Unit of Measure: Participants
Increased 0
Unchanged 2
Decreased 4
14.Primary Outcome
Title Number of Participants With a Change in Activity of Neovascular Membrane at Week 60
Hide Description Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 12, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.
Time Frame Week 60
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; N=number of participants with evaluable data.
Arm/Group Title Macugen
Hide Arm/Group Description:
Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
Overall Number of Participants Analyzed 2
Measure Type: Number
Unit of Measure: Participants
Increased 1
Unchanged 0
Decreased 1
15.Primary Outcome
Title Number of Participants With a Change in Activity of Neovascular Membrane at Week 66
Hide Description Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 13, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.
Time Frame Week 66
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; N=number of participants with evaluable data.
Arm/Group Title Macugen
Hide Arm/Group Description:
Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
Overall Number of Participants Analyzed 3
Measure Type: Number
Unit of Measure: Participants
Increased 0
Unchanged 1
Decreased 2
16.Primary Outcome
Title Number of Participants With a Change in Activity of Neovascular Membrane at Week 72
Hide Description Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 14, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.
Time Frame Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; N=number of participants with evaluable data.
Arm/Group Title Macugen
Hide Arm/Group Description:
Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: Participants
Increased 0
Unchanged 0
Decreased 1
17.Primary Outcome
Title Number of Participants With a Change in Activity of Neovascular Membrane at Last Visit
Hide Description Neovascular membrane activity (measured by leakage) assessed by Investigator at the Last Visit, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity. Last Visit: last available postbaseline value.
Time Frame Month 24 or early termination
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; N=number of participants with evaluable data.
Arm/Group Title Macugen
Hide Arm/Group Description:
Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
Overall Number of Participants Analyzed 514
Measure Type: Number
Unit of Measure: Participants
Increased 101
Unchanged 170
Decreased 243
18.Primary Outcome
Title Number of Participants With Pigment Epithelial Detachment (PED) at Baseline
Hide Description PED assessed by Investigator at baseline as part of SOC for participants with age-related macular degeneration; Standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; N=number of participants with evaluable data.
Arm/Group Title Macugen
Hide Arm/Group Description:
Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
Overall Number of Participants Analyzed 713
Measure Type: Number
Unit of Measure: Participants
Present 240
Absent 473
19.Primary Outcome
Title Number of Participants With PED at Week 6
Hide Description PED assessed by Investigator at Visit 3, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.
Time Frame Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; N=number of participants with evaluable data.
Arm/Group Title Macugen
Hide Arm/Group Description:
Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
Overall Number of Participants Analyzed 188
Measure Type: Number
Unit of Measure: Participants
Present 46
Absent 142
20.Primary Outcome
Title Number of Participants With PED at Week 12
Hide Description PED assessed by Investigator at Visit 4, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; N=number of participants with evaluable data.
Arm/Group Title Macugen
Hide Arm/Group Description:
Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
Overall Number of Participants Analyzed 169
Measure Type: Number
Unit of Measure: Participants
Present 32
Absent 137
21.Primary Outcome
Title Number of Participants With PED at Week 18
Hide Description PED assessed by Investigator at Visit 5, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.
Time Frame Week 18
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; N=number of participants with evaluable data.
Arm/Group Title Macugen
Hide Arm/Group Description:
Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
Overall Number of Participants Analyzed 313
Measure Type: Number
Unit of Measure: Participants
Present 45
Absent 268
22.Primary Outcome
Title Number of Participants With PED at Week 24
Hide Description PED assessed by Investigator at Visit 6, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; N=number of participants with evaluable data.
Arm/Group Title Macugen
Hide Arm/Group Description:
Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
Overall Number of Participants Analyzed 45
Measure Type: Number
Unit of Measure: Participants
Present 7
Absent 38
23.Primary Outcome
Title Number of Participants With PED at Week 30
Hide Description PED assessed by Investigator at Visit 7, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.
Time Frame Week 30
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; N=number of participants with evaluable data.
Arm/Group Title Macugen
Hide Arm/Group Description:
Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
Overall Number of Participants Analyzed 44
Measure Type: Number
Unit of Measure: Participants
Present 11
Absent 33
24.Primary Outcome
Title Number of Participants With PED at Week 36
Hide Description PED assessed by Investigator at Visit 8, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.
Time Frame Week 36
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; N=number of participants with evaluable data.
Arm/Group Title Macugen
Hide Arm/Group Description:
Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
Overall Number of Participants Analyzed 77
Measure Type: Number
Unit of Measure: Participants
Present 11
Absent 66
25.Primary Outcome
Title Number of Participants With PED at Week 42
Hide Description PED assessed by Investigator at Visit 9, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.
Time Frame Week 42
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; N=number of participants with evaluable data.
Arm/Group Title Macugen
Hide Arm/Group Description:
Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
Overall Number of Participants Analyzed 15
Measure Type: Number
Unit of Measure: Participants
Present 3
Absent 12
26.Primary Outcome
Title Number of Participants With PED at Week 48
Hide Description PED assessed by Investigator at Visit 10, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; N=number of participants with evaluable data.
Arm/Group Title Macugen
Hide Arm/Group Description:
Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: Participants
Present 6
Absent 4
27.Primary Outcome
Title Number of Participants With PED at Week 54
Hide Description PED assessed by Investigator Visit 11, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.
Time Frame Week 54
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; N=number of participants with evaluable data.
Arm/Group Title Macugen
Hide Arm/Group Description:
Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
Overall Number of Participants Analyzed 6
Measure Type: Number
Unit of Measure: Participants
Present 1
Absent 5
28.Primary Outcome
Title Number of Participants With PED at Last Visit
Hide Description PED assessed by Investigator at Last Visit, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent. Last Visit: last available postbaseline value.
Time Frame Month 24 or early termination
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; N=number of participants with evaluable data.
Arm/Group Title Macugen
Hide Arm/Group Description:
Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
Overall Number of Participants Analyzed 509
Measure Type: Number
Unit of Measure: Participants
Present 87
Absent 422
29.Primary Outcome
Title Central Retinal Thickness
Hide Description Central retinal thickness assessed by Investigator every 6 weeks, as part of SOC, using standard clinical methods practiced (optical coherence tomography) and reported as mean central retinal thickness. The timeframe was as follows: Visit 1: before first injection; Visit 3: 6 weeks after first injection (second injection).
Time Frame Baseline, every 6 weeks up to Month 24 or early termination
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; N=number of participants with evaluable data; Last Visit: last available postbaseline value.
Arm/Group Title Macugen
Hide Arm/Group Description:
Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
Overall Number of Participants Analyzed 316
Mean (Standard Deviation)
Unit of Measure: Micrometers (Mcm)
Visit 1, Baseline (N=316) 309.2  (105.9)
Visit 3, Week 6 (N=224) 305.8  (111.3)
Visit 4, Week 12 (N=173) 307.3  (122.9)
Visit 5, Week 18 (N=205) 297.8  (145.0)
Visit 6, Week 24 (N=33) 328.9  (180.5)
Visit 7, Week 30 (N=26) 272.7  (67.4)
Visit 8, Week 36 (N=27) 319.6  (118.7)
Visit 9, Week 42 (N=13) 252.9  (88.8)
Visit 10, Week 48 (N=3) 312.0  (133.5)
Last Visit (N=311) 295.2  (138.5)
30.Primary Outcome
Title Number of Participants With Angiographic Subtype Reported at Baseline
Hide Description Angiographic subtype assessed by Investigator at Baseline, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the percent [%] classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; N=number of participants with evaluable data.
Arm/Group Title Macugen
Hide Arm/Group Description:
Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
Overall Number of Participants Analyzed 716
Measure Type: Number
Unit of Measure: Participants
unclear 76
occult 363
minimally classic 113
predominantly classic 138
pure classic 26
31.Primary Outcome
Title Number of Participants With Angiographic Subtype Reported at Week 6
Hide Description Angiographic subtype assessed by Investigator at Visit 3, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the percent [%] classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).
Time Frame Week 6
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FAS;N=number of participants with evaluable data.
Arm/Group Title Macugen
Hide Arm/Group Description:
Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
Overall Number of Participants Analyzed 190
Measure Type: Number
Unit of Measure: Participants
unclear 29
occult 81
minimally classic 21
predominantly classic 56
pure classic 3
32.Primary Outcome
Title Number of Participants With Angiographic Subtype Reported at Week 12
Hide Description Angiographic subtype assessed by Investigator at Visit 4, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the percent [%] classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).
Time Frame Week 12
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Hide Analysis Population Description
FAS; N=number of participants with evaluable data.
Arm/Group Title Macugen
Hide Arm/Group Description:
Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
Overall Number of Participants Analyzed 173
Measure Type: Number
Unit of Measure: Participants
unclear 29
occult 71
minimally classic 21
predominantly classic 50
pure classic 2
33.Primary Outcome
Title Number of Participants With Angiographic Subtype Reported at Week 18
Hide Description Angiographic subtype assessed by Investigator at Visit 5, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the percent [%] classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).
Time Frame Week 18
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Hide Analysis Population Description
FAS; N=number of participants with evaluable data.
Arm/Group Title Macugen
Hide Arm/Group Description:
Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
Overall Number of Participants Analyzed 316
Measure Type: Number
Unit of Measure: Participants
unclear 68
occult 140
minimally classic 70
predominantly classic 30
pure classic 8
34.Primary Outcome
Title Number of Participants With Angiographic Subtype Reported at Week 24
Hide Description Angiographic subtype assessed by Investigator at Visit 6, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the percent [%] classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).
Time Frame Week 24
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Hide Analysis Population Description
FAS; N=number of participants with evaluable data.
Arm/Group Title Macugen
Hide Arm/Group Description:
Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
Overall Number of Participants Analyzed 45
Measure Type: Number
Unit of Measure: Participants
unclear 7
occult 26
minimally classic 5
predominantly classic 5
pure classic 2
35.Primary Outcome
Title Number of Participants With Angiographic Subtype Reported at Week 30
Hide Description Angiographic subtype assessed by Investigator at Visit 7, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the percent (%) classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).
Time Frame Week 30
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; N=number of participants with evaluable data.
Arm/Group Title Macugen
Hide Arm/Group Description:
Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
Overall Number of Participants Analyzed 45
Measure Type: Number
Unit of Measure: Participants
unclear 10
occult 23
minimally classic 8
predominantly classic 3
pure classic 1
36.Primary Outcome
Title Number of Participants With Angiographic Subtype Reported at Week 36
Hide Description Angiographic subtype assessed by Investigator at Visit 8, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the % classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).
Time Frame Week 36
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; N=number of participants with evaluable data.
Arm/Group Title Macugen
Hide Arm/Group Description:
Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
Overall Number of Participants Analyzed 78
Measure Type: Number
Unit of Measure: Participants
unclear 5
occult 37
minimally classic 30
predominantly classic 3
pure classic 3
37.Primary Outcome
Title Number of Participants With Angiographic Subtype Reported at Week 42
Hide Description Angiographic subtype assessed by Investigator at Visit 9, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the % classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).
Time Frame Week 42
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; N=number of participants with evaluable data.
Arm/Group Title Macugen
Hide Arm/Group Description:
Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
Overall Number of Participants Analyzed 15
Measure Type: Number
Unit of Measure: Participants
unclear 3
occult 10
minimally classic 1
predominantly classic 0
pure classic 1
38.Primary Outcome
Title Number of Participants With Angiographic Subtype Reported at Week 48
Hide Description Angiographic subtype assessed by Investigator at Visit 10, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the % classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; N=number of participants with evaluable data.
Arm/Group Title Macugen
Hide Arm/Group Description:
Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: Participants
unclear 0
occult 7
minimally classic 3
predominantly classic 0
pure classic 0
39.Primary Outcome
Title Number of Participants With Angiographic Subtype Reported at Week 54
Hide Description Angiographic subtype assessed by Investigator at Visit 11, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the % classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).
Time Frame Week 54
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; N=number of participants with evaluable data.
Arm/Group Title Macugen
Hide Arm/Group Description:
Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
Overall Number of Participants Analyzed 6
Measure Type: Number
Unit of Measure: Participants
unclear 0
occult 3
minimally classic 3
predominantly classic 0
pure classic 0
40.Primary Outcome
Title Number of Participants With Angiographic Subtype Reported at Last Visit
Hide Description Angiographic subtype assessed by Investigator at the Last Visit, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the % classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic). Last Visit: last available postbaseline value.
Time Frame Month 24 or early termination
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; N=number of participants with evaluable data.
Arm/Group Title Macugen
Hide Arm/Group Description:
Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
Overall Number of Participants Analyzed 514
Measure Type: Number
Unit of Measure: Participants
unclear 105
occult 251
minimally classic 88
predominantly classic 58
pure classic 12
41.Other Pre-specified Outcome
Title Time to First Adverse Event (AE)
Hide Description Time to first AE during the study evaluated by Kaplan-Meier Product-limit methods. AE:any untoward medical occurrence in a participant administered a product or medical device in the context of study; the event need not necessarily have a causal relationship with the treatment or usage.
Time Frame Baseline up to Month 24 or early termination
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Hide Analysis Population Description
Safety Set: all participants who received at least 1 Macugen (pegaptanib) injection and provided data post baseline. Data not analyzed due to low number of AEs.
Arm/Group Title Macugen
Hide Arm/Group Description:
Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
42.Other Pre-specified Outcome
Title Number of Participants With Complications Associated With Injection
Hide Description Complications associated with injection during the study with onset at or after date of first injection was recorded by the Investigator.
Time Frame Baseline up to Month 24 or early termination
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set; N=number of participants with evaluable data.
Arm/Group Title Macugen
Hide Arm/Group Description:
Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
Overall Number of Participants Analyzed 815
Measure Type: Number
Unit of Measure: Participants
Yes 1
No 814
43.Other Pre-specified Outcome
Title Treatment Tolerability
Hide Description Investigator's overall evaluation of tolerability; Categories included: Very Good, Good, Moderate, and Poor.
Time Frame Month 24 or early termination
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set; N=number of participants with evaluable data.
Arm/Group Title Macugen
Hide Arm/Group Description:
Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
Overall Number of Participants Analyzed 589
Measure Type: Number
Unit of Measure: Participants
Very Good 182
Good 367
Moderate 35
Poor 5
44.Other Pre-specified Outcome
Title Intraocular Pressure (IOP)
Hide Description IOP measured at each visit using either applanation tonometry or non-contact before intraviterial injection, reported as pre-dose pressure of treated eye in millimeters of mercury (mmHg). The timeframe was as follows: Visit 1: IOP before any injection; Visit 2: IOP before first injection; Visit 3: IOP before second injection.
Time Frame Baseline, every 6 weeks up to Month 24 or early termination
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set; N=number of participants with evaluable data; Last Visit: last available postbaseline value.
Arm/Group Title Macugen
Hide Arm/Group Description:
Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
Overall Number of Participants Analyzed 809
Mean (Standard Deviation)
Unit of Measure: mmHg
Visit 1, Baseline (N=809) 15.7  (2.8)
Visit 2, Week 0 (N=568) 15.7  (3.0)
Visit 3, Week 6 (N=772) 15.7  (3.2)
Visit 4, Week 12 (N=661) 15.8  (3.1)
Visit 5, Week 18 (N=505) 15.9  (3.1)
Visit 6, Week 24 (N=237) 15.5  (2.8)
Visit 7, Week 30 (N=190) 15.5  (2.6)
Visit 8, Week 36 (N=123) 15.8  (2.3)
Visit 9, Week 42 (N=80) 15.4  (2.0)
Visit 10, Week 48 (N=53) 15.7  (2.3)
Visit 11, Week 54 (N=11) 16.3  (2.9)
Visit 12, Week 60 (N=6) 15.3  (4.0)
Visit 13, Week 66 (N=4) 18.0  (2.3)
Visit 14, Week 72 (N=2) 17.0  (1.4)
Last Visit (N=776) 15.6  (3.0)
45.Other Pre-specified Outcome
Title Change in IOP Between Predose and Postdose Assessment
Hide Description IOP measured at each visit using either applanation tonometry or non-contact before and after intraviterial injection. Change in IOP equals postdose IOP minus predose IOP.
Time Frame Baseline, every 6 weeks up to Month 24 or early termination
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set; N=number of participants with evaluable data; Last Visit: last available postbaseline value.
Arm/Group Title Macugen
Hide Arm/Group Description:
Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
Overall Number of Participants Analyzed 718
Mean (Standard Deviation)
Unit of Measure: mmHg
Visit 2, Week 0 (N=559) 1.3  (3.7)
Visit 3, Week 6 (N=704) 1.3  (4.1)
Visit 4, Week 12 (N=600) 1.3  (3.8)
Visit 5, Week 18 (N=240) 1.4  (3.7)
Visit 6, Week 24 (N=210) 1.5  (3.3)
Visit 7, Week 30 (N=158) 2.4  (4.9)
Visit 8, Week 36 (N=90) 1.8  (2.5)
Visit 9, Week 42 (N=63) 2.2  (2.8)
Visit 10, Week 48 (N=48) 2.3  (2.1)
Visit 11, Week 54 (n=7) 1.3  (1.7)
Visit 12, Week 60 (N=4) 1.3  (6.3)
Visit 13, Week 66 (N=2) -2.0  (4.2)
Last Visit (N=718) 1.4  (3.9)
46.Other Pre-specified Outcome
Title IOP Mean Difference (Within a Participant)
Hide Description Average predose minus postdose mean difference in IOP within a participant
Time Frame Baseline, every 6 weeks up to Month 24 or early termination
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set; N=number of participants with evaluable data.
Arm/Group Title Macugen
Hide Arm/Group Description:
Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
Overall Number of Participants Analyzed 763
Mean (Standard Deviation)
Unit of Measure: mmHg
1.3  (2.9)
Time Frame [Not Specified]
Adverse Event Reporting Description The Safety population (N=816) is less than total number of participants in study (1001) because some participants had a baseline visit but no injection or no data post baseline. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events.
 
Arm/Group Title Macugen
Hide Arm/Group Description Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
All-Cause Mortality
Macugen
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Macugen
Affected / at Risk (%)
Total   16/816 (1.96%) 
Cardiac disorders   
Myocardial infarction * 1  2/816 (0.25%) 
Atrial fibrillation * 1  1/816 (0.12%) 
Cardiac failure * 1  1/816 (0.12%) 
Coronary artery disease * 1  1/816 (0.12%) 
Eye disorders   
Retinal haemorrhage * 1  3/816 (0.37%) 
Choroidal neovascularisation * 1  1/816 (0.12%) 
Retinal detachment * 1  1/816 (0.12%) 
Retinal tear * 1  1/816 (0.12%) 
Gastrointestinal disorders   
Nausea * 1  1/816 (0.12%) 
Infections and infestations   
Endophthalmitis * 1  4/816 (0.49%) 
Sepsis * 1  1/816 (0.12%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Bladder cancer * 1  1/816 (0.12%) 
Renal cancer * 1  1/816 (0.12%) 
Nervous system disorders   
Cerebrovascular accident * 1  3/816 (0.37%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Macugen
Affected / at Risk (%)
Total   12/816 (1.47%) 
Eye disorders   
Visual acuity reduced * 1  6/816 (0.74%) 
Retinal haemorrhage * 1  1/816 (0.12%) 
Choroidal neovascularisation * 1  1/816 (0.12%) 
Retinal detachment * 1  1/816 (0.12%) 
Detachment of retinal pigment epithelium * 1  1/816 (0.12%) 
Glaucoma * 1  1/816 (0.12%) 
Subretinal fibrosis * 1  1/816 (0.12%) 
Vitreous haemorrhage * 1  1/816 (0.12%) 
General disorders   
Injection site reaction * 1  1/816 (0.12%) 
Infections and infestations   
Endophthalmitis * 1  1/816 (0.12%) 
Investigations   
Intraocular pressure increased * 1  2/816 (0.25%) 
Paracentesis eye * 1  1/816 (0.12%) 
Surgical and medical procedures   
Eye operation * 1  1/816 (0.12%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
Time to first AE not estimated due to insufficient number of events. Visit numbers for NEI-VFQ-25 deviated from numbering used in other analyses; it represents the sequence number of questionaries administered (Visit 1=first assessment, etc.).
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01245387     History of Changes
Other Study ID Numbers: A5751021
First Submitted: September 29, 2010
First Posted: November 22, 2010
Results First Submitted: December 21, 2010
Results First Posted: January 7, 2011
Last Update Posted: January 13, 2011