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Trial record 33 of 34 for:    myopic macular degeneration

Evaluation Of Safety And Efficacy Of 0.3 Mg/Eye Macugen In Patients With Small Age-Related Macular Degeneration Lesions

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ClinicalTrials.gov Identifier: NCT00324116
Recruitment Status : Completed
First Posted : May 10, 2006
Results First Posted : October 2, 2009
Last Update Posted : March 23, 2010
Sponsor:
Collaborator:
ITEC GROUP 3
Information provided by:
Pfizer

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Macular Degeneration
Intervention Drug: pegaptanib sodium (Macugen)
Enrollment 81
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pegaptanib Sodium
Hide Arm/Group Description All subjects received a 0.3 mg/eye pegaptanib sodium intravitreous injection every 6 weeks for 54 weeks.
Period Title: Overall Study
Started 81 [1]
Completed 49
Not Completed 32
Reason Not Completed
Adverse Event             5
Lack of Efficacy             17
Withdrawal by Subject             5
Other             5
[1]
subjects received treatment
Arm/Group Title Pegaptanib Sodium
Hide Arm/Group Description All subjects received a 0.3 mg/eye pegaptanib sodium intravitreous injection every 6 weeks for 54 weeks.
Overall Number of Baseline Participants 81
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 81 participants
76.3  (6.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 81 participants
Female
47
  58.0%
Male
34
  42.0%
1.Primary Outcome
Title Number of Responders for Visual Acuity Using Early Treatment Diabetic Retinopathy Study (ETDRS)
Hide Description Best-corrected visual acuity assessed using retroilluminated modified Ferris-Bailey ETDRS charts. When possible to measure visual acuity @ 2.0 m (≥20 letters), visual acuity score for that eye recorded as number of letters correct plus 15; otherwise, score was number of letters read correctly @ 1.0 m plus number, if any, read @ 2.0 m. If no letter was read correctly either at 2.0 or 1.0 m, then visual acuity score was recorded as 0. Responders defined as subjects having lost from baseline less than 15 letters of the best-corrected visual acuity; includes subjects with visual acuity gain.
Time Frame Baseline, 54 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) was derived from the set of all enrolled subjects who 1) were administered the study medication AND 2) had post-baseline documentation of efficacy available. In the case of missing data post-baseline, the subject was considered censored at the time of the last available data for the score.
Arm/Group Title Pegaptanib Sodium
Hide Arm/Group Description:
All subjects received a 0.3 mg/eye pegaptanib sodium intravitreous injection every 6 weeks for 54 weeks.
Overall Number of Participants Analyzed 80
Measure Type: Number
Unit of Measure: participants
Responders 40
Non-Responders 7
Censored (subjects with missing data) 33
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pegaptanib Sodium
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter percent responders
Estimated Value 85
Confidence Interval 95%
76 to 95
Estimation Comments Proportion of responders estimated by Kaplan-Meier analysis. Proportion of responders along with 95% CI calculated directly from estimate of survival distribution function. Percentage denominator = total number of subjects without missing data.
2.Secondary Outcome
Title Change From Baseline in Visual Acuity
Hide Description Best-corrected visual acuity assessed using retroilluminated modified Ferris-Bailey ETDRS charts. When possible to measure visual acuity @ 2.0 m (≥20 letters), visual acuity score for that eye recorded as number of letters correct plus 15; otherwise, score was number of letters read correctly @ 1.0 m plus number, if any, read @ 2.0 m. If no letter was read correctly either at 2.0 or 1.0 m, then visual acuity score was recorded as 0. Change: mean score at observation minus mean score at baseline.
Time Frame Baseline, 6 weeks, 12 weeks, 54 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; n=number of subjects with evaluable data.
Arm/Group Title Pegaptanib Sodium
Hide Arm/Group Description:
All subjects received a 0.3 mg/eye pegaptanib sodium intravitreous injection every 6 weeks for 54 weeks.
Overall Number of Participants Analyzed 80
Mean (Standard Deviation)
Unit of Measure: score on scale
6 weeks (n=76) -4.29  (11.11)
12 weeks (n=74) -5.86  (13.79)
54 weeks (n=49) -11.12  (17.96)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pegaptanib Sodium
Comments 6 weeks
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -4.29
Confidence Interval 95%
-6.83 to -1.75
Estimation Comments 95% CI for the change in mean value obtained from one sample t-test.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pegaptanib Sodium
Comments 12 weeks
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -5.86
Confidence Interval 95%
-9.06 to -2.67
Estimation Comments 95% CI for the change in mean value obtained from one sample t-test.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Pegaptanib Sodium
Comments 54 weeks
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -11.12
Confidence Interval 95%
-16.28 to -5.96
Estimation Comments 95% CI for the change in mean value obtained from one sample t-test.
3.Secondary Outcome
Title Number of Subjects Gaining Vision
Hide Description Subjects gaining vision: gain from baseline of more than 15 letters of visual acuity. Best-corrected visual acuity assessed using retroilluminated modified Ferris-Bailey ETDRS charts. When possible to measure visual acuity @ 2.0 m (≥20 letters), visual acuity score for that eye recorded as number of letters correct plus 15; otherwise, score was number of letters read correctly @ 1.0 m plus number, if any, read @ 2.0 m. If no letter was read correctly either at 2.0 or 1.0 m, then visual acuity score was recorded as 0.
Time Frame 54 weeks or at early termination
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Pegaptanib Sodium
Hide Arm/Group Description:
All subjects received a 0.3 mg/eye pegaptanib sodium intravitreous injection every 6 weeks for 54 weeks.
Overall Number of Participants Analyzed 80
Measure Type: Number
Unit of Measure: participant
Gained 4
Did not gain 74
Assessment Not Done 2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pegaptanib Sodium
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter percentage of subjects
Estimated Value 5.00
Confidence Interval 95%
1.61 to 11.32
Estimation Comments Proportion of subjects gaining vision was estimated on an observed case basis. Percentage denominator = total number of subjects in the FAS. 95% confidence intervals were calculated from Fleiss quadratic equations
4.Secondary Outcome
Title Number of Subjects Maintaining Vision
Hide Description Subjects maintaining vision: gain from baseline of more than 0 letters of visual acuity. Best-corrected visual acuity assessed using retroilluminated modified Ferris-Bailey ETDRS charts. When possible to measure visual acuity @ 2.0 m (≥20 letters), visual acuity score for that eye recorded as number of letters correct plus 15; otherwise, score was number of letters read correctly @ 1.0 m plus number, if any, read @ 2.0 m. If no letter was read correctly either at 2.0 or 1.0 m, then visual acuity score was recorded as 0.
Time Frame 54 weeks or at early termination
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Pegaptanib Sodium
Hide Arm/Group Description:
All subjects received a 0.3 mg/eye pegaptanib sodium intravitreous injection every 6 weeks for 54 weeks.
Overall Number of Participants Analyzed 80
Measure Type: Number
Unit of Measure: participants
Maintained 18
Did not maintain 60
Not Done 2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pegaptanib Sodium
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter percentage of subjects
Estimated Value 22.50
Confidence Interval 95%
14.22 to 32.11
Estimation Comments Proportion of subjects maintaining vision was estimated on an observed case basis. Percentage denominator = total number of subjects in the FAS. 95% confidence intervals were calculated from Fleiss quadratic equations.
5.Secondary Outcome
Title Number of Subjects With Severe Visual Loss
Hide Description Subjects with severe visual loss: loss from baseline of >= 30 letters of visual acuity. Best-corrected visual acuity assessed using retroilluminated modified Ferris-Bailey ETDRS charts. When possible to measure visual acuity @ 2.0 m (≥20 letters), visual acuity score for that eye recorded as number of letters correct plus 15; otherwise, score was number of letters read correctly @ 1.0 m plus number, if any, read @ 2.0 m. If no letter was read correctly either at 2.0 or 1.0 m, then visual acuity score was recorded as 0.
Time Frame 54 weeks or at early termination
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Pegaptanib Sodium
Hide Arm/Group Description:
All subjects received a 0.3 mg/eye pegaptanib sodium intravitreous injection every 6 weeks for 54 weeks.
Overall Number of Participants Analyzed 80
Measure Type: Number
Unit of Measure: participants
Severe Loss 11
Not severe loss 67
Not Done 2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pegaptanib Sodium
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter percentage of subjects
Estimated Value 13.75
Confidence Interval 95%
7.39 to 22.24
Estimation Comments Proportion of subjects with severe visual loss was estimated on an observed case basis. Percentage denominator = total number of subjects in the FAS. 95% confidence intervals were calculated from Fleiss quadratic equations.
6.Secondary Outcome
Title Number of Subjects With a Distance Visual Acuity of > 20/200 at Baseline and Progressing to (<= 20/200)
Hide Description

Subjects with improving scores are those with > 20/200 at Baseline and progressing to =< 20/200 at Week 54.

Subjects with no change are those with > 20/200 at Baseline and remaining at > 20/200 at Week 54.

Time Frame 54 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; n=77 (number of Subjects at Baseline with >20/200 Visual Acuity)
Arm/Group Title Pegaptanib Sodium
Hide Arm/Group Description:
All subjects received a 0.3 mg/eye pegaptanib sodium intravitreous injection every 6 weeks for 54 weeks.
Overall Number of Participants Analyzed 80
Measure Type: Number
Unit of Measure: participants
Improved 20
No Change 57
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pegaptanib Sodium
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter percentage of subjects
Estimated Value 25.97
Confidence Interval 95%
16.28 to 34.81
Estimation Comments Proportion of subjects progressing to <=20/200 was estimated on an observed case basis. Percentage denominator = total number of subjects in the FAS. 95% confidence intervals were calculated from Fleiss quadratic equations.
7.Secondary Outcome
Title Change in Vision-related Functioning and Quality of Life Using the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ 25).
Hide Description Patient reported vision-related functioning and quality of life as measured using the 25 item NEI-VFQ 25. Change = Mean score at 54 weeks - mean score at baseline. A positive change represents an increase in function/health from Baseline. Items grouped as the following - Composite: mean score items 1-25; 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, 54 weeks or at early termination
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; n=number of subjects with evaluable data.
Arm/Group Title Pegaptanib Sodium
Hide Arm/Group Description:
All subjects received a 0.3 mg/eye pegaptanib sodium intravitreous injection every 6 weeks for 54 weeks.
Overall Number of Participants Analyzed 80
Mean (Standard Deviation)
Unit of Measure: score on scale
Composite (n=25) -2.25  (15.71)
General Health (n=42) -4.17  (14.52)
General Vision (n=41) 3.90  (16.26)
Ocular Pain (n=43) 0.35  (15.29)
Near Vision Activities (n=43) -3.88  (27.60)
Distance Vision Activities (n=43) -6.78  (23.68)
Social Functioning (n=43) -0.58  (24.84)
Mental Health Activities (n=43) -0.30  (20.45)
Role Difficulties (n=41) -4.39  (26.46)
Dependency (n=41) -5.28  (22.15)
Driving (n=27) -3.70  (30.67)
Color Vision (n=41) -1.83  (18.87)
Peripheral Vision (n=42) -4.17  (25.25)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pegaptanib Sodium
Hide Arm/Group Description All subjects received a 0.3 mg/eye pegaptanib sodium intravitreous injection every 6 weeks for 54 weeks.
All-Cause Mortality
Pegaptanib Sodium
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Pegaptanib Sodium
Affected / at Risk (%)
Total   8 
Cardiac disorders   
Cardiac failure  1  1/81 (1.23%) 
Cardiac failure acute  1  1/81 (1.23%) 
Angina unstable  1  1/81 (1.23%) 
Eye disorders   
Cataract operation  1  1/81 (1.23%) 
Macular degeneration  1  1/81 (1.23%) 
Retinal haemorrhage  1  1/81 (1.23%) 
Gastrointestinal disorders   
Peritonitis  1  1/81 (1.23%) 
Infections and infestations   
Pyelonephritis  1  1/81 (1.23%) 
Psychiatric disorders   
Suicide attempt  1  1/81 (1.23%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (v12.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pegaptanib Sodium
Affected / at Risk (%)
Total   28 
Eye disorders   
Conjunctival haemorrhage  1  6/81 (7.41%) 
Eye pain  1  7/81 (8.64%) 
Macular degeneration  1  8/81 (9.88%) 
Myodesopsia  1  12/81 (14.81%) 
General disorders   
Pain  1  5/81 (6.17%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (v12.0)
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 < 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), < 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: NCT00324116     History of Changes
Other Study ID Numbers: A5751016
First Submitted: May 8, 2006
First Posted: May 10, 2006
Results First Submitted: August 25, 2009
Results First Posted: October 2, 2009
Last Update Posted: March 23, 2010