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A Study On The Efficacy Of Macugen Injections In Patients With Neovascular Age-Related Macular Degeneration In Real Life. (MACURELI)

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ClinicalTrials.gov Identifier: NCT00549055
Recruitment Status : Completed
First Posted : October 25, 2007
Results First Posted : October 27, 2010
Last Update Posted : December 6, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Other
Condition Neovascular Age-related Macular Degeneration
Intervention Drug: Macugen
Enrollment 38
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Macugen
Hide Arm/Group Description Intraocular injections of Macugen into the treated eye. The use and dosage recommendations for Macugen took place on the basis of the approved package insert.
Period Title: Overall Study
Started 38
Completed 3
Not Completed 35
Reason Not Completed
Adverse Event             4
Lack of Efficacy             18
Stabilization             5
Progression to fibrosis             2
Decrease of size             1
Active choroidal neovascula increased             1
Vitreous hemorrhage             1
Growth choroidal neovascularisation             1
Choroidal neovascularization             1
Very low visual acuity (VA)             1
Arm/Group Title Macugen
Hide Arm/Group Description Intraocular injections of Macugen into the treated eye. The use and dosage recommendations for Macugen took place on the basis of the approved package insert.
Overall Number of Baseline Participants 38
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 38 participants
< 65 years 3
65 to 74 years 8
75 to 84 years 22
>= 85 years 5
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants
Female
14
  36.8%
Male
24
  63.2%
1.Primary Outcome
Title Change From Baseline to Final Visit in Visual Acuity (VA) Score
Hide Description Best corrected VA score, assessed on the scale over time (best corrected VA score at Final Visit minus best corrected VA score at Baseline). Lower scores represent poorer eyesight and higher scores represent better eyesight with a value of 1 representing normal eyesight. A positive change in score represents an improvement in sight.
Time Frame Baseline, Month 24 or Early Termination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) was derived from the set of all enrolled participants who were administered at least 1 injection of the study medication and had at least 1 post Baseline efficacy measurement. Participants analyzed refers to number of participants with analyzable data.
Arm/Group Title Macugen
Hide Arm/Group Description:
Intraocular injections of Macugen into the treated eye. The use and dosage recommendations for Macugen took place on the basis of the approved package insert.
Overall Number of Participants Analyzed 28
Mean (Standard Deviation)
Unit of Measure: Scores on scale
-0.044  (0.122)
2.Secondary Outcome
Title Number of Participants With Change in VA: Improvement
Hide Description Investigator's clinical judgement of Improvement in status of vision as compared to the previous Macugen injection, calculated from measurement of the difference between the VA scores at the 2 visits.
Time Frame Months 3, 6, 9 and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS; n= number of participants with analyzable data.
Arm/Group Title Macugen
Hide Arm/Group Description:
Intraocular injections of Macugen into the treated eye. The use and dosage recommendations for Macugen took place on the basis of the approved package insert.
Overall Number of Participants Analyzed 30
Measure Type: Number
Unit of Measure: Participants
Month 3 (n=18) 3
Month 6 (n=5) 1
Month 9 (n=2) 1
Month 12 (n=2) 1
3.Secondary Outcome
Title Number of Participants With Change in VA: Stabilization
Hide Description Investigator's clinical judgement as Stabilization in status of visual acuity as compared to the previous Macugen injection, determined from measurement difference between the VA scores at the 2 visits.
Time Frame Months 3, 6, 9 and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS; n= number of participants with analyzable data.
Arm/Group Title Macugen
Hide Arm/Group Description:
Intraocular injections of Macugen into the treated eye. The use and dosage recommendations for Macugen took place on the basis of the approved package insert.
Overall Number of Participants Analyzed 30
Measure Type: Number
Unit of Measure: Participants
Month 3 (n=18) 11
Month 6 (n=5) 2
Month 9 (n=2) 0
Month 12 (n=2) 1
4.Secondary Outcome
Title Number of Participants With Change in VA: Worsening
Hide Description Investigator's clinical judgement as Worsening in status of vision as compared to the previous Macugen injection, determined from measurement difference between the VA scores at the 2 visits.
Time Frame Months 3, 6, 9 and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS; n= number of participants with analyzable data.
Arm/Group Title Macugen
Hide Arm/Group Description:
Intraocular injections of Macugen into the treated eye. The use and dosage recommendations for Macugen took place on the basis of the approved package insert.
Overall Number of Participants Analyzed 30
Measure Type: Number
Unit of Measure: Participants
Month 3 (n=18) 4
Month 6 (n=5) 2
Month 9 (n=2) 1
Month 12 (n=2) 0
5.Secondary Outcome
Title Duration of Treatment
Hide Description Duration of treatment per participant calculated as: date of injection (for the last injection of Macugen) minus date of injection (for the first injection of Macugen).
Time Frame Baseline up to 28.4 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Macugen
Hide Arm/Group Description:
Intraocular injections of Macugen into the treated eye. The use and dosage recommendations for Macugen took place on the basis of the approved package insert.
Overall Number of Participants Analyzed 30
Mean (Standard Deviation)
Unit of Measure: Months
4.66  (5.26)
6.Secondary Outcome
Title Frequency of Macugen Administration
Hide Description Average frequency of Macugen administration per participant calculated as: (number of Macugen injections administered per participant – 1)/ duration of treatment.
Time Frame Baseline up to 28.4 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Macugen
Hide Arm/Group Description:
Intraocular injections of Macugen into the treated eye. The use and dosage recommendations for Macugen took place on the basis of the approved package insert.
Overall Number of Participants Analyzed 30
Mean (Standard Deviation)
Unit of Measure: Weeks per injection
7.74  (4.80)
7.Secondary Outcome
Title Number of Participants Who Received Other Concomitant Age Related Macular Degeneration (AMD) Treatments
Hide Description Derived by whether a participant took any other AMD treatments at any time (at any Study Treatment Visit).
Time Frame Months 3, 6, 9 and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Macugen
Hide Arm/Group Description:
Intraocular injections of Macugen into the treated eye. The use and dosage recommendations for Macugen took place on the basis of the approved package insert.
Overall Number of Participants Analyzed 30
Measure Type: Number
Unit of Measure: Participants
4
Time Frame [Not Specified]
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title Macugen
Hide Arm/Group Description Intraocular injections of Macugen into the treated eye. The use and dosage recommendations for Macugen took place on the basis of the approved package insert.
All-Cause Mortality
Macugen
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Macugen
Affected / at Risk (%)
Total   0/38 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Macugen
Affected / at Risk (%)
Total   2/38 (5.26%) 
Eye disorders   
Myodesopsia  1  2/38 (5.26%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.1
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: Pfizer
ClinicalTrials.gov Identifier: NCT00549055     History of Changes
Other Study ID Numbers: A5751026
First Submitted: October 23, 2007
First Posted: October 25, 2007
Results First Submitted: October 1, 2010
Results First Posted: October 27, 2010
Last Update Posted: December 6, 2018