A Multi-Center Trial To Evaluate The Safety And Efficacy Of Pegaptanib Sodium(Macugen) Injected Into The Eye Every 6 Weeks For Up To 2 Years For Macular Swelling Associated With Diabetes, With An Open-Label Macugen Year Extension.

Study Overview
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Brief Summary
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The purpose of the study is to test whether Macugen injected into the eye improves vision in more patients than the currently existing standard of care laser therapy. The safety of Macugen compared to standard of care laser will also be evaluated.

Official Title
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A Phase 2/3 Randomized, Controlled, Double-Masked, Multi-Center, Comparative Trial, In Parallel Groups, To Compare The Safety And Efficacy Of Intravitreous Injections Of 0.3 Mg Pegaptanib Sodium (Macugen®), Given As Often As Every 6 Weeks For 2 Years, To Sham Injections In Subjects With Diabetic Macular Edema (DME) Involving The Center Of The Macula With An Open-Label Macugen Year 3 Extension.

Conditions
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Macular Edema Associated With Diabetes Mellitus

Intervention / Treatment
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* Drug: Standard of Care
* Drug: Macugen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: macular edema associated with diabetes visual acuity between 20/50 and 20/200 Exclusion Criteria: recent laser therapy in the eye recent signs of uncontrolled diabetes blood pressure worse than 160/100 severe cardiac disease

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Sham Control<br> | Drug: Standard of Care<br>* Clinicians decision to use optional laser therapy.<br>|
| Experimental: Macugen<br> | Drug: Macugen<br>* Intravitreal injection of Macugen 0.3mg/90ul every 6 weeks up to 2 years.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Greater Than or Equal to ≥10 Letter (or 2 Line) Improvement in Vision at 1 Year | Refraction and best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts | Baseline, Year 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With a ≥ 10 Letter (or 2 Line) Improvement in Vision at 2 Years | Refraction and best-corrected VA measurements were performed using retro-illuminated, modified Ferris-Bailey ETDRS charts | Baseline, Year 2 | 
| Number of Participants With a ≥ 15 Letter Improvement in Vision at 1 Year | Refraction and best-corrected VA measurements were performed using retro-illuminated, modified Ferris-Bailey ETDRS charts | Baseline, Year 1 | 
| Number of Participants With a ≥ 15 Letter Improvement in Vision at 2 Years | Refraction and best-corrected VA measurements were performed using retro-illuminated, modified Ferris-Bailey ETDRS charts | Baseline, Year 2 | 
| Number of Eyes With a 2 or More Step Increase in Degree of Retinopathy at 1 Year | Retinopathy changes were monitored using fundus photography and fluorescein angiograph (FA) assessments. An Independent Reading Center, using trained graders, evaluated the presence of retinopathy using a modified 12-step version of the ETDRS Final Retinopathy Severity Scale, that ranged from step 1 (retinopathy level of 10 or 12) to step 12 (retinopathy level of 85A or 85B) where an increase in the step or retinopathy level indicated a worsening of the condition. | Baseline, Year 1 | 
| Number of Eyes With a 2 or More Step Decrease in Degree of Retinopathy at 1 Year | Retinopathy changes were monitored using fundus photography and FA assessments. An Independent Reading Center, using trained graders, evaluated the presence of retinopathy using a modified 12-step version of the ETDRS Final Retinopathy Severity Scale, that ranged from step 1 (retinopathy level of 10 or 12) to step 12 (retinopathy level of 85A or 85B) where a decrease in the step or retinopathy level indicated an improvement. | Baseline, Year 1 | 
| Number of Eyes With a 2 or More Step Increase in Degree of Retinopathy at 2 Years | Retinopathy changes were monitored using fundus photography and FA assessments. An Independent Reading Center, using trained graders, evaluated the presence of retinopathy using a modified 12-step version of the ETDRS Final Retinopathy Severity Scale, that ranged from step 1 (retinopathy level of 10 or 12) to step 12 (retinopathy level of 85A or 85B) where an increase in the step or retinopathy level indicated a worsening of the condition. | Baseline, Year 2 | 
| Number of Eyes With a 2 or More Step Decrease in Degree of Retinopathy at 2 Years | Retinopathy changes were monitored using fundus photography and FA assessments. An Independent Reading Center, using trained graders, evaluated the presence of retinopathy using a modified 12-step version of the ETDRS Final Retinopathy Severity Scale, that ranged from step 1 (retinopathy level of 10 or 12) to step 12 (retinopathy level of 85A or 85B) where a decrease in the step or retinopathy level indicated an improvement. | Baseline, Year 2 | 
| Change From Baseline in Mean VA Score at 1 Year | Changes in VA monitored through refraction and best-corrected VA measurements using retro-illuminated, modified Ferris-Bailey ETDRS chart with participants at a 4-meter distance from chart. Distance VA expressed as an ETDRS score (number of letters correctly read) ranging from 0 to 60, where higher ETDRS scores represented better vision. Change from baseline for each patient equaled the visual acuity obtained at the observation minus the visual acuity at baseline. | Baseline, Year 1 | 
| Change From Baseline in Mean VA Score at 2 Years | Changes in VA monitored through refraction and best-corrected VA measurements using retro-illuminated, modified Ferris-Bailey ETDRS chart with participants at a 4-meter distance from chart. Distance VA expressed as an ETDRS score (number of letters correctly read) ranging from 0 to 60, where higher ETDRS scores represented better vision. Change from baseline for each patient equaled the visual acuity obtained at the observation minus the visual acuity at baseline. | Baseline, Year 2 | 
| Number of Participants Requiring Focal or Grid Laser Treatment During Year 1 | Included focal laser coagulation, focal laser photocoagulation, panretinal laser photocoagulation, retinal laser coagulation, and retinal laser photocoagulation | 1 year | 
| Number of Participants Requiring Focal or Grid Laser Treatment During Year 2 | Included focal laser coagulation, focal laser photocoagulation, panretinal laser photocoagulation, retinal laser coagulation, and retinal laser photocoagulation | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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randomized sham-controlled multicenter macular edema