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.
- Conditions
- Macular Edema Associated With Diabetes Mellitus
- Interventions
- Drug: MacugenDrug: Standard of Care
- Registration Number
- NCT00605280
- Lead Sponsor
- Pfizer
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 317
- macular edema associated with diabetes
- visual acuity between 20/50 and 20/200
- recent laser therapy in the eye
- recent signs of uncontrolled diabetes
- blood pressure worse than 160/100
- severe cardiac disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Macugen Macugen - Sham Control Standard of Care -
- Primary Outcome Measures
Name Time Method Number of Participants With Greater Than or Equal to ≥10 Letter (or 2 Line) Improvement in Vision at 1 Year Baseline, Year 1 Refraction and best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts
- Secondary Outcome Measures
Name Time Method Number of Participants With a ≥ 10 Letter (or 2 Line) Improvement in Vision at 2 Years Baseline, Year 2 Refraction and best-corrected VA measurements were performed using retro-illuminated, modified Ferris-Bailey ETDRS charts
Change From Baseline in Mean VA Score at 2 Years Baseline, Year 2 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.
Number of Eyes With a 2 or More Step Increase in Degree of Retinopathy at 1 Year Baseline, Year 1 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.
Number of Participants Requiring Focal or Grid Laser Treatment During Year 2 2 years Included focal laser coagulation, focal laser photocoagulation, panretinal laser photocoagulation, retinal laser coagulation, and retinal laser photocoagulation
Number of Participants With a ≥ 15 Letter Improvement in Vision at 1 Year Baseline, Year 1 Refraction and best-corrected VA measurements were performed using retro-illuminated, modified Ferris-Bailey ETDRS charts
Number of Participants With a ≥ 15 Letter Improvement in Vision at 2 Years Baseline, Year 2 Refraction and best-corrected VA measurements were performed using retro-illuminated, modified Ferris-Bailey ETDRS charts
Number of Eyes With a 2 or More Step Decrease in Degree of Retinopathy at 1 Year Baseline, Year 1 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.
Number of Eyes With a 2 or More Step Increase in Degree of Retinopathy at 2 Years Baseline, Year 2 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.
Number of Eyes With a 2 or More Step Decrease in Degree of Retinopathy at 2 Years Baseline, Year 2 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.
Number of Participants Requiring Focal or Grid Laser Treatment During Year 1 1 year Included focal laser coagulation, focal laser photocoagulation, panretinal laser photocoagulation, retinal laser coagulation, and retinal laser photocoagulation
Change From Baseline in Mean VA Score at 1 Year Baseline, Year 1 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.
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇬🇧Sheffield, United Kingdom