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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
317
Clinicians decision to use optional laser therapy.
Intravitreal injection of Macugen 0.3mg/90ul every 6 weeks up to 2 years.
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
Time frame: Baseline, Year 1
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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: Baseline, Year 1
Number of Eyes With a 2 or More Step Decrease in Degree of Retinopathy at 1 Year
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Pfizer Investigational Site
Phoenix, Arizona, United States
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Tucson, Arizona, United States
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Los Angeles, California, United States
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Oakland, California, United States
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Santa Ana, California, United States
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Denver, Colorado, United States
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Hamden, Connecticut, United States
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Fort Lauderdale, Florida, United States
Pfizer Investigational Site
Tampa, Florida, United States
Pfizer Investigational Site
Tampa, Florida, United States
...and 63 more locations
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 2 years