The objective of this study is to determine if combination therapy (reduced-fluence Visudyne followed by Lucentis \[within 2 hours\] or either of two regimens of reduced-fluence Visudyne followed by Lucentis-Dexamethasone triple therapy \[within 2 hours\]) reduces retreatment rates compared with Lucentis monotherapy while maintaining similar vision outcomes and an acceptable safety profile.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
162
Reduced-fluence Visudyne (25 J/cm2, 300 mW/cm2, 83 seconds)
Very-low fluence Visudyne (15 J/cm2, 180 mW/cm2, 83 seconds)
0.5 mg intravitreal injection
Unnamed facility
Mobile, Alabama, United States
Unnamed facility
Phoenix, Arizona, United States
Mean Number of Retreatments (Day 0 Excluded)
Retreatment was defined in the protocol as study treatment administered after Day 0. For the analyses of retreatment, any study treatment that was administered was considered to be a retreatment, and combination therapy was considered to be one retreatment, even though two or three treatment procedures were done. In the combination therapy groups, if a ranibizumab injection was given because retreatment was indicated and the previous combination treatment was less than 2 months before, the ranibizumab injection was counted as a retreatment.
Time frame: Month 1 to Month 12
Mean Change From Baseline in Study Eye Best-corrected VA Score (ETDRS Chart)
Early Treatment Diabetic Retinopathy Study (ETDRS) method at 4 meters. Worst = 0; best = 100
Time frame: Baseline to Month 12
Mean Number of Retreatments (Day 0 Excluded)
Retreatment was defined in the protocol as study treatment administered after Day 0. For the analyses of retreatment, any study treatment that was administered was considered to be a retreatment, and combination therapy was considered to be one retreatment, even though two or three treatment procedures were done. In the combination therapy groups, if a ranibizumab injection was given because retreatment was indicated and the previous combination treatment was less than 2 months before, the ranibizumab injection was counted as a retreatment.
Time frame: Month 1 to Month 24
Mean Change From Baseline in Study Eye Best-Corrected VA Score
Early Treatment Diabetic Retinopathy Study (ETDRS) method at 4 meters. Worst = 0; best = 100
Time frame: Baseline to Month 24
Percentage of Subjects With >=15 Letters of Visual Acuity Gained From Baseline
Time frame: Baseline to Month 12, Baseline to Month 24
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0.5 mg intravitreal injection
Retina Centers, PC
Tucson, Arizona, United States
Unnamed facility
Beverly Hills, California, United States
Unnamed facility
Campbell, California, United States
Unnamed facility
Los Angeles, California, United States
Unnamed facility
Poway, California, United States
Unnamed facility
Sacramento, California, United States
Unnamed facility
Torrance, California, United States
Unnamed facility
Fort Myers, Florida, United States
...and 16 more locations
Percentage of Subjects With >=0 Letter Gain of Visual Acuity From Baseline
Time frame: Baseline to Month 12, Baseline to Month 24
Percentage of Subjects With >=15 Letters of Visual Acuity Lost From Baseline
Time frame: Baseline to Month 12, Baseline to Month 24
Mean Change From Baseline in Central Retinal Thickness
Time frame: Baseline to Month 12, Baseline to Month 24
Mean Change From Baseline in Lesion Size
Mean change from baseline in lesion size measured as greatest linear dimension (GLD) of the lesion
Time frame: Baseline to Month 12, Baseline to Month 24