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A Multicenter, Randomized, Single-masked Study Comparing Reduced-fluence Visudyne®-Lucentis® Combination Therapies and Lucentis® Monotherapy in Subjects With Choroidal Neovascularization (CNV) Secondary to AMD. (RADICAL)
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.
Details
| Lead sponsor | QLT Inc. |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 162 |
| Start date | 2007-07 |
| Completion | 2010-05 |
Conditions
- Choroidal Neovascularization
- Macular Degeneration
Interventions
- verteporfin
- verteporfin
- ranibizumab
- dexamethasone
Primary outcomes
- Mean Number of Retreatments (Day 0 Excluded) — Month 1 to Month 12
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. - Mean Change From Baseline in Study Eye Best-corrected VA Score (ETDRS Chart) — Baseline to Month 12
Early Treatment Diabetic Retinopathy Study (ETDRS) method at 4 meters. Worst = 0; best = 100
Countries
United States, Canada