Phase 2
N=162
Reduced Fluence Visudyne-Anti-VEGF-Dexamethasone In Combination for AMD Lesions (RADICAL)
Choroidal Neovascularization · Macular Degeneration
Bottom Line
View on ClinicalTrials.gov: NCT00492284 ↗Enrolled (actual)
162
Serious AEs
35.2%
Results posted
Jun 2010
Primary outcome: Primary: Mean Number of Retreatments (Day 0 Excluded) — 3.97; 3.00; 4.05; 5.39 number of retreatments
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- verteporfin (Drug); ranibizumab (Drug); dexamethasone (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- QLT Inc.
- Primary completion
- May 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Number of Retreatments (Day 0 Excluded) |
5.92; 4.34; 5.92; 8.68 | — |
| PRIMARY Mean Change From Baseline in Study Eye Best-corrected VA Score (ETDRS Chart) |
3.6; 6.8; 5.0; 6.5 | — |
| SECONDARY Mean Number of Retreatments (Day 0 Excluded) |
5.92; 4.34; 5.92; 8.68 | — |
| SECONDARY Mean Change From Baseline in Study Eye Best-Corrected VA Score |
-0.2; 1.1; -0.3; 4.4 | — |
| SECONDARY Percentage of Subjects With >=15 Letters of Visual Acuity Gained From Baseline |
25.6; 30.8; 25.6; 24.4; 20.5; 15.4 | — |
| SECONDARY Percentage of Subjects With >=0 Letter Gain of Visual Acuity From Baseline |
64.1; 82.1; 69.8; 70.7; 61.5; 66.7 | — |
| SECONDARY Percentage of Subjects With >=15 Letters of Visual Acuity Lost From Baseline |
12.8; 7.7; 11.6; 7.3; 20.5; 15.4 | — |
| SECONDARY Mean Change From Baseline in Central Retinal Thickness |
-115.9; -122.2; -137.8; -100.3; -110.2; -123.9 | — |
| SECONDARY Mean Change From Baseline in Lesion Size |
77.2; -20.4; 152.0; -192.6; 94.8; -103.3 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Treatment naive for choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) in the study eye except for laser treatment outside the subfoveal area
- Subfoveal CNV due to AMD
- CNV must be = or >50 % of the entire lesion
- All lesion composition types with a lesion greatest linear dimension (GLD) 1 glaucoma medication (includes combination treatments) or (2)subject has glaucoma that could lead to progressive visual field deterioration
- If subject has had a stroke within the last year
Data sourced from ClinicalTrials.gov (NCT00492284). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.