Title
Reduced Fluence Visudyne-Anti-VEGF-Dexamethasone In Combination for AMD Lesions (RADICAL)
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.
Phase
Phase 2Lead Sponsor
Novelion TherapeuticsStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Choroidal Neovascularization Macular DegenerationIntervention/Treatment
ranibizumab urea verteporfin ...Study Participants
162The 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.
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
0.5 mg intravitreal injection
Very low fluence Visudyne followed by intravitreal Lucentis-Dexamethasone triple therapy [within 2 hours] administered on Day 0, and then as required every 2 months thereafter
Reduced-fluence Visudyne followed by intravitreal Lucentis-Dexamethasone triple therapy [within 2 hours] administered on Day 0, and then as required every 2 months thereafter
Reduced-fluence Visudyne followed by Lucentis double therapy [within 2 hours] administered on Day 0, and then as required every 2 months thereafter
Lucentis monotherapy administered on Day 0, Month 1 and Month 2, and then as required monthly thereafter
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) < 5400 microns (approximately = or <9 disc areas [DA]) Best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA score) of 25 - 73 letters (approximate Snellen equivalent of 20/40 - 20/320), inclusive Exclusion Criteria: Subfoveal geographic atrophy or subfoveal fibrosis of the study eye Intraocular surgery within 3 months of enrollment Inability to attend the protocol-required visits Known allergies or hypersensitivity to any of the study treatments. Other systemic diseases or active uncontrolled infections that would make subject a poor medical risk Uncontrolled glaucoma, defined as (1)subject is on >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
| Event Type | Organ System | Event Term | 1/4 Fluence Triple Therapy | 1/2 Fluence Triple Therapy | 1/2 Fluence Double Therapy | Ranibizumab |
|---|
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.
Early Treatment Diabetic Retinopathy Study (ETDRS) method at 4 meters. Worst = 0; best = 100
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.
Early Treatment Diabetic Retinopathy Study (ETDRS) method at 4 meters. Worst = 0; best = 100
Mean change from baseline in lesion size measured as greatest linear dimension (GLD) of the lesion
