NCT00061594
Completed
Phase 3
A Phase III, Multicenter, Randomized, Double Masked, Active Treatment-Controlled Study of the Efficacy and Safety of rhuFab V2 (Ranibizumab) Compared With Verteporfin (Visudyne) Photodynamic Therapy in Subjects With Predominantly Classic Subfoveal Neovascular Age-Related Macular Degeneration
ConditionsMacular Degeneration
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Macular Degeneration
- Sponsor
- Genentech, Inc.
- Enrollment
- 426
- Locations
- 80
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
This is a phase III, multicenter, randomized, double-masked, active treatment-controlled study of intravitreally administered ranibizumab compared with verteporfin (Visudyne) photodynamic therapy (PDT) in treating subfoveal neovascular mascular degeneration.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Signed informed consent
- •Age \>=50 years
- •Eligibility for treatment with PDT using verteporfin in the study eye according to the Visudyne product labeling
- •Future treatment with PDT using verteporfin anticipated or expected in the study eye
- •Primary or recurrent subfoveal choroidal neovascularization (CNV) lesions secondary to age-related macular degeneration (AMD) in the study eye
- •A classic CNV component (well-demarcated hyperfluorescence boundaries in the early phase of the fluorescein angiogram) that is \>=50% of the total lesion size
- •Total lesion size of less than or equal to 5400 um in greatest linear dimension (GLD)
- •Best corrected visual acuity, using Early Treatment of Diabetic Retinopathy Study (ETDRS) charts, of 20/40 to 20/320 (Snellen equivalent) in the study eye
Exclusion Criteria
- •Prior treatment with verteporfin, external-beam radiation therapy, or transpupillary thermotherapy (TTT) in the study eye
- •Treatment with verteporfin in the non-study eye less than 7 days preceding Day 0
- •Previous participation in a clinical trial (for either eye) involving anti angiogenic drugs (pegaptanib, ranibizumab, anecortave acetate, protein kinase C inhibitors, etc.)
- •Previous intravitreal drug delivery (e.g., intravitreal corticosteroid injection or device implantation) in the study eye
- •Previous subfoveal focal laser photocoagulation in the study eye
- •Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1 month preceding Day 0
- •History of vitrectomy surgery in the study eye
- •History of submacular surgery or other surgical intervention for AMD in the study eye
- •Previous participation in any studies of investigational drugs within 1 month preceding Day 0 (excluding vitamins and minerals)
- •Subretinal hemorrhage in the study eye that involves the center of the fovea, if the size of the hemorrhage is either \>=50% of the total lesion area or \>=1 disc area (DA) in size
Outcomes
Primary Outcomes
Not specified
Study Sites (80)
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