At a glance
ClinicalIndex Comparison Record- ✓Age 50 years or older
- ✓Subfoveal choroidal neovascularization secondary to age-related macular degeneration
- ✕Choroidal neovascularization from causes other than AMD
- ✕Prior treatment for neovascular AMD in the study eye
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A 24-month Randomized, Double-masked, Controlled, Multicenter, Phase IIIB Study Assessing Safety and Efficacy of Verteporfin Photodynamic Therapy Administered in Conjunction With Ranibizumab Versus Ranibizumab Monotherapy in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-related Macular Degeneration
In Brief
A Phase 3 clinical trial evaluating Verteporfin Photodynamic Therapy, Ranibizumab, and 2 other interventions for Macular Degeneration and Choroidal Neovascularization. Completed, enrolled 321 participants across 43 sites in 2 countries.
Detailed Summary
This study evaluated the effect of combination therapy with verteporfin photodynamic therapy and ranibizumab on visual acuity and anatomic outcomes compared to ranibizumab monotherapy and the durability of response observed in patients with choroidal neovascularization secondary to age-related macular degeneration.
Study Details
Timeline
Interventions
After a 10-minute intravenous infusion of verteporfin at a dose of 6 mg/m\^2 body surface area, verteporfin was activated by light application of 50 J/cm\^2 (Standard Fluence rate) or 25 J/cm\^2 (Reduced Fluence rate) to the study eye, begun 15 minutes after the start of the infusion.
Ranibizumab 0.5 mg administered as an intravitreal injection.
To maintain masking, as a placebo for verteporfin photodynamic therapy, patients were administered a 10-minute intravenous infusion of 5% dextrose solution, followed by light application of 50 J/cm\^2 to the study eye, begun 15 minutes after the start of infusion.
To maintain masking, patients in the combination groups received sham intravitreal injections whenever retreatment with active Ranibizumab was not warranted based on the retreatment algorithm.