Abstract
Abstract: :
Purpose: To evaluate the effect and safety outcomes of verteporfin (Visudyne®, Novartis AG) therapy compared with placebo (sham treatment) in patients with occult with no classic subfoveal CNV secondary to AMD. Methods: A randomized, placebo–controlled, double–masked, multicenter, phase III study. Patients with occult with no classic subfoveal lesions as determined by a Reading Center were included. Other eligibility criteria were: age ≥50 years, visual acuity between 20/40 and 20/200, and a lesion size of ≤6 MPS disc areas. Lesions of >4 MPS disc areas associated with a best–corrected visual acuity score of ≥20/50 were not eligible. Patients were randomly assigned (2:1) to verteporfin (6 mg/m2) or placebo (5% D5W) administered via a 10–minute intravenous infusion followed by light application (50 J/cm2) 15 minutes after the start of infusion (600 mW/cm2 for 83 seconds). Patients will be treated at the initial visit and at 3–monthly intervals up to 21 months if evidence of fluorescein leakage from CNV is detected by angiography. Best–corrected visual acuity, fluorescein angiographic outcomes, and safety will be assessed at each examination through 24 months. ICG angiography and optical coherence tomography will be performed at baseline and selected examinations up to 24 months. A Data and Safety Monitoring Committee and a Study Advisory Group will oversee the safety and conduct of this trial. Results: Study design and baseline characteristics will be presented. Conclusions:This study aims to confirm the potential benefit of verteporfin therapy in occult with no classic lesions in patients with subfoveal CNV secondary to AMD as demonstrated in the VIP Trial. This study is currently in progress.
Keywords: age–related macular degeneration • choroid: neovascularization • photodynamic therapy