Abstract
Abstract: :
Purpose: To determine whether early treatment intervals (every 1.5 months during the first 6 months) improve treatment outcomes in patients with predominantly classic CNV due to AMD receiving verteporfin (Visudyne®, Novartis AG) therapy. Methods: 323 patients (≥50 years of age) were randomized 1:1 to receive verteporfin therapy at either early or standard (every 3 months) treatment intervals. Enrollment criteria were a study eye with ≥50% classic CNV, a lesion with a greatest linear dimension of ≤5400 µm, and a best–corrected visual acuity score equivalent to 20/40 to 20/200. All patients received verteporfin therapy at baseline and at 3–month intervals if there was evidence of fluorescein leakage from CNV. If fluorescein leakage was observed at months 1.5 or 4.5, the early treatment group received verteporfin therapy and the standard treatment group received placebo. Best–corrected visual acuity, color fundus photography, fluorescein angiography, and safety outcomes were assessed through month 12. Results: Baseline characteristics between the two groups were well balanced. At baseline, the mean visual acuity letter score was 51.6 (approximate Snellen equivalent 20/100+2) and 166 patients (51.4%) had a lesion size of ≤3 MPS disc areas. The early treatment group received an average of 4.4 treatments (all verteporfin) through month 9 compared with 4.6 treatments in the standard group (verteporfin or placebo). In the standard treatment group at month 12, mean visual acuity had decreased by 14.9 letters (SD=17.1) from baseline; in the early treatment group the month 12 mean visual acuity decrease from baseline was 13.6 letters (SD=18.7). No new safety concerns were noted. Conclusions: The VER Trial did not show that early treatment improved outcomes compared with standard treatment. Based on these findings, the VER Study Group recommends standard treatment intervals when considering verteporfin therapy for predominantly classic lesions.
Keywords: age–related macular degeneration • choroid: neovascularization • photodynamic therapy