Abstract
Abstract: :
Purpose: To report two–year efficacy and safety results of verteporfin (Visudyne®, Novartis AG) therapy compared with placebo for minimally classic (classic CNV occupying <50% but >0% of the lesion) subfoveal CNV due to AMD using either a standard or reduced light dose. Methods: Patients (≥50 years) with minimally classic lesions of ≤6 MPS disc areas were randomized (1:1:1) to one of three treatment groups: (1) verteporfin therapy with reduced light fluence (300 mW/cm2) for 83 seconds (25 J/cm2); (2) verteporfin therapy with standard light fluence (600 mW/cm2) for 83 seconds (50 J/cm2); (3) placebo followed by a sham light treatment. Best–corrected visual acuity was assessed through 24 months, and fluorescein and ICG angiography were assessed through 3 months. Safety was also evaluated. Results: Of 117 patients enrolled, 110 (94%) completed the month 12 examination. At baseline, main demographic variables did not appear different among treatment groups. At the month 12 examination, there was no statistically significant difference in the observed loss of at least 15 letters from baseline between the reduced fluence group and the standard fluence group: 5 (14%) of 36 eyes and 10 (28%) of 36 eyes, respectively. However, there was a numerical advantage in favor of the reduced fluence group (P=0.15). Each verteporfin group was less likely to lose at least 15 letters of visual acuity compared with the 18 (47%) of 38 eyes assigned to placebo (reduced fluence group P=0.002; standard fluence group P=0.08). No new safety concerns were noted. Conclusions: Month 12 results suggest that verteporfin therapy may safely reduce the risks of visual acuity loss in patients with minimally classic CNV. These results support evaluating verteporfin therapy in similar lesions within a phase III trial and further investigations into the potential benefits of reduced fluence verteporfin therapy. Results of the month 24 examination will determine if these benefits are sustained.
Keywords: age–related macular degeneration • choroid: neovascularization • photodynamic therapy