Randomized multicenter trial of more intense and standard early verteporfin treatment of neovascular age-related macular degeneration.

Purpose: To compare efficacy and safety of a more intense regimen versus a standard one for retreatment of neovascular age-related macular degeneration (AMD) during the early period of verteporfin therapy (VT).

Design: Prospective, randomized, multicenter clinical trial.

Participants: Two hundred three patients with predominantly classic choroidal neovascularization (CNV) secondary to AMD.

Methods: During the first 6 months of VT, patients underwent retreatment every 2 (group A) or 3 (group B) months. After 6 months, both groups underwent retreatment every 3 months for as long as CNV activity was documented.

Main Outcome Measures: Best-corrected visual acuity (BCVA) measured every 6 months, mean number of treatments per patient during 24 months' follow-up, proportions of patients in each group losing at least 3 lines of vision or gaining at least 1 line, greatest linear dimension (GLD) of the lesion as documented by fluorescein angiography every 6 months, and relationship between initial lesion size and BCVA.

Results: At all follow-up times, mean BCVAs were similar for groups A and B. Mean numbers of photodynamic therapy treatments were similar for both groups (4.07 vs. 4.36; P = 0.451, paired t test). A lower proportion (51.9% vs. 56.7%) of patients in group A had lost at least 3 lines of vision at 24 months. Groups A and B had similar increases in mean lesion size from baseline to 24 months (2104-3056 microm and 2179-3020 microm). At 24 months, patients in group A with a baseline lesion GLD of < or =2000 microm had significantly less mean loss of vision than patients in group A with a GLD of >2000 microm (P = 0.032); differences also were significant for group A with GLD of < or =2000 microm versus group B with GLD of < or =2000 microm (P = 0.041) or GLD of >2000 microm (P = 0.045); and mean vision losses from baseline were 8, 17, 15, and 14 letters, respectively.

Conclusions: Overall outcomes regarding visual benefit, lesion anatomic features, and number of retreatments after 6 months were similar for patients receiving more intense or standard early therapy. An unplanned retrospective analysis showed that there was significantly less vision loss when the more intense regimen was used to treat smaller lesions.