Photodynamic therapy of subfoveal choroidal neovascularization in pathologic myopia with verteporfin - 1-year results of a randomized clinical trial - VIP report no. 1

Objective: To determine if photodynamic therapy with verteporfin (Visudyne; CIBA Vision Corp, Duluth, GA) can improve the chance of stabilizing or imp roving vision (<8 letter loss) safely in patients with subfoveal choroidal neovascularization (CNV) caused by pathologic myopia. Design: Multicenter, double-masked, placebo-controlled, randomized clinical trial at 28 ophthalmology practices in Europe and North America. Participants: One hundred twenty patients with subfoveal CNV caused by path ologic myopia with a greatest linear dimension no more than 5400 <mu>m and best-corrected visual acuity (Snellen equivalent) of approximately 20/100 o r better. Intervention: Patients were randomly assigned (2:1) to verteporfin (6 mg pe r square meter of body surface area; n = 81) or placebo (5% dextrose in wat er, n = 39) administered via intravenous infusion of 30 ml over 10 minutes. Fifteen minutes after the start of the infusion, a laser light at 689 nm w as delivered at an intensity of 600 mW/cm(2) over 83 seconds to give a ligh t dose of 50 J/cm(2) to a round spot size on the retina with a diameter of 1000 mum larger than the greatest linear dimension of the choroidal neovasc ular lesion. At follow-up examinations every 3 months, retreatment with eit her verteporfin or placebo (as assigned at baseline) was applied to areas o f fluorescein leakage if present. Main Outcome Measures: The primary outcome was the proportion of eyes at th e follow-up examination 12 months after study entry with fewer than eight l etters (approximately 1.5 lines) of visual acuity lost, adhering to an inte nt-to-treat analysis. Results: At baseline, move than 90% of each group had evidence of classic C NV (regardless of whether occult CNV was present) and only 12 (15%) and 5 ( 13%) cases in the verteporfin and placebo groups, respectively, had occult CNV (regardless of whether classic CNV was present). Seventy-nine of the 81 verteporfin-treated patients (98%) compared with 36 of the 39 placebo-trea ted patients (92%) completed the month 12 examination. Visual acuity, contr ast sensitivity, and fluorescein angiographic outcomes were better in the v erteporfin-treated eyes than in the placebo-treated eyes at every follow-up examination through the month 12 examination. At the month 12 examination, 58 (72%) of the verteporfin-treated patients compared with 17 (44%) of the placebo-treated patients lost fewer than eight letters (P < 0.01), includi ng 26 (32%) versus 6 (15%) improving at least five letters (<greater than o r equal to>1 line). Seventy (86%) of the verteporfin-treated patients compa red with 26 (67%) of the placebo-treated patients lost fewer than 15 letter s (P = 0.01), Few ocular or other systemic adverse events were associated w ith verteporfin therapy compared with placebo treatment. Conclusions: Because photodynamic therapy with verteporfin can safely incre ase the chance of stabilizing or improving vision in patients with subfovea l CNV from pathologic myopia compared with a placebo, we recommend ophthalm ologists consider verteporfin therapy for treatment of such patients. Ophth almology 2001; 108:841-852 (C) 2001 by the American Academy of Ophthalmolog y.