CLINICAL TRIALS Verteporfin Therapy of Subfoveal Minimally Classic Choroidal Neovascularization in Age-Related Macular Degeneration 2-Year Results of a Randomized Clinical Trial Visudyne in Minimally Classic Choroidal Neovascularization Study Group*

Methods: We randomly assigned 117 patients (1:1:1) to verteporfin infusion (6 mg/m) and light application with an RF rate (300 mW/cm) for 83 seconds (light dose of 25 J/cm) or an SF rate (600 mW/cm) for 83 seconds (light dose of 50 J/cm) or to placebo infusion with RF or SF. Treatment was repeated every 3 months if the treating physician noted fluorescein leakage from CNV on angiography. Patients in whom a predominantly classic lesion developed could receive open-label standard verteporfin treatment. Best-corrected visual acuity was measured every 3 months, and angiographic changes were assessed by the Photograph Reading Center through the 3-month examination unless an ocular adverse event or conversion to a predominantly classic lesion was identified by an investigator. Safety was assessed throughout the study. All outcomes were on an intent-to-treat basis. Results: One hundred three (88%) of 117 patients completed the 24-month examination. Twelve (30%) of 40 patients assigned to placebo received open-label standard verteporfin treatmentafterconfirmationofpresenceofpredominantly classic CNV. At month 12, a loss of at least 3 linesofvisualacuityoccurredin5(14%)of36eyesassigned to RF and 10 (28%) of 36 eyes assigned to SF, compared with 18 (47%) of 38 eyes assigned to placebo (RF, P=.002; SF,P=.08;RF SF,P=.004).Atmonth24,thislossoccurred in 9 (26%) of 34 eyes assigned to RF and 17 (53%) of 32 assignedtoSF,comparedwith23(62%)of37eyesassigned to placebo (RF, P=.003; SF, P=.45; RF SF, P=.03). Progression to predominantly classic CNV by 24 months was more common in the placebo group (11 [28%] of 39 patients compared with 2 [5%] of 38 in the RF group [P=.007] and 1 [3%] of 37 in the SF group [P=.002]). No unexpected ocular or systemic adverse events were identified.Treatment-related,usuallytransientvisualdisturbances were 13% with SF, 10% with placebo, and 5% with RF.