The Natural History of Minimally Classic CNV Due to AMD in the VIM Trial: 2–Year Results and the Effect of Verteporfin Therapy on CNV Progression

Abstract

Abstract: : Purpose: To present 24–month results of verteporfin (Visudyne^®, Novartis AG, Basel, Switzerland) therapy for minimally classic subfoveal CNV due to AMD from the Verteporfin In Minimally classic CNV (VIM) Trial, with a discussion of progression to predominantly classic CNV. Methods: Patients (≥50 years) with minimally classic lesions of ≤6 MPS disc areas and baseline visual acuity (VA) Snellen equivalent of 20/250 or better were randomly assigned to one of three treatment groups: verteporfin therapy with reduced light fluence (RF: 300 mW/cm²) for 83 seconds (25 J/cm²), verteporfin therapy with standard light fluence (SF: 600 mW/cm²) for 83 seconds (50 J/cm²), or placebo followed by a sham light treatment. Best–corrected VA was assessed through 24 months. Fluorescein angiography was assessed through 3 months, and then throughout the study only if progression to predominantly classic CNV or an ocular adverse event occurred. All patients who progressed to predominantly classic CNV were eligible for open–label verteporfin therapy with SF. Results: 103 (88%) of 117 patients completed the month 24 examination. By month 24, 23 (62%) of 37 eyes given placebo had a ≥3–line VA loss, compared with 9 (26%) of 34 eyes treated with RF and 17 (53%) of 32 eyes treated with SF (RF, P<0.01; SF, P=0.45; SF + RF, P=0.03). In the placebo group, 11 of 39 eyes (28%) progressed to predominantly classic CNV, compared with 2 of 38 eyes (5%) in the RF group and 1 of 37 eyes (3%) in the SF group. Of the 11 placebo eyes that progressed, 7 progressed by month 3, 1 by month 6, 2 by month 12, and 1 by month 24; 2 receiving verteporfin therapy progressed by month 3 and 1 by month 6. All patients who progressed were subsequently treated with open–label verteporfin therapy with SF. No new safety concerns were noted. Conclusions: Minimally classic lesions in verteporfin–treated eyes were less likely to sustain ≥3–line VA loss and progress to predominantly classic CNV during 24 months of follow–up than those given placebo. The majority of lesions progressed to predominantly classic CNV within the first 6 months, highlighting the importance of early referral and treatment.

Keywords: age-related macular degeneration