Combination Therapy in Neovascular Age-Related Macular Degeneration (amd): A Three-Armed, Randomized, Prospective Clinical Trial of Low Fluence Photodynamic Therapy (rpdt) With Adjunctive Avastin and Triamcinolone Acetonide (Kenalog)(Triple Therapy) versus Rpdt With Adjunctive Avastin (Double Therapy) versus Monotherapy With Avastin

Abstract

Results: : Interim analysis performed with all patients through 6 months showed a statistically significant reduction in the number of interventions in the combination therapy groups over monotherapy with avastin alone. The mean number of treatments at the interim analysis were 4.6 in the monotherapy group, 3.5 in the PDT plus Avastin (p=0.032) and 3.18 in the Triple Therapy group (p=0.0027). Visual acuities showed no statistically significant difference between groups with a mean gain in visual acuity from baseline of 1.7 letters (monotherapy), 1.5 letters (PDT plus avastin) and 0.8 letters (PDT plus avastin and kenalog) at 6 months. A three line or greater gain in visual acuity was seen in 21% Avastin alone, 17% PDT plus Avastin and 12% of Triple Therapy patients while a moderate to severe visual loss occurred in 10%, 11% and 11% of patients respectively. No safety concerns were noted.Final 1 year results will be available March 2009.

Conclusions: : Combination therapy with PDT and Avastin appears to result in a significant reduction in the number of treatment visits required by patients with wet AMD without a significant loss in visual acuity.

Clinical Trial: : www.clinicaltrials.gov NCT00376701

Keywords: age-related macular degeneration • photodynamic therapy