SUMMIT: Combination Therapy With Verteporfin PDT and Ranibizumab for Subfoveal Choroidal Neovascularization Due to AMD

Abstract

Purpose:: In a previous clinical trial, verteporfin (Visudyne^®) photodynamic therapy (PDT) was safely combined with ranibizumab (Lucentis^TM), and resulted in improved efficacy in patients with exudative age-related macular degeneration (AMD). The SUMMIT trial program was designed to further explore the efficacy and safety of combination therapy of verteporfin and ranibizumab, as well as the impact of the combination on treatment burden and health economics outcomes.

Design:: DENALI in the United States and Canada and MONT BLANC in Europe. Enrollment criteria are: ≥50 years of age, with any type of subfoveal CNV secondary to AMD, lesion size <9 DA, naïve to AMD treatment, and a best-corrected visual acuity (BCVA) letter score of 73-24 (Snellen equivalent 20/40 to 20/320). In DENALI, patients will be randomly assigned to the monthly 0.5 mg ranibizumab monotherapy arm, or one of two combination treatment arms: verteporfin standard fluence (light dose 50 J/cm²) or reduced fluence (light dose 25 J/cm²) at baseline plus intravitreal injection of 0.5 mg ranibizumab at baseline and months 1 and 2, followed from month 3 by ranibizumab as needed and verteporfin standard or reduced fluence as needed. Study outcomes include efficacy and safety (BCVA, FA, and OCT measurements), treatment burden of combination therapy (number of retreatments, time to first retreatment, treatment-free interval), and health economics outcomes.

Methods:: SUMMIT is a clinical development program designed to evaluate the efficacy and safety of verteporfin PDT combined with ranibizumab in combination compared with ranibizumab monotherapy in patients with subfoveal choroidal neovascularization (CNV) due to AMD. The SUMMIT program will include two 12-month randomized, controlled trials of similar

Results:: The rationale for combination therapy with verteporfin and ranibizumab, and the study design will be presented.

Conclusions:: Results from the SUMMIT program will provide important insight into the efficacy, safety, treatment practice, and health economics outcomes of combination therapy with verteporfin PDT and ranibizumab in patients with wet AMD.

Keywords: age-related macular degeneration • photodynamic therapy • choroid: neovascularization