Ranibizumab and Verteporfin Photodynamic Therapy for PCV
JAMA Ophthalmology, November 2017
Polypoidal choroidal vasculopathy (PCV) is a type of exudative age-related macular degeneration common to Asians. In the 2008 EVEREST study, ranibizumab plus verteporfin photodynamic therapy (vPDT) was more efficacious than ranibizumab monotherapy in diminishing polypoidal lesions within 6 months. In EVEREST II, Koh et al. investigated longer-term outcomes of these treatments in a large Asian population with PCV. They found that, at 12 months, combination therapy continued to be superior to ranibizumab monotherapy for improving vision and resolving polyps.
In this double-masked multicenter clinical trial, Asian adults with symptomatic macular PCV were assigned randomly to receive intravitreal ranibizumab 0.5 mg with either vPDT (n = 168) or sham PDT (n = 154). Demographic data were similar for the study groups. Ranibizumab injections were administered on day 1 and at months 1 and 2. vPDT or sham PDT (5% dextrose solution) was given on day 1. In both groups, treatments were followed by pro re nata regimens. Main outcome variables were changes in best-corrected visual acuity from baseline to 12 months and effects on polyp regression, as assessed by indocyanine green (ICG) angiography.
At 12 months, mean improvement from baseline to month 12 was 8.3 letters for patients on combination therapy and 5.1 letters for those on monotherapy (mean difference, 3.2 letters), denoting noninferiority as well as superiority of the combined therapy. Complete absence of a polypoidal lesion on ICG angiography by month 12 occurred in 69.3% of patients on dual therapy and only 34.7% of patients on ranibizumab alone. The median numbers of ranibizumab injections were 4 and 7, respectively. Safety profiles were comparable for the 2 study groups.
In conclusion, as ranibizumab plus vPDT was superior to ranibizumab monotherapy, the authors said that combination treatment warrants consideration for patients with PCV. Because dual therapy entails fewer injections overall, it has potential to reduce the costs and overall burden of treatment. (Also see related commentary by David J. Browning, MD, PhD, in the same issue.)
The original article can be found here.