Koh A, et al. - The effectiveness and safety of combination therapy of ranibizumab and verteporfin photodynamic therapy (vPDT) with ranibizumab monotherapy in polypoidal choroidal vasculopathy (PCV) were compared in this study. It was concluded that the combination therapy of ranibizumab plus vPDT was not only noninferior as well as better than ranibizumab monotherapy in best-corrected visual acuity and superior incomplete polyp regression while requiring fewer injections after a year. Combination therapy ought to be considered for eyes with PCV.

Methods

• For this study, they designed a double-masked, multicenter randomized clinical trial.
• This study was conducted on 322 Asian participants with symptomatic macular PCV affirmed by the Central Reading Center utilizing indocyanine green angiography between August 7, 2013, and March 2, 2017.
• Participants were randomized 1:1 to ranibizumab, 0.5 mg, and vPDT (n=168; combination therapy group) or ranibizumab, 0.5 mg, and sham PDT (n=154; monotherapy group).
• All participants received 3 consecutive monthly ranibizumab injections, followed by a pro re nata regimen.
• Participants also received vPDT/sham PDT on day 1, followed by a pro re nata regimen based on the presence of active polypoidal lesions.

Results

• Baseline demographics of the 322 participants were comparable between the treatment groups.
• Mean (SD) age of the patients was 68.1 (8.8) years, and overall, 69.9% of the patients were men.
• At baseline, the overall mean best-corrected visual acuity and mean central subfield thickness were 61.1 letters and 413.3 μm, respectively.
• At 12 months, mean improvement from baseline was 8.3 letters with combination therapy vs 5.1 letters with monotherapy (mean difference, 3.2 letters; 95% CI, 0.4-6.1), indicating that combination therapy met the predefined criterion for noninferiority and in addition being better than monotherapy (P=.01).
• Combination therapy was also better than monotherapy in achieving complete polyp regression at month 12 (69.3% vs 34.7%; P<.001).
• More than a year, the combination therapy group received a median of 4.0 ranibizumab injections compared with 7.0 in the monotherapy group.
• Vitreous hemorrhage was the only ocular serious adverse event (combination therapy group, 1 [0.6%]; monotherapy group, 3 [2.0%]).