Early results from triple therapy trial show increase in visual acuity, fewer treatments

Issue: February 25, 2009

WAILEA, Hawaii — The 6-month results of a randomized clinical trial looking at therapy combining an anti-VEGF, photodynamic therapy and steroids showed safety as well as an increase in visual acuity while subjecting patients to fewer treatments, a speaker said here.

Henry L. Hudson

"The triple therapy arm showed the greatest visual gain, followed by ranibizumab, followed by the double therapy arm," Henry L. Hudson, MD, FACS, said at Retina 2009. "There is no serious deleterious effect of combination therapy vs. monotherapy thus far in this trial."

The study is following 162 patients older than 50 years who have subfoveal choroidal neovascularization. The patients were randomized to receive triple therapy with Lucentis (ranibizumab, Genentech), PDT with Visudyne (verteporfin, Novartis/QLT) and dexamethasone; double therapy with ranibizumab and PDT; or monotherapy with PDT or ranibizumab.

At 6 months, the triple therapy group showed the most gain in visual acuity when compared with monotherapy and double therapy. In addition, patients receiving monotherapy required 3.5 treatments while combination therapy treatments, both triple and double, averaged two treatments.

"Cumulative re-treatment rates were lower in the combination group," Dr. Hudson said. "It's a little early to determine what this final number is going to be."

These preliminary results demonstrate the importance of the RADICAL clinical trial. The vitreoretinal community needs answers to determine whether combination therapy with photodynamic therapy and intravitreal corticosteroids in conjunction with anti-VEGF agents is safe, improves efficacy and may reduce the burden of intravitreal injections of anti-VEGF drugs. We look forward to long-term results that will provide guidance to these important questions

– Elias Reichel, MD
New England Eye Center, Tufts University School of Medicine, Boston