Ranibizumab studies show positive results in wet AMD

August 1, 2005

One-year results from two clinical studies of ranibizumab (Lucentis, Genentech Inc.) among patients with the wet form of age-related macular degeneration (AMD) showed that both trials met the primary endpoint of maintaining visual acuity. The data were presented at the American Society of Retina Specialists’ annual meeting in Montréal.

In one study, patients treated for 12 months gained an average of seven letters in visual acuity compared with study entry, while the control group lost an average of 10.5 letters. A single-masked phase I/II clinical study also was presented that compared a combination treatment of the investigational anti-vascular endothelial growth factor drug with verteporfin for injection (Visudyne, Novartis Ophthalmics Inc./QLT Inc.) photodynamic therapy (PDT) versus PDT alone.

The phase III study, which followed 716 patients, met its primary efficacy endpoint of maintaining vision in patients with AMD. Its secondary endpoint results show there was a 17-letter difference in mean change in visual acuity from study entry between patients treated with ranibizumab (regardless of 0.3- or 0.5-mg dose) and those in the control group-as measured by the Early Treatment of Diabetic Retinopathy Study (ETDRS) eye chart.

“These data are very compelling because, for the first time, we have a potential treatment that has been shown to improve vision in a significant number of patients with wet AMD as opposed to just slowing progression of vision loss,” said presenter Joan W. Miller, MD, retina specialist at the Massachusetts Eye and Ear Infirmary, Boston.

The phase I/II clinical study included 162 patients with the wet form of AMD and met its primary efficacy endpoint of patients maintaining vision. The secondary endpoint results show there was a 13-letter difference in mean change in visual acuity from study entry between the two treatment groups, measured by ETDRS. At 12 months, patients treated with ranibizumab and PDT gained an average of five letters in visual acuity compared with study entry, while the control group lost an average of eight letters.

About one-fourth of patients treated with the combination therapy had improved vision by 15 letters or more compared with study entry, while only 5% of patients treated with PDT alone had improved vision. Further details will be reported in upcoming issues (including the August 15 print edition) of Ophthalmology Times.