Experimental drug improves sight of patients with wet AMD

Ninety-five percent of patients with the wet form of age-related macular degeneration (AMD) who were treated with ranibizumab (Lucentis, Genentech) experienced an increase in visual acuity after 1 year, according to a second phase III study presented at Macula 2006 in New York.

The ANCHOR (Anti-VEGF Antibody for the Treatment of Predominantly Classic Choroidal Neovascularization in AMD) study compared ranibuzumab with verteporfin (Visudyne, Novartis Ophthalmics/QLT Inc.) photodynamic therapy (PDT) in 423 patients with predominantly classic wet AMD. The phase III trial is a randomized, 2-year, multicenter, double-masked, active treatment controlled study with three arms-0.3 mg of ranibizumab, 0.5 mg of ranibizumab, and PDT.

After 12 months of treatment, the first group gained an average of 8.5 letters, the second group gained an average of 11 letters, and the third group lost an average of 9.5 letters. All visual acuity outcomes were measured by the Early Treatment of Diabetic Retinopathy Study eye chart.

The study also found:

•  Ninety-four percent of patients in the first arm and 96% of those treated in the second arm lost fewer than 15 letters compared with baseline (the primary efficacy endpoint), compared with 64% of those treated with PDT.

•  More than one-third of patients treated in the first arm and 40% of patients treated in the second arm experienced improved vision of 15 letters or more, compared with about 6% of patients treated with PDT.

•  Less than one-third of patients treated in the first arm and 39% of patients treated in the second arm achieved visual acuity of 20/40 or better after 1 year, compared with about 3% of patients treated with PDT.

"[Ranibizumab] is the first investigational therapy that has shown improved vision, not just a slowing of vision loss, in patients with all types of wet AMD," said presenter Peter K. Kaiser, MD, director, Clinical Research Center, The Cleveland Clinic Cole Eye Institute, Cleveland, OH. "As a result, physicians may be one step closer to being able to set a new expectation for the future treatment of this condition."

Common mild-to-moderate ocular side effects, occurring more frequently in the investigational arms, included conjunctival hemorrhage, increased IOP, eye pain, and vitreous floaters. Uncommon yet serious ocular side effects, occurring more frequently in the investigational arms, included endophthalmitis and intraocular inflammation. These serious side effects were reported in less an 1% of patients per investigational arm.