BCVA gain seen with ranibizumab therapy

April 29, 2008

A gain of at least 15 letters of best-corrected visual acuity (BCVA) was seen in a greater percentage of patients with age-related macular degeneration (AMD) who received monthly or quarterly doses of 0.5 mg ranibizumab (Lucentis, Genetech) than in patients treated with either verteporfin (Visudyne, Novartis) therapy or sham, according to 2-year data from the MARINA, ANCHOR, and PIER trials discussed by Sebastian Wolf, MD, PhD, University of Bern, Switzerland.

A gain of at least 15 letters of best-corrected visual acuity (BCVA) was seen in a greater percentage ofpatients with age-related macular degeneration (AMD) who received monthly or quarterly doses of 0.5 mgranibizumab (Lucentis, Genentech) than in patients treated with either verteporfin (Visudyne, Novartis) therapyor sham, according to 2-year data from the MARINA, ANCHOR, and PIER trials discussed by Sebastian Wolf, MD, PhD,University of Bern, Switzerland.

The quarterly treatment regimen demonstrated a smaller gain in BCVA than the other regimens, but the gain inBCVA was maintained in both the monthly and quarterly ranibizumab regimens over 2 years in all three of thephase III, randomized, double-masked trials.

In the MARINA trial, 716 patients with minimally classic or occult lesions received monthly treatment with 0.3or 0.5 mg of ranibizumab for 2 years, he said. In the ANCHOR study, 423 patients with predominantly classiclesions were treated either monthly with the aforementioned doses of ranibizumab or quarterly with verteporfinphotodynamic therapy for 2 years. In the PIER trial, 184 patients with neovascular AMD were treated with eitherof the ranibizumab doses on a monthly basis for the first 3 months then once every 3 months for 2 years. Anamendment during the second year of the trial allowed patients to be rolled over from the quarterly dosingregimen to the monthly one.

Investigators used the standard Early Treatment Diabetic Retinopathy Study chart to assess BCVA and measure thepercentages of patients who gained visual acuity in letters from baseline. Thirty-four percent of patients inthe MARINA trial who received 0.5 mg of ranibizumab had a BCVA gain of more than 15 letters at year one, and thesame gain was seen in 33% at year 2. In the ANCHOR study, the results were 40% and 41%, respectively, and in thePIER trial, findings were 13% and 8%, respectively. At least 6% of patients gained more than 30 letters at yearone.