Lucentis well tolerated in extension study with reduced dosage

FORT LAUDERDALE, Fla. — Ranibizumab was well tolerated in patients with age-related macular degeneration who received a reduced dosage of the drug for more than a year after an initial clinical trial, according to a poster presentation here.

“Subjects receiving Lucentis [ranibizumab, Genentech] had stable visual acuity and stable lesion characteristics despite a reduced frequency of injections,” Jeffrey S. Heier, MD, and colleagues reported at the Association for Research in Vision and Ophthalmology meeting. Patients from phases 1 and 2 of the Lucentis clinical trials who lost less than 15 letters of vision during the trials (94%) were eligible for the extension study.

A total of 70 patients enrolled in the extension trial. Due to a study protocol amendment, the initial dose of 0.3 mg was increased to 0.5 mg per injection. Injection frequency was reduced from one injection every 4 weeks to a flexible dosing interval that relied on visual acuity and lesion characteristics to determine the treatment schedule, Dr. Heier said.

At the final follow-up visit (mean 415 days), patients averaged 0.22 injections every 4 weeks. The study authors said that “ranibizumab continued to be well tolerated” and visual acuity remained stable.

Adverse events included conjunctival hemorrhage, increased IOP, blurred vision, iris and uveal tract inflammation. These side effects were mild or moderate in all patients, Dr. Heier said.