Ranibizumab shows continued safety, efficacy over longer-term follow-up

INDIAN WELLS, Calif. — Intravitreal injections of ranibizumab continue to show a good safety and efficacy profile as a treatment option for patients with neovascular age-related macular degeneration at 3.8 years follow-up, according to a speaker here.

"It appears that repeated intravitreal injections of ranibizumab (Lucentis, Genentech) are safe and well-tolerated. There did not seem to be any safety signals systemically with longer-term use," said David S. Boyer, MD, at the American Society of Retina Specialists annual meeting.

Dr. Boyer presented results of Extension Study 2508, which enrolled 70 patients from three Genentech-sponsored phase 1/2 trials who were eligible for continued treatment.

Specifically, the study enrolled two patients from Study 1770, 44 from Study 2128 and 24 from Study 2425. Of these, 67 patients continued with ranibizumab treatment for up to 3.8 years.

The study was conducted between September 2002 and October 2006.

"These patients ... received 0.3 mg of ranibizumab every month," Dr. Boyer said. "An amendment was then formed in June 2003, and the dose was elevated to 0.5 mg, but injections were at the discretion of the investigators if the lesions were stable and there was no visual loss."

"The total number of injections received also varied," he said. The initial study involved an average of seven injections, while the extension study had an average of 11 injections, ranging from one to 44 injections.

The researchers observed vitritis in approximately 12% of patients and retinal hemorrhage in approximately 27% of patients. Additional adverse events included conjunctival hemorrhage and reduced visual acuity.

All patients maintained their visual acuity improvements achieved since starting the studies, Dr. Boyer said.