JUN 03, 2013
This prospective, phase 3, randomized study found that 0.5 mg ranibizumab, when dosed monthly, provided better results than other dosing regimens after one year in patients with previously untreated wet AMD.
The study compared the safety and efficacy of 2.0 mg and 0.5 mg ranibizumab in 1,098 subfoveal wet AMD patients at least 50 years of age. They were randomized to intravitreal injections of 0.5 mg or 2.0 mg ranibizumab administered monthly or on a PRN basis after three monthly loading doses.
Although all treatment groups demonstrated clinically meaningful visual improvement and improved anatomic outcomes after one year, vision gains were highest in the 0.5 mg ranibizumab per month group, which showed a change in BCVA of 10.1 letters, compared to 9.2 letters for the 2.0 mg monthly group, 8.2 letters for the 0.5 mg PRN group, and 8.6 letters for the 2.0 mg PRN group. The PRN groups required approximately four fewer injections (6.9 - 7.7) than the monthly groups (11.2 - 11.3).
The incidence of ocular adverse events was consistent with previous ranibizumab trials in wet AMD and comparable among groups, with no apparent dose-related trends between the 0.5 mg and 2.0 mg groups. Moreover, there were no apparent dose-exposure-related trends between the monthly and the PRN groups. Serious adverse events were rare.