NEW ORLEANS — A long-term open-label extension of the RIDE and RISE trials showed sustained gains in visual acuity in patients receiving ranibizumab for diabetic macular edema, according to a poster presented here.
“The safety profile of ranibizumab in the open-label extension appeared similar to that observed in the controlled core studies, based on the types of [adverse events] reported,” David S. Boyer, MD, and colleagues reported in the poster at the American Academy of Ophthalmology meeting.
The RIDE and RISE trials included 759 patients with DME who received intravitreal injections of Lucentis (ranibizumab, Genentech) for 1 years to 3 years.
Five hundred patients participated in the open-label extension study and received 0.5 mg ranibizumab injections. Patients received an average of 4.5 injections over a period of 14 months.
Of the 500 patients in the extension study, 165 originally received sham injections and crossed over to ranibizumab, 172 originally received 0.3 mg injections of ranibizumab, and 163 originally received 0.5 mg injections of ranibizumab.
Outcome measures of the extension study were incidence and severity of ocular and non-ocular adverse events, best corrected visual acuity and central foveal thickness.
Results showed that 25% of patients did not require additional anti-VEGF therapy and had stable BCVA and central foveal thickness throughout the study.
Seventy-five percent of patients received additional ranibizumab injections but had stable vision at the study endpoint.
“In the extension phase, mean BCVA remained stable in patients continuing from all prior treatment groups,” the authors wrote.
Disclosure: Boyer is a consultant for Genentech.