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Two dosing levels of ranibizumab improved visual acuity and decreased central foveal thickness in patients with clinically significant diabetic macular edema, a study found.
The prospective study included 46 eyes of 46 patients with DME secondary to diabetic retinopathy. Patients were randomized 1:1 to receive intravitreal injections of 0.5 mg or 1 mg Lucentis (ranibizumab, Genentech) once monthly for 3 months and subsequently once every other month as needed.
ETDRS best corrected visual acuity, time-domain OCT, fluorescein angiography and color fundus photography were evaluated monthly for the first 4 months and every other month up to 12 months.
Mean number of injections in both groups was 6.5; seven patients received one to four injections, and 39 patients received five to eight injections.
The 0.5-mg group had a mean gain in BCVA of 3.8 letters, which was not statistically significant, and the 1-mg group had a mean gain of 7.9 letters (P = .03); the between-group difference was not statistically significant.
More patients in the 1-mg group than the 0.5-mg group gained 15 or more letters from baseline to 12 months, but the difference was not statistically significant.
Decreases in central foveal thickness from baseline were significant in both groups at 12 months (both P = .0001).
“Although there was a trend showing more drug effect with 1 mg compared with 0.5 mg, there were no statistically significant differences between the two dose groups,” the study authors said. – by Matt Hasson
Disclosure: Ferrone reports he serves on the scientific advisory board and speakers bureau for Genentech.
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