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Two dosing levels of ranibizumab show good effects in eyes with DME
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.
Perspective
Back to TopFerrone and Jonisch present a 12-month, single-center, prospective randomized comparison between 0.5 mg and 1 mg ranibizumab for the treatment of refractory clinically significant diabetic macular edema. Patients received three monthly injections followed by as-needed treatment bimonthly.
This study was initiated around the same time as the RIDE/RISE studies and prior to FDA approval of 0.3 mg ranibizumab for clinically significant DME, when only 0.5 mg ranibizumab was FDA approved for the treatment of neovascular macular degeneration. The goal was to determine if a higher dose (1 mg) of ranibizumab might be more beneficial due to the diffuse nature and higher intraocular VEGF concentrations of DME compared with neovascular AMD.
Patients in both groups received 6.5 injections over 12 months, had improved visual acuity, and had decreased central foveal thickness and macular volume. Limitations included selection of refractory cases, as-needed dosing schedule, single-center design, less than monthly follow-up and small sample size (23 eyes in each group). BCVA improvement in the ranibizumab 1 mg group and decrease in central foveal thickness and macular volume in both groups were statistically significant. Importantly, the risk of adverse events was comparable.
This study assessed clinically pertinent patients with refractory DME and sought to address the effect of increased ranibizumab dosing. Due to study limitations, lower BCVA gains were noted compared with RISE/RIDE. While the effect of dose-doubling and frequency of treatment remains to be established, this study demonstrated a trend toward improved outcomes with higher-dose ranibizumab.
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Ferrone PJ, et al. Ophthalmic Surg Lasers Imaging Retina. 2016;doi:10.3928/23258160-20160601-05.