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L. L. Hansen, Resolve Study Group; Visual Acuity Response to Ranibizumab Treatment Based on Baseline Characteristics of Diabetic Macular Edema Patients in the RESOLVE Study. Invest. Ophthalmol. Vis. Sci. 2010;51(13):5841.
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The overall efficacy and safety of ranibizumab in diabetic macular edema (DME) was demonstrated in the RESOLVE study. This analysis was performed to identify disease characteristics that may serve as predictors for BCVA outcome under the RESOLVE study treatment condition.
RESOLVE was a multicenter, double-masked, RCT involving 151 DME patients treated over 12 months with 6 mg/ml ranibizumab (n=51), 10 mg/ml ranibizumab (n=51), or sham injection (n=49). Three initial monthly injections were followed by re-treatment based on success, futility, or safety criteria. The efficacy variable for this analysis was the mean average BCVA change from baseline to Months 1-12. Subgroups were analyzed with the following baseline characteristics: CRT, DME type, diabetes type, prior laser treatment, BCVA, gender, age, diabetes duration, DME duration, ETDRS severity score, HbA1C, and blood pressure.
The mean average BCVA change from baseline to Months 1-12 was 7.8 letters for ranibizumab (pooled groups) vs. -0.1 letters for sham (p<0.0001). Corresponding results of subgroup analysis for pooled ranibizumab vs. sham groups are shown as a table.
Subgroup analyses show that compared to sham, ranibizumab consistently improves BCVA in all DME patient subgroups in the RESOLVE study with largest difference in the central retinal thickness, diabetes type, and diabetes duration subgroups. Further studies are needed to confirm these findings.
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