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Dilsher Dhoot, Lauren Hill, Kathleen Tarnowski, Ivaylo Stoilov; Baseline factors associated with ≥ 2-step diabetic retinopathy (DR) severity improvement with ranibizumab (RBZ). Invest. Ophthalmol. Vis. Sci. 2018;59(9):3592.
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In RIDE and RISE, RBZ induced clinically and statistically significant improvements in DR disease severity compared with sham treatment. Herein, we examined which baseline characteristics were associated with ≥ 2-step DR severity improvements.
In the sham-controlled portion of the phase 3 RIDE (NCT00473382)/RISE (NCT00473330) studies, patients with diabetic macular edema (DME) (N=759) received monthly sham or RBZ (0.3-mg or 0.5-mg) injections for 24 months. All patients meeting prespecified rescue criteria after month 3 could receive laser treatment. DR severity was assessed prospectively throughout the trial using the Early Treatment Diabetic Retinopathy Study DR severity scale. We retrospectively evaluated potential baseline factors associated with ≥ 2-step DR severity improvements at months 12 and 24.
RBZ resulted in ≥ 2-step improvement in DR severity in 32.5% (152/468) and 36.8% (172/468) of RBZ-treated patients at months 12 and 24, respectively. Baseline demographic and ocular characteristics were assessed for predictive value for DR severity improvement. For RBZ-treated patients, age, duration of diabetes, DR severity, fluorescein angiogram (FA) leakage, and retinal non-perfusion (RNP) were associated with ≥ 2-step DR improvement at both months 12 and 24 (P<0.01). Subretinal fluid was a significant predictor of DR improvement at month 12 (P=0.005), but was not significant at month 24. Patients who showed DR severity improvement were younger by approximately 3 years, had a shorter duration of diabetes by approximately 4 years, were more likely to have baseline DR severity level 47–53, had greater FA leakage, and were more likely to have RNP. Multivariate logistic regression analyses showed baseline DR severity was predictive of DR severity improvement at month 12 (P<0.0001) and DR severity and RNP were significant predictors at month 24 (P<0.0001 and P=0.02, respectively).
At months 12 and 24, younger age, shorter duration of diabetes, DR severity level 47–53 at baseline, greater FA leakage at baseline, and baseline RNP were significantly associated with greater rates of ≥ 2-step DR severity improvement in RBZ-treated patients. These results are consistent with previous findings of RBZ treatment for DR and DME and highlight the importance of early diagnosis and prompt treatment.
This is an abstract that was submitted for the 2018 ARVO Annual Meeting, held in Honolulu, Hawaii, April 29 - May 3, 2018.
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