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Mitchell Goff, Lauren Hill, Karen Colbert, Ivo Stoilov, David Faber; Baseline diabetic retinopathy severity affects time to clinically meaningful improvements in diabetic retinopathy during ranibizumab treatment. Invest. Ophthalmol. Vis. Sci. 2020;61(7):4035.
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In previous analyses, patients in RIDE/RISE with moderately severe/severe nonproliferative DR (NPDR) at baseline were more likely to achieve clinically meaningful improvements in DR severity with ranibizumab than patients with either less or more severe baseline DR. This new analysis evaluated the relationship between baseline DR severity and time to DR improvement in RIDE/RISE.
RIDE (NCT00473382) and RISE (NCT00473330) were identical phase 3 trials of monthly ranibizumab (0.3 mg and 0.5 mg) in patients with DR and vision loss due to diabetic macular edema. DR severity was prospectively graded from color fundus photographs by masked reading center evaluators using the Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS). In this ad hoc analysis, the main outcome evaluated was time to improvement by ≥ 2 steps in DR severity on the ETDRS-DRSS. Data from the ranibizumab 0.3 mg and 0.5 mg treatment groups were pooled. Eyes with baseline ETDRS-DRSS severity < 35 (mild NPDR) were excluded.
A total of 443 eyes were evaluated. The time to ≥ 2-step DR improvement was significantly shorter among eyes with moderately severe or severe NPDR (ETDRS-DRSS 47/53) at baseline than among eyes with either mild/moderate NPDR (ETDRS-DRSS 35/43) or proliferative DR (PDR; ETDRS-DRSS 60–75 with or without prior panretinal photocoagulation [PRP]) at baseline (P < 0.01; Figure). Very few eyes with PDR and a history of PRP achieved ≥ 2-step DR improvement; among those that did, the time to ≥ 2-step DR improvement was significantly longer than in eyes with no prior PRP (Figure). As has been reported previously, the proportion of patients achieving ≥ 2-step DR improvement at month 6 was greater in eyes with moderately severe or severe NPDR at baseline than in eyes with either less or more severe baseline DR.
Eyes with moderately severe or severe NPDR at baseline achieved more rapid improvements in DR severity during ranibizumab treatment than did eyes with either milder or more severe DR at baseline. These findings support treating eyes with moderately severe or severe NPDR before they progress to PDR.
This is a 2020 ARVO Annual Meeting abstract.
Figure: Time to ≥ 2-step improvement in ETDRS-DRSS by baseline DR severity (Kaplan-Meier plot).
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