Predictors of Early Diabetic Retinopathy Regression with Ranibizumab in the RIDE and RISE Clinical Trials
Michael Singer,1 Mimi Liu,2 Patricio G Schlottmann,3 Arshad M Khanani,4 Miranda Hemphill,5 Lauren Hill,5 Lisa Tuomi,5 Zdenka Haskova5 1Medical Center Ophthalmology Associates, San Antonio, TX, USA; 2Colorado Retina Associates, Denver, CO, USA; 3Organizacion Medica de Investigacion, Buenos Aires, Arg...
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| Formato: | article |
| Lenguaje: | EN |
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Dove Medical Press
2020
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| Acceso en línea: | https://doaj.org/article/bb4def1039f742bd8d26c58fd00fc64b |
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| Sumario: | Michael Singer,1 Mimi Liu,2 Patricio G Schlottmann,3 Arshad M Khanani,4 Miranda Hemphill,5 Lauren Hill,5 Lisa Tuomi,5 Zdenka Haskova5 1Medical Center Ophthalmology Associates, San Antonio, TX, USA; 2Colorado Retina Associates, Denver, CO, USA; 3Organizacion Medica de Investigacion, Buenos Aires, Argentina; 4Sierra Eye Associates, Reno, NV, USA; 5Genentech, Inc., South San Francisco, CA, USACorrespondence: Michael SingerMedical Center Ophthalmology Associates, 9157 Huebner Road, San Antonio, TX 78240, USATel +1 210 269 3754Fax +1 210 558 7679Email msinger11@me.comPurpose: To investigate the predictors of early diabetic retinopathy (DR) improvement in the RIDE/RISE (NCT00473382/NCT00473330) clinical trials.Patients and Methods: In RIDE/RISE, adult patients with vision loss due to diabetic macular edema (DME) were randomized to monthly intravitreal ranibizumab 0.3 or 0.5 mg (n=502 total) or sham (n=257). DR severity was graded (using the Early Treatment Diabetic Retinopathy Study Diabetic Retinopathy Severity Scale). In this post hoc analysis of RIDE/RISE, eyes with baseline DR score ≥ 35 were evaluated for ≥ 2-step improvements, and eyes with baseline DR score ≥ 43 were evaluated for ≥ 3-step improvements. The characteristics associated with ≥ 2- or ≥ 3-step DR improvement at months 3 or 6 were assessed using univariate and/or multivariable analyses.Results: The percentage of eyes with a ≥ 2- or ≥ 3-step DR improvement was 20.1% and 3.7% at month 3 and 31.2% and 5.8% at month 6. Odds of ≥ 2-step DR improvement at months 3 or 6 were significantly greater in eyes with moderately severe to severe nonproliferative DR (NPDR) at baseline versus less severe or more severe DR (both P< 0.0001). At month 6, odds of ≥ 2-step DR improvement were significantly greater in eyes with no DME at month 3 (P=0.008). Most patients with ≥ 3-step DR improvement at months 3 or 6 had proliferative DR (PDR) at baseline (83.3% and 66.7%).Conclusion: The strongest predictors of DR response to ranibizumab at month 6 were baseline DR severity and DME quiescence at month 3. Eyes with the most robust early improvements had moderately severe or severe NPDR or PDR at baseline.Keywords: diabetic retinopathy, ranibizumab, anti-VEGF, diabetic macular edema, post hoc |
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