September 2016
Volume 57, Issue 12
Open Access
ARVO Annual Meeting Abstract  |   September 2016
Ranibizumab induces regression of diabetic retinopathy (DR) in more than three-quarters of patients with high-risk non-proliferative diabetic retinopathy (NPDR) independent of retinal nonperfusion
Author Affiliations & Notes
  • Charles Clifton Wykoff
    Vision Care, Retina Consultants of Houston, Houston, Texas, United States
    Blanton Eye Institute and Houston Methodist Hospital, Houston, Texas, United States
  • Shamika Gune
    Genentech, Inc., South San Francisco, California, United States
  • Lauren Hill
    Genentech, Inc., South San Francisco, California, United States
  • Miranda Hemphill
    Genentech, Inc., South San Francisco, California, United States
  • Zdenka Haskova
    Genentech, Inc., South San Francisco, California, United States
  • Footnotes
    Commercial Relationships   Charles Wykoff, Alcon (C), Alcon/Novartis (F), Alimera Sciences (C), Allegro Ophthalmic (F), Allergan (C), Allergan (R), Allergan (F), Apellis Pharmaceuticals (F), Bayer (C), DRCR.network (F), Genentech, Inc. (C), Genentech/Roche (F), Iconic Therapeutics (F), Regeneron (C), Regeneron (R), Regeneron/Bayer (F), Roche (C), Thrombogenics (C), Valeant (C); Shamika Gune, Genentech, Inc. (E); Lauren Hill, Genentech, Inc. (E); Miranda Hemphill, Genentech, Inc. (E); Zdenka Haskova, Genentech, Inc. (E)
  • Footnotes
    Support  Genentech, Inc., South San Francisco, CA, provided support for the study and participated in the study design; conducting the study; and data collection, management, and interpretation.
Investigative Ophthalmology & Visual Science September 2016, Vol.57, No Pagination Specified. doi:
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      Charles Clifton Wykoff, Shamika Gune, Lauren Hill, Miranda Hemphill, Zdenka Haskova; Ranibizumab induces regression of diabetic retinopathy (DR) in more than three-quarters of patients with high-risk non-proliferative diabetic retinopathy (NPDR) independent of retinal nonperfusion. Invest. Ophthalmol. Vis. Sci. 201657(12):.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : DR is a progressive disease, and patients with moderately severe or severe NPDR (levels 47 and 53, respectively, on the Early Treatment Diabetic Retinopathy Study [ETDRS] DR Severity Scale [DRSS]) are at high risk of worsening to proliferative DR (PDR) (ETDRS Report 12, Ophthalmology, 1991). The effect of ranibizumab (RBZ) therapy on DR in patients with diabetic macular edema (DME) at high risk of worsening to PDR was evaluated in this post hoc analysis of RIDE/RISE.

Methods : In the randomized phase 3 RIDE/RISE studies, patients with DME (N=759) received monthly RBZ (0.3 mg or 0.5 mg) or sham injections for 24 months. DR severity was graded on the ETDRS-DRSS by masked evaluators using 7-field fundus photographs. Retinal nonperfusion was evaluated by fluorescein angiography. Outcomes by baseline DR severity were retrospectively analyzed.

Results : At baseline, 33% of patients in RIDE/RISE had moderately severe or severe NPDR (ETDRS-DRSS level 47/53) and these patients were evenly distributed among the treatment groups (88, 74, and 86 patients for 0.3 mg RBZ, 0.5 mg RBZ, and sham, respectively). Among these patients, rates of ≥2-step DR improvement were significantly greater for RBZ-treated patients vs sham at months 12 (76.1%, 75.7%, and 2.3% for 0.3 mg RBZ, 0.5 mg RBZ, and sham, respectively) and 24 (78.4%, 81.1%, and 11.6%, respectively) (all RBZ vs sham comparisons, P<0.0001); these improvements were independent of the presence or absence of retinal nonperfusion at baseline. Respective rates of ≥3-step DR improvement at month 24 were 22.7%, 28.4%, and 1.2% (each RBZ arm vs sham, P<0.0001). In addition, fewer RBZ-treated patients progressed to PDR (ETDRS-DRSS ≥60) compared with sham-treated patients at months 12 (0%, 0%, and 10.5% for 0.3 mg RBZ, 0.5 mg RBZ, and sham, respectively) and 24 (0%, 2.7%, and 18.6%, respectively).

Conclusions : Ranibizumab treatment resulted in statistically significant and clinically meaningful regression of DR to milder severity in the large majority of patients at high risk of progression to PDR, independent of retinal nonperfusion. More than 75% of ranibizumab-treated patients with moderately severe or severe NPDR (ETDRS-DRSS 47/53) experienced ≥2-step DR improvements at 12 and 24 months, and almost none worsened to PDR.

This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.

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