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Durability of diabetic retinopathy improvement with PRN ranibizumab during the RIDE/RISE open-label extension

Session Details

Session Title: Vascular Diseases and Diabetic Retinopathy III

Session Date/Time: Saturday 19/09/2015 | 16:30-18:00

Paper Time: 17:26

Venue: Clio

First Author: : P.Schlottmann ARGENTINA

Co Author(s): :    P. Wang   A. Fung           

Abstract Details

PURPOSE:To determine whether improvements in diabetic retinopathy (DR) achieved with ranibizumab treatment are maintained after conversion from monthly to PRN therapy during the RIDE/RISE open-label extension (OLE).

Setting:

In the 2 identically designed, randomized, phase 3 RIDE and RISE trials, patients (N=759) received monthly 0.3 mg ranibizumab, 0.5 mg ranibizumab, or sham injection with rescue laser for diabetic macular edema (DME).

Methods:

At month 24, patients in the sham arm crossed over to receive monthly 0.5 mg ranibizumab. At month 36, 500 patients entered an open-label extension and were eligible to receive 0.5 mg ranibizumab PRN based on predetermined criteria of worsening vision and evidence of DME on OCT. Seven-field color fundus photographs were taken at baseline and throughout the study. DR severity was graded on the ETDRS DR severity scale (DRSS) by the University of Wisconsin Reading Center. A new composite proliferative DR (PDR) event was defined by the first occurrence of (1) progression from nonproliferative DR (DRSS less than 60) at baseline to PDR (DRSS ≥60) at a later time point, (2) use of pan-retinal photocoagulation (PRP) laser, (3) vitreous hemorrhage (adverse event [AE] or slitlamp grade 0 at baseline to greater than 0 at a later time point), (4) cases identified by ophthalmoscopy, (5) use of vitrectomy for reasons related to DR or its complications, (6) iris neovascularization AE, or (7) retinal neovascularization AE.

Results:

Improvements in DR were rapid and sustained in patients treated with ranibizumab. At month 12, rates of ≥2-step improvement were 34.2%, 30.8%, and 2.5% for 0.3 mg ranibizumab, 0.5 mg ranibizumab, and sham, respectively. Respective rates for ≥3-step improvement were 7.3%, 8.1%, and 1.3%. At month 36, rates of ≥2-step DR improvement were 38.9%, 39.3%, and 23.8% for 0.3 mg ranibizumab, 0.5 mg ranibizumab, and sham/crossover, respectively, and rates of ≥3-step improvement were 15.0%, 13.2%, and 3.8%, respectively. When patients switched to less frequent therapy in the OLE, 75% of patients receiving some treatment and nearly 60% of patients who did not receive any ranibizumab injections maintained the DR levels achieved at month 36. Cumulative probability of PDR-related events at months 12, 24, 36, and 48, respectively, among patients in the OLE was 4.7%, 11.6%, 14.5%, and 20.2% for 0.3 mg ranibizumab, 5.5%, 9.8%, 15.3%, and 19.9% for 0.5 mg ranibizumab, and 18.2%, 29.7%, 35.2%, and 38.2% for sham.

Conclusions:

Monthly ranibizumab injections resulted in rapid improvements in DR that were maintained in the majority of patients with less-than-monthly therapy, despite the fact that retreatment criteria were not based on worsening of DR. Monthly ranibizumab therapy delayed the incidence of PDR-related events with monthly treatment, and switching to PRN treatment did not appear to result in an increased incidence of such events.

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