The Fate of 47/53: regression of diabetic retinopathy with ranibizumab in patients with diabetic macular edema and highest-risk non-proliferative diabetic retinopathy

Session Details

Session Title: Free Paper Session 19: Vascular Diseases & Diabetic Retinopathy V

Session Date/Time: Saturday 09/09/2017 | 16:30-18:00

Paper Time: 17:24

Venue: Room 120

First Author: : I.Stoilov ARGENTINA

Co Author(s): :    L. Hill   C. Quezada Ruiz   Z. Haskova   P. Schlottmann                    

Abstract Details

Purpose:

To explore the effects of ranibizumab on diabetic retinopathy (DR) severity in patients with diabetic macular edema (DME) and moderately severe or severe non-proliferative diabetic retinopathy (NPDR) at baseline who were at the highest risk of progression to proliferative DR.

Setting:

This was a retrospective, post hoc analysis of DR severity data from the RIDE/RISE clinical trials. Analysis focused on patients with moderately severe to severe NPDR at baseline (Early Treatment Diabetic Retinopathy Study DR Severity Scale [ETDRS-DRSS] level 47/53), who were at the highest risk of progression to proliferative DR.

Methods:

In the randomized phase 3 RIDE (NCT00473382) and RISE (NCT00473330) clinical studies, patients with DR and DME (N=759) received monthly sham or ranibizumab (0.3-mg or 0.5-mg) injections for 24 months. DR severity was graded using ETDRS-DRSS. DR outcomes were evaluated over time in patients with highest-risk NPDR (ETDRS-DRSS 47/53) at baseline. Potential baseline predictors of DR severity improvements with ranibizumab treatment were also examined.

Results:

At baseline, 33% (n=248) of patients had highest-risk NPDR (ETDRS-DRSS level 47/53) and they were equally distributed among treatment groups. More than 75% of these patients treated with ranibizumab experienced ≥2-step DR improvements at months 12 and 24 compared with <12% of sham-treated patients. At month 24, <3% of ranibizumab-treated patients experienced ≥2-step DR worsening compared with 15% of sham-treated patients. Ranibizumab also reduced the incidence of new proliferative events compared with sham at month 24 (5.7% and 9.5% vs 24.4% for ranibizumab 0.3 mg, ranibizumab 0.5 mg, and sham, respectively). Baseline mean central foveal thickness (CFT), best-corrected visual acuity (BCVA), and duration of diabetes were similar in ranibizumab-treated patients who experienced ≥2-step DR improvement at month 24 compared with those who did not. These baseline characteristics were not predictive of ≥2-step DR improvement at month 24 (P>0.05).

Conclusions:

Among RIDE and RISE patients with highest-risk NPDR at baseline, ranibizumab treatment resulted in statistically significant and clinically meaningful DR severity improvements in >75% of patients. Ranibizumab treatment also reduced DR worsening compared with sham treatment. DR reversal was independent of baseline values for CFT, BCVA, and diabetes duration, suggesting that these baseline characteristics do not impact the effectiveness of ranibizumab for DR in patients with moderately severe to severe NPDR with DME.

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