A Canadian 12-month, PhIIIb study of Ranibizumab Combination or Monotherapy in Visual Impairment due to Diabetic Macular Edema: Preliminary Analysis (“RESPOND”)

Abstract

Diabetic macular edema (DME), a common microvascular complication of diabetes mellitus (DM), may negatively affect visual acuity (VA), leading to blindness. Timely diagnosis and treatment may improve outcomes. This study was based on the hypothesis that treatment with ranibizumab (alone or with laser) would show greater improvement in best-corrected VA than laser alone. Eligible patients had stable DM (HbA1c ≤10.0% at baseline), and visual impairment (VI) due to DME deemed eligible for laser treatment. Two hundred forty-one participants were randomized 1:1:1 to ranibizumab (n=81), laser (n=82) or combination treatment (n=78). For combination and monotherapy, ranibizumab was administered as 3 monthly injections, then 10 months prn injections given/withheld based on DME stability criteria. Laser was administered per ETDRS guidelines at intervals ≥3 months. At baseline, the ITT population (n=235) had a mean (± SD) age of 62 (±9.8) years, was 61% male, 86% Caucasian and 86% had type 2 diabetes. Mean time since diagnosis was 17 (±10.1) years for diabetes and 1.7 (±2.7) years for DME. Twelve percent of the laser arm (n=82) was discontinued due to unsatisfactory therapeutic effect; 10% of safety patients (n=237) experienced an SAE. No deaths were reported.Tabled 1Mean Change from Baseline to Month 12CombinationRanibizumabLaserBCVA (ETDRS letters)8.08.70.895% CI(5.9, 10.1)(6.9, 10.5)(–2.2, 3.8)n747667CRT (μm)–145.2–134.7–103.695% CI(–178.4, –112.1)(–167.3, –102.0)(–138.7, –68.5)n747665 Open table in a new tab Preliminary analysis shows ranibizumab (alone or combination) is an effective and safe treatment for VI due to DME.