Safety and Efficacy of Ranibizumab Treatment in Patients With Diabetic Macular Edema: 12-Months Results of the Resolve Study

Abstract

Purpose: : Evaluate safety and explore effect of ranibizumab in diabetic macular edema (DME).

Methods: : Multi-center, double-masked study involving 151 DME patients treated over 12 months with 6 mg/ml ranibizumab (n=51), 10 mg/ml ranibizumab (n=51), or sham injection (n=49). Three initial monthly injections followed by re-treatment based on success, futility, or safety criteria. Injection volume doubled as of Month 1 if central retinal thickness (CRT) was >300 µm or >225 µm and reduction from prior assessment <50 µm. Laser photocoagulation as rescue medication allowed from Month 3 onwards. Best-corrected visual acuity (BCVA; Early Treatment for Diabetic Retinopathy Study charts) and CRT (optical coherence tomography) were assessed monthly.

Results: : Injection volume doubled in 92% sham and 73/65% ranibizumab patients (6/10 mg/ml). Rescue treatment in 33% sham and 9% ranibizumab patients. Over 12-months, most frequent ocular adverse events (AEs): conjunctival hemorrhage (14% sham, 23% ranibizumab); eye pain (20% sham, 18% ranibizumab). Serious ocular AEs: 1 sham patient (retinal detachment), 4 ranibizumab patients (endophthalmitis, transient retinal artery occlusion, peripheral retinal ischemia). Non-ocular arterial thromboembolic events: 2 sham and 3 ranibizumab (10 mg/ml) patients. Mean BCVA increased and mean CRT decreased continuously over time in ranibizumab patients. Mean change in BCVA from baseline to Month 12 was -1.4 letters (sham) +11.8 letters (6 mg/ml), +8.8 letters (10 mg/ml), and +10.3 letters (pooled ranibizumab groups).

Conclusions: : Safety of ranibizumab in DME was comparable to previous studies of neovascular AMD. Ranibizumab treatment demonstrated superior efficacy to sham treatment in DME and was associated with continuous improvement in BCVA and CRT throughout 12 months.

Clinical Trial: : www.clinicaltrials.gov NCT00284050

Keywords: clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • diabetic retinopathy • visual acuity