Intravitreal Aflibercept Injection (IAI) for Persistent Diabetic Macular Edema (DME) after Treatment
with Bevacizumab and/or Ranibizumab: 6-Month ROTATED Trial Results

Abstract

Purpose : There is limited prospective data evaluating the safety and efficacy of 2.0 mg intravitreal aflibercept in eyes with persistent DME after treatment with bevacizumab and/or ranibizumab. We evaluated the safety and efficacy of 2.0 mg intravitreal aflibercept in these eyes with persistent DME despite previous anti-VEGF (vascular endothelial growth factor) therapy.

Methods : The ROTATED Trial is an open-label, prospective, non-randomized, single-center, interventional study of 2.0 mg IAI in eyes with persistent DME after chronic, recent, and frequent bevacizumab and/or ranibizumab. Inclusion criteria required eyes to have received at least 6 bevacizumab/ranibizumab injections within 9 months and at least 2 bevacizumab/ranibizumab injection within 3 months of enrollment. Study eyes received five initial monthly intravitreal aflibercept doses of 2.0 mg followed by 2q8 week intravitreal aflibercept injections for a total of 52 weeks.

Results : Twenty five of 30 anticipated enrolled eyes have completed 24-week follow up. At baseline, mean best-corrected visual acuuity (BCVA) was 65 (Snellen equivalent 20/100) ETDRS letters. Mean baseline OCT central subfield thickness (CST) was 460 um. At 24 weeks, mean BCVA was 69 (Snellen equivalent 20/80) letters. Average BCVA increased 6 letters at 24 weeks, with 18 of 25 eyes gaining ≥ 0 letters at 24 weeks. At 24 weeks, average OCT CST decreased 69 um (mean CST = 408um) from baseline; 13 of 25 eyes decreased CST by at least 10% from baseline through 24 weeks. Adverse events included 2 subconjunctival hemorrhages, blurry vision, trace epiretinal membrane, elevated blood pressure, and vertigo. Serious systemic adverse events included one ruptured hernia and one death due to a myocardial infarction. No endophthalmitis, retinal tears, detachments, or vitreous hemorrhages were observed.

Conclusions : Intravitreal aflibercept may provide additional visual acuity and anatomic benefit for eyes with persistent DME after recent, chronic, and frequent bevacizumab/ranibizumab.

This is an abstract that was submitted for the 2018 ARVO Annual Meeting, held in Honolulu, Hawaii, April 29 - May 3, 2018.