Abstract
Purpose :
There is limited prospective data evaluating the safety and efficacy of 2.0 mg IAI in eyes with persistent DME after treatment with bevacizumab and/or ranibizumab. We evaluated the safety and potential efficacy of 2.0 mg IAI in eyes with persistent DME after treatment with bevacizumab and/or ranibizumab.
Methods :
ROTATED is an open-label, non-randomized, single-center, interventional clinical trial, prospective 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 receive at least 6 bevacizumab/ranibizumab injections within 9 months and 2 bevacizumab/ranibizumab injections within 3 months of enrollment. Study eyes received five required initial monthly intravitreal aflibercept doses of 2.0 mg followed by 2q8 IAI for a total of 52 weeks.
Results :
Twenty three of 30 enrolled eyes have completed 52-week follow up. At baseline, mean BCVA was 64 (Snellen equivalent 20/50)(range 36-83) ETDRS letters. Mean baseline OCT CST was 459μm (range 310-721μm). At 24 weeks, mean BCVA was 69 (Snellen equivalent 20/40) letters. Average visual acuity (VA) increased 5 letters (range -9 to +21 letters) with 22 of 27 eyes gaining ≥ 0 letters. At 24 weeks, average OCT CST thinned 54μm (mean CST=409μm)(range 245-891μm); 20 of 27 eyes decreased thickness by at least 10% from baseline through 24 weeks. Through 52 weeks, eyes received an average of 9 (range 5-11) IAI. At 52 weeks, mean BCVA was 72 (Snellen equivalent 20/40) letters. Average VA increased 3 letters (range -15 to +22 letters) with 18 of 23 eyes gaining ≥ 0 letters. At 52 weeks, average OCT CST thinned 124μm (mean CST=335μm)(range 204-662μm); 21 of 23 eyes decreased thickness by at least 10% from baseline through 52 weeks. Ocular adverse events (AEs) included subconjunctival hemorrhages, blurry vision, trace epiretinal membrane, and cataract extraction. Endophthalmitis, retinal tears/detachments, or vitreous hemorrhage were not observed. Systemic AEs included elevated blood pressure, influenza, vertigo, and cardiac stent. Serious systemic AEs included 1 ruptured hernia and 1 death due to myocardial infarction.
Conclusions :
IAI may provide additional visual acuity and anatomic benefit for eyes with persistent DME after recent, chronic, and frequent bevacizumab/ranibizumab.
This abstract was presented at the 2019 ARVO Annual Meeting, held in Vancouver, Canada, April 28 - May 2, 2019.