Abstract
Purpose :
Purpose: Intravitreal aflibercept injection (IAI) may represent a useful therapy with vitrectomy for PDR-related vitreous hemorrhage (VH) as a viable alternative to intraoperative endolaser during vitrectomy. We report the 1-year safety and efficacy when IAI is used for PDR-related VH undergoing endolaserless vitrectomy.
Methods :
Methods: Phase I/II open-label, randomized, prospective, interventional surgical study of endolaserless vitrectomy and 2mg IAI for PDR-related VH.Twenty-one of 24enrolled adults (average age, 55 years (range: 26-77); 21 NIDDM; 67% male; 29% White, 67% African American, 4% Asian; 6 pseudophakic, 18 phakic) with PDR-related VH were randomized after receiving one preoperative and intraoperative IAI. Eyes were randomized to a q8week group receiving 4 postoperative q4week IAI followed by q8week IAI or to a q16week group receiving 2 postoperative q4week IAI followed by q16week IAI. The following were performed monthly: Adverse event monitoring, ETDRS BCVA, IOP measurement, slit lamp biomicroscopy, indirect ophthalmoscopy, and SD-OCT. Quarterly wide-field fluorescein angiography and fundus photography were performed.
Results :
Results: Through 52 weeks, endophthalmitis, progression of traction retinal detachment, iris/angle neovascularization and neovascular glaucoma were not observed. Adverse events at any time through 52 weeks such as worsened visual acuity >30 letters (4 eyes), new rhegmatogenous retinal detachment (1 eye), and recurrent VH (2 eyes) occurred infrequently and were more common in the q16week group. Randomized eyes receiving endolaserless vitrectomy with IAI showed a preoperative average visual acuity (VA) of 36 letters (20/200) with a statistically significant average VA gain of 36 letters to 72 letters (20/40) at 52 weeks (p< 0.0002; one-tailed t-test). Visual acuity outcomes at 52 weeks favored (not statistically significant) the q8week group where average VA was 77 letters (20/32) with a 42 letter gain versus 65 letters (20/50) with a 29 letter gain in the q16week group (p<0.701; two-tailed t-test). The q8week and q16week groups received an average of 8.3 and 5.7 injections, respectively, through 52 weeks.
Conclusions :
Conclusions: Endolaserless vitrectomy with IAI for PDR-related VH demonstrates moderate-term safety with significant VA improvement.
This abstract was presented at the 2019 ARVO Annual Meeting, held in Vancouver, Canada, April 28 - May 2, 2019.