Complications, Compliance and 2 Year Outcomes after Endolaserless Vitrectomy with Aflibercept Monotherapy for PDR-Related Vitreous Hemorrhage

Abstract

Purpose : Anti-VEGF monotherapy is a demonstrated alternative to panretinal photocoagulation for PDR eyes not requiring vitrectomy. For PDR-related VH requiring vitrectomy, intravitreal aflibercept injection (IAI) monotherapy without endolaser PRP (endolaserless) may be a viable approach. We report the 2-year visual and anatomic outcomes, safety, and compliance for patients undergoing endolaserless vitrectomy with IAI for PDR-related VH.

Methods : Phase I/II open label, randomized, prospective, single center interventional study. Randomized eyes underwent endolaserless vitrectomy and 2mg IAI. Eyes received a pre and intraoperative IAI then randomization to a q8week group receiving 4 post-operative q4week IAI followed by q8 week IAI or a q16week group receiving 2 post-operative q4week IAI followed by q16week IAI. Mandatory ocular exam and OCT were performed monthly in year 1 and every two months in year 2. Additional IAI for PDR progression or DME was administered as needed. Non-compliance was defined as missing >3 consecutive or >4 mandatory appointments in 1 year.

Results : Thirty one of 40 eyes were randomized with 22 eyes completing 104 weeks (10/13 (77%) q8wk and 9/15 (60%) q16wk eyes). Q8week and Q16week eyes received an average of 14.3 and 8.6 IAI, respectively. Visual acuity (VA) improvements were superior in the q8week group with an increase of 37 letters (from 38 to 74) at week 104 (p = 0.0026) versus an increase of 14 letters (from 51 to 65) at week 104 in the q16week group (p=0.167). At week 104, 0 and 3 eyes in the q8week and q16week groups, respectively, observed a decrease in VA from baseline (range: -19 to -2 letters). Significant adverse ocular events through 104 weeks were more common in the q16week group including worsening VA > 30 letters at any time point (4 eyes in q8week, 7 eyes in q16week group) and recurrent VH (2 eyes in q8week, 7 eyes in q16week). One case of NVG was seen in the q16week group and 1 rhegmatogenous retinal detachment in both q8 and q16eyes.

Conclusions : Endolaserless vitrectomy with aflibercept monotherapy for PDR-related VH results in significant visual gains. The greater rates of proliferative consequences in the q16week group, poor compliance rate in both groups, and greater Q8wk VA gains indicate that persistent, frequent postoperative anti-VEGF therapy is necessary to optimize visual outcomes and reduce complications.

This is a 2020 ARVO Annual Meeting abstract.