Abstract
Purpose :
To report the 3-year visual and anatomic outcomes, safety, and compliance for patients undergoing endolaserless vitrectomy with intravitreal aflibercept injection (IAI) monotherapy for proliferative diabetic retinopathy (PDR)-related vitreous hemorrhage (VH).
Methods :
Eyes underwent endolaserless vitrectomy and received one preoperative and intraoperative IAI followed by randomization to a q8week or q16week IAI group. Additional IAI for PDR progression or DME was administered as needed. Non-compliance was defined as missing >3 consecutive or >6 mandatory appointments. Q8week eyes were evaluated at week 104 for PDR stability and were transitioned to q16week IAI dosing for year 3 if appropriate. Q16week eyes were subject to q8week conversion at any time point if they experienced 2 episodes of recurrent VH.
Results :
31/40 eyes were randomized (14 and 17 eyes in q8week and q16week groups, respectively) with 25/31 (81%) randomized eyes completing 152 weeks. Compliance criteria was met by 10/14 (71%) and 9/17 (53%) eyes in the q8 and q16week groups, respectively. Through 104 weeks, q8 and q16week eyes received an average of 14.4 and 8.8 IAI, respectively. At week 104, 8/14 (57%) q8week eyes were converted to q16week IAI and 3/17 (18%) q16week eyes were converted to q8week IAI. Q8week eyes observed an increase in visual acuity (VA) of 34 letters from 41 to 75 letters (20/160 to 20/32) (p=0.003) compared to an increase of 27 letters from 48 to 75 letters (20/100 to 20/32) in the q16week group (p=0.013). Adverse ocular events in compliant patients included worsening VA > 30 letters at any timepoint (3 q8week eyes, 6 q16week eyes) and VH (2 q8week eyes, 6 q16week eyes). One case of neovascular glaucoma was seen in the q16week group and 1 retinal detachment occurred in both q8 and q16week groups. In addition, recurrent VH was experienced by 1 compliant q8week eye compared to 3 compliant q16weeks eyes.
Conclusions :
Endolaserless vitrectomy with aflibercept monotherapy for PDR-related VH has shown to provide significant long-term visual gains. Frequent IAI is required to achieve fewer proliferative consequences. Non-compliance remains a patient-centered issue, further indicating the need for persistent and frequent postoperative anti-VEGF therapy. This data may provide a foundation for evaluating longer acting anti-VEGF treatment modalities with this approach.
This is a 2021 ARVO Annual Meeting abstract.