Abstract
Purpose :
To assess injection burden, visual, anatomic and safety outcomes in PDR eyes after aflibercept monotherapy using wide-field Optos fluorescein angiographic guided therapy.
Methods :
The LASERLESS trial enrolled 40 study eyes with PDR-related vitreous hemorrhage and is evaluating endolaserless vitrectomy with aflibercept monotherapy in a 3-year study. We retrospectively, evaluated 17 non-study fellow LASERLESS trial PDR eyes that received WFFAGA and did not require vitrectomy per investigator discretion at baseline. Fellow eyes, in the trial, prospectively underwent monthly BCVA, OCT, and ocular examinations with quarterly WFFA. After baseline aflibercept, PRN aflibercept dosing was administered for PDR progression based on clinical examination and WFFA evaluation.
Results :
We report 52-week follow-up results in 17 eyes from 17 adult diabetics (9 female; average age 55 (range: 27-74); 6 Caucasians, 11 African Americans; 15 NIDDM; 15 phakic, 2 pseudophakic) with PDR and no previous PRP. At baseline, average visual acuity (VA) was 76 letters (20/32) (range: 43-89) and average OCT CSF was 279 um (range: 203-445). At baseline, all eyes demonstrated active PDR and 4 eyes demonstrated diabetic macular edema (DME) (OCT CSF>300 um). At baseline, 9, 8 and 6 eyes demonstrated PDR with high risk characteristics (HRC), PDR without HRC, and mild vitreous hemorrhage or preretinal hemorrhage, respectively.Through 52 weeks, 17 eyes received an average of 5.7 injections (range: 1-10); 3 eyes received 4 injections for DME, alone. At 52 weeks, average VA was 80 letters (20/25) with an average gain of 5 letters (range: -15 to +25) and average OCT CSF was 261 um with an average thinning of -18 um (range: -155 to +18 um). Through 52 weeks, PDR progression was observed in 10 eyes. At 52 weeks, 0 eyes demonstrated OCT CSF>300 um. Ocular adverse events through 52 weeks included 3 eyes with progression or new VH, 1 eye with new DME, 1 eye with 30 letters loss and 0 eyes needing vitrectomy or PRP for PDR complications. Endophthalmitis, progression of traction or new rhegmatogenous retinal detachment were not observed.
Conclusions :
Optos wide-field fluorescein angiographic monitoring of neovascularization helps guide clinicians to optimally assess PDR status and may lead to optimal aflibercept monotherapy dosing with excellent visual acuity, OCT and safety outcomes for PDR eyes.
This abstract was presented at the 2019 ARVO Annual Meeting, held in Vancouver, Canada, April 28 - May 2, 2019.