Monthly or Quarterly Aflibercept Injections Appropriate for PDR Patients Without DME

Ahmed Roshdy Alagorie, MD

Monthly injections of aflibercept could be the best course of treatment for patients with proliferative diabetic retinopathy (PDR) who do not suffer from diabetic macular edema (DME).

In findings presented at the American Society of Retina Specialists 2020 (ASRS 2020) Virtual Sessions, a team, led by Ahmed Roshdy Alagorie, MD, Doheny Eye Institute, examined wither intravitreal aflibercept could impact the severity of diabetic retinopathy in patients with proliferative diabetic retinopathy.

In the prospective, longitudinal, IRB approved multicenter clinical trial, the investigators examined 40 eyes from 40 patients with proliferative diabetic retinopathy without diabetic macular edema. Each participant was randomized into monthly and quarterly 2 mg aflibercept injection cohorts over the course of the 12 month study.

The mean age of the patients was 48.2 years old, with the mean duration of diabetes mellitus of 16.1 years and mean HbA1c was 9.42%.

Each patient underwent ultra-wide field fundus imaging, which included pseudocolor and fluorescein angiography at baseline using an Optos 200Tx device with pseudo color images repeated at follow-up.

The researchers evaluated the severity of retinopathy at baseline, month 6, and month 12 by certified reading center using the diabetic retinopathy severity scale, which were correlated with 25-item and 39-item Visual Function Questionnaire (VFQ) scores at baseline and month 12.

The investigators did not find a difference in mean VFQ-25 and VFQ-39 composite scores at month 12. They did, however, find that they significantly correlated with improvement in DRSS (r = 0.384, P = 0.039; r = 0.361, P = 0.046; respectively).

In particular, improvement in DRSS was not correlated with change in best corrected visual acuity (r = 0.118, P = 0.498).

The study results suggest that if anti-VEGF is being considered for patients with PDR without DME, monthly or quarterly injection regimens of aflibercept would be optimal.

“In this study of eyes with PDR without DME, monthly aflibercept injection was associated with greater regression of DRSS at month 6 compared to quarterly dosing, but this difference was not significant by month12,” the authors wrote. “The improvement in DRSS was associated with an improvement in VFQ composite score.”

In 2019, the US Food and Drug Administration (FDA) approved the Chemistry, Manufacturing and Controls (CMC) Prior-Approval Supplement (PAS) for the EYLEA (aflibercept) Injection prefilled syringe to treat 4 retinal conditions.

The approval is for a 2 mg, single-dose, sterilized prefilled syringe produced by Regeneron Pharmaceuticals that enables physicians to administer aflibercept with fewer preparation steps than vials.

Intravitreal injections have been associated with endophthalmitis and retinal detachments and acute increases in intraocular pressure has been seen within 60 minutes of intravitreal injection.

The treatment also comes with a potential risk of arterial thromboembolic events, such as a nonfatal stroke, nonfatal myocardial infarction, or vascular death.

The study, “Effect of Intravitreal Aflibercept on Diabetic Retinopathy Severity and Visual Function in Subjects with Proliferative Diabetic Retinopathy,” was published online by ASRS 2020.