Four-week Aflibercept Regimen Beneficial In Macular Edema After Vitrectomy

It is a minor paradox — epiretinal membrane that occurs with diabetic macular edema (DME) is among the top reasons for pars plana vitrectomy (PPV), but after the procedure, intravitreal medicines to treat persistent DME may dissipate more rapidly in the absence of vitreous. In the first study to evaluate intravitreal aflibercept injections (IAI) for human eyes with DME following vitrectomy, treatment scheduled closer than 8 weeks apart during the first year was shown to benefit vision, according to the analysis published in Clinical Ophthalmology.

The prospective investigation, MODEVA (ClinicalTrials.gov Identifier: NCT02874859), observed 46 eyes of 44 adult patients with resistant DME who underwent vitrectomy at least 3 months before their first study visit. Participants 18 years and older were recruited for the research, launched in November 2016, and conducted at 8 ophthalmology clinics in France. Requirements included HbA1c lower than 9%, visual acuity of 20/400 to 20/40, and no DME treatment for 3 months prior to starting aflibercept. Patients received 5 IAIs (2 mg/0.05 mL), 1 every 4 weeks, followed by pro re nata therapy.

At baseline, mean Early Treatment Diabetic Retinopathy Study (ETDRS) score was 53.5 letters. The study shows that 8 individuals were lost to follow-up or medication change by the sixth month of the study. For the 36 remaining eyes, mean acuity improved by +4.6 ETDRS letters after 5 injections by month 6 (P =.002), and +6.0 letters by the end of year 1 (P <.001). Of these, 6 eyes gained more than 15 letters, 26 were stable and lost fewer than 15 letters, and 1 eye lost at least15 letters. Patients regained vision regardless of baseline VA, HbA1c, duration of DME, or age.

Mean central subfield thickness (CST) was 430 µm at baseline. CST was reduced by 15%, -65 µm (P <.001) by month 6, and by 25%, -108 µm at the end of year 1 (P <.001). Further, baseline mean macular volume of 10.1 mm was down -0.9 mm at month 6 (P <.001), and -1.0 mm at year 1 (P =.001). Instances of subretinal fluid resolved in all patients — intraretinal cysts persisted in 59% of eyes. No remarkable adverse events were reported, except 2 routine cataract surgeries.

For 34 eyes that completed the 1-year period, the mean number of IAI was 9.3, with the mean interval between injections 5.8 weeks. The shorter time between IAIs may have been due to “the increase (in) clearance of the drug post vitrectomy,” prompting the need to increase frequency of treatment.

Median age of this sample was 67.5 years. The research did not include a control group, which is a limitation of the study. Also, patients occasionally missed a visit, and 12 eyes eventually dropped out. Strengths of the analysis were homogenous therapy and a second year of follow-up.

Previous clinical trials of anti-VEGF drugs examined eyes with vitreous, and studies of vitrectomized eyes have reported on therapy with medicines such as ranibizumab. “VA response to aflibercept at 12 weeks was correlated with 1 year response in VA in our study,” according to the report. “This individual variability in the course of vision gain as in DME treated with anti-VEGF drugs and early response may predict the visual outcome.”

Disclosures: Several study authors declared affiliations with biotech and pharmaceutical companies. Please see the original reference for a full list of authors’ disclosures.

Reference

Tran THC, Erginay A, Verdun S, et al. One-year outcome of aflibercept intravitreal injection in vitrectomized eyes with diabetic macular edema. Clin Ophthal. 2021;15:1971-1978. doi:10.2147/OPTH.S304030