Dexamethasone Implant and Aflibercept Combination Therapy Versus Aflibercept Monotherapy for Diabetic Macular Edema: A Prospective, Comparative Trial (COED Trial)

Summary

DME Eylea+Ozurdex vs Eylea monotherapy: Combined Rx similar VA and anatomic outcomes with quicker DME resolution, BUT higher risk for cataract and increased IOP (COED Trial) — Prospective, RCT, 50 patients

Abstract

Purpose: To compare combined dexamethasone implant and intravitreal aflibercept (AFB) to AFB monotherapy treatment in diabetic macular edema (DME).

Methods: This open-label randomized clinical trial involved randomization of patients with DME (n = 50) to pro re nata treatment with combined dexamethasone and AFB or AFB alone according to prespecified retreatment criteria. Best-corrected visual acuity, central subfield retinal thickness (CST), and adverse events were monitored monthly for 48 weeks.

Results: The combined treatment and the AFB monotherapy group demonstrated CST reductions at each visit. The difference (95% confidence intervals [CI]) in the change from baseline in CST between the groups was -32.9 (-81.5 to 15.6) µ m at week 48, favoring the combination therapy group without significance ( P = 0.183). The difference in the change from baseline in best-corrected visual acuity was -3.3 (-9.2 to 2.5) letters read at week 48 ( P = 0.266). Injection number was numerically higher in the aflibercept monotherapy group (mean ± SD, 5.9 ± 1.8) than in the combination group (4.9 ± 1.5). The AFB monotherapy group had a 90% higher injection rate over the study period (incidence rate ratio [95% CI] = 1.9 [0.9-4.0]) without statistical significance ( P = 0.081). The combined treatment group achieved quicker time to resolution of DME (log-rank P -value = 0.013) by a median difference (95% CI) of 12 (0-24) weeks. Three eyes and two eyes in the combined therapy group developed worsening cataracts and intraocular pressure elevation requiring medical management, respectively.

Conclusion: Combined treatment achieved similar anatomic and visual outcomes compared with AFB monotherapy, with quicker DME resolution but higher cataract and intraocular pressure risks.