Dexamethasone implant and aflibercept combination therapy versus aflibercept monotherapy for diabetic macular edema: A prospective, comparative trial (COED trial)
04/2026
Journal Article
Authors:
Kim, I. P.;
Orndahl, C.;
Nyaiburi, C.;
Anand, R.;
Callanan, D.;
Chong, D.;
Coors, L.;
Fuller, T.;
McClellan, A.;
Solley, W.;
Wang, R.;
Williams, P.;
Yonekawa, Y.;
Abbey, A. M.
Journal:
Retina
PMID:
41954487
URL:
https://www.ncbi.nlm.nih.gov/pubmed/41954487
DOI:
10.1097/IAE.0000000000004858
Keywords:
Aflibercept Bcva Cst Dexamethasone Diabetic macular edema anti-VEGF intravitreal injection
Abstract:
PURPOSE: To compare combined dexamethasone implant (DEX) and intravitreal aflibercept (AFB) to AFB monotherapy treatment in diabetic macular edema (DME). METHODS: This open-label RCT involved randomization of DME patients (n=50) to pro re nata treatment with combined DEX and AFB or AFB alone according to pre-specified retreatment criteria. Best-corrected visual acuity (BCVA), 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% CI) in the change from baseline in CST between the groups was -32.9 (-81.5, 15.6) microm at week 48, favoring the combination therapy group without significance (p=0.183). The difference in the change from baseline in BCVA was -3.3 (-9.2, 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 (IRR [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 IOP 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 IOP risks.