Study Design for ELARA, a Phase 3b Trial of Aflibercept 8 mg in Previously Treated Patients With Neovascular Age-Related Macular Degeneration or Diabetic Macular Edema.

introductionAflibercept 8 mg at extended dosing intervals demonstrated functional and anatomic improvements in a large majority of patients with neovascular age-related macular degeneration (nAMD) or diabetic macular edema (DME) in pivotal trials. Although a subset of patients may require frequent injections to maintain disease control, the efficacy and safety of monthly dosing with aflibercept 8 mg had not been extensively assessed. The ELARA trial evaluated the tolerability and measures of efficacy of aflibercept 8 mg every 4 weeks, as well as the feasibility of dosing interval extension following 6 monthly doses of aflibercept 8 mg, in previously treated patients with nAMD or DME.

methodsELARA was a multicenter, open-label, 96-week, phase 3b trial. Previously treated patients with nAMD or DME who received ≥ 3 intravitreal anti-vascular endothelial growth factor injections within 5 months before the first trial visit were eligible to participate. Patients received monthly injections of aflibercept 8 mg through week 24. Beginning at week 24, a treat-and-extend regimen was implemented based on dose regimen modification (DRM) criteria assessing disease activity and response to treatment to reflect treatment patterns of retina specialists in clinical practice. Dosing intervals were modified in patients who met DRM criteria for extension or shortening from week 24 through 96. The minimum dosing interval was every 4 weeks. PLANNED OUTCOMES: The primary outcome was the incidence of ocular and non-ocular treatment-emergent adverse events through week 24. Exploratory outcomes included the change from baseline in best-corrected visual acuity and central subfield thickness at weeks 24 and 96.

trial registrationNCT06491914.