Randomized, Double-Masked, Multicenter Phase 2/3 Trial of Intravitreal MK-8748 Versus Aflibercept in Patients with Neovascular Age‑Related Macular Degeneration

The primary objective is to demonstrate that intravitreal EYE201/MK-8748 is non‑inferior to aflibercept (2 mg) with respect to the mean change in best‑corrected visual acuity (ETDRS letters) from baseline to one year in participants with neovascular age‑related macular degeneration. This endpoint evaluates the therapeutic efficacy of the investigational agent relative to an established anti‑VEGF treatment, addressing the clinical imperative of preserving visual function in this disease.

The trial enrolled 715 participants, comprising both female and male individuals, with an age range defined by the study’s internal coding system. All subjects had a confirmed diagnosis of neovascular age‑related macular degeneration (NVAMD) made within 21 days prior to the first dose and were treatment‑naïve for choroidal neovascularization (CNV) secondary to AMD, including subfoveal, juxtafoveal, extrafoveal lesions, retinal angiomatous proliferations, or polypoidal choroidal vascularization in at least one eye. Eligibility required a documented decrease in visual acuity in the study eye attributable primarily to NVAMD. No additional lifestyle or health status criteria were specified in the provided information.

The study is a randomized, double‑masked, multicenter, three‑arm pivotal Phase 2/3 trial comparing intravitreal EYE201/MK‑8748 with intravitreal aflibercept 2 mg in participants diagnosed with neovascular age‑related macular degeneration (NVAMD). Eligible individuals are screened within 21 days of diagnosis, undergo a baseline visit for randomization and the first study injection, and then attend scheduled follow‑up visits for safety monitoring, imaging, and efficacy assessments, including measurement of best‑corrected visual acuity (BCVA) using ETDRS letters. The primary efficacy endpoint is the mean change in BCVA from baseline to Year 1, with an end‑of‑study visit at that time point; participants remain in the trial for at least one year of follow‑up. Randomization assigns participants to the test arm (MK‑8748), the comparator arm (aflibercept), or an auxiliary arm utilizing fluorescein for imaging. Early termination may occur if a participant experiences a serious adverse event, fails to meet protocol compliance, withdraws consent, or is lost to follow‑up. The overall trial recruitment commenced on 31 March 2026 and is projected to conclude on 30 August 2029.

The investigational product, designated EYE201/MK-8748, is supplied as a solution for intravitreal injection. The active ingredient is MK-8748. The preparation is presented in a single‑use vial (pharmaceutical form: SOLUTION FOR INTRAVITREAL INJECTION). The administered dose, as recorded in the study database, is 0 mg (dose unit: milligram). Administration is performed by intravitreal route according to the dosing schedule defined in the protocol, and each administration is documented by study personnel to ensure compliance monitoring.

The comparator arm receives aflibercept, a recombinant fusion protein supplied as a sterile solution (pharmaceutical form: PHF00231MIG) for intravitreal use. The dose is 2 mg (dose unit: milligram) per injection. The intravitreal route of administration follows the protocol‑specified schedule, and all injections are recorded in the study log to verify adherence.

Fluorescein sodium is employed as an auxiliary agent for retinal imaging. It is provided as a solution (pharmaceutical form: PHF00231MIG) with a concentration of 0 % (v/v). The agent is administered by a route classified as “other use” for diagnostic purposes, and its application is documented in the imaging records.

All study medications are administered under controlled conditions, with dosing times, volumes, and routes captured in the electronic case report form. Study staff conduct routine checks of the medication administration logs and maintain records of any deviations to support participant compliance monitoring throughout the trial.

The primary efficacy parameter is the mean change in best-corrected visual acuity (ETDRS letter score) from baseline to the end of Year 1. BCVA will be measured with the Early Treatment of Diabetic Retinopathy Study chart under standardized conditions at the baseline visit and again at the Year 1 visit. The primary analysis will compare the mean change between the investigational product and aflibercept to assess non‑inferiority.