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Comparing tiespectus (MK-8748) with aflibercept for wet age-related macular degeneration

A Randomized Double-masked, Multicenter, 3-arm, Pivotal Phase 2/3 Study to Evaluate the Efficacy and Safety of Intravitreal (IVT) EYE201/MK-8748 Compared to Aflibercept (2 mg) in Participants With Neovascular Age-related Macular Degeneration (NVAMD)

Phase2; Phase3 Interventional EyeBiotech Ltd. · NCT07440225

This study will test whether tiespectus (MK-8748) works as well as aflibercept for people with newly diagnosed neovascular (wet) age-related macular degeneration.

Quick facts

PhasePhase2; Phase3
Study typeInterventional
Enrollment960 (estimated)
Ages50 Years and up
SexAll
SponsorEyeBiotech Ltd. Industry-sponsored
Locations30 sites (Springdale, Arkansas and 29 other locations)
Trial IDNCT07440225 on ClinicalTrials.gov

What this trial studies

This randomized Phase 2/3 trial enrolls treatment‑naive patients with choroidal neovascularization secondary to AMD and randomizes them to receive intravitreal tiespectus (MK-8748) or aflibercept. Eligible participants must have a diagnosis of neovascular AMD made within 21 days before starting treatment. Patients will receive regular in‑office eye injections and follow-up visits with vision testing and retinal imaging to track response. The trial is being run at several retina clinics in the United States.

Who should consider this trial

Good fit: Ideal candidates are adults with newly diagnosed, treatment‑naive choroidal neovascularization due to AMD (including subfoveal, juxtafoveal, extrafoveal, RAP, or PCV lesions) with diagnosis made within 21 days of starting treatment.

Not a fit: Patients with uncontrolled blood pressure, uncontrolled glaucoma, recent cataract or certain eye surgeries within 90 days, prior macular laser in the study eye, a history of uveitis, or other active retinal diseases are excluded and may not benefit from participation.

Why it matters

Potential benefit: If successful, tiespectus could offer an alternative intravitreal treatment that preserves or improves vision comparable to aflibercept and may help patients who do not respond to current therapy.

How similar studies have performed: Approved anti‑VEGF drugs like aflibercept, ranibizumab, and bevacizumab have proven effective for wet AMD, while tiespectus (MK-8748) is an investigational agent with limited prior clinical data.

Eligibility criteria

Show full inclusion / exclusion criteria 
The main inclusion criteria include but are not limited to the following:

* Has treatment naive choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) including subfoveal, juxtafoveal and extrafoveal lesions or retinal angiomatous proliferations (RAP) and polypoidal choroidal vascularization (PCV) lesions in at least one eye (study eye)
* The diagnosis of neovascular age-related macular degeneration (NVAMD) must have been made within 21 days prior to starting study treatment

The main exclusion criteria include but are not limited to the following

* Has uncontrolled blood pressure at screening
* History of any prior macular laser photocoagulation in the study eye
* History of uveitis in either eye
* History of cataract surgery, minimally invasive glaucoma surgery, or Yttrium-Aluminium Garnet (Yag) laser capsulotomy in the study eye within 90 days before entering the study
* Has uncontrolled glaucoma in the study eye
* Active retinal disease other than the condition under investigation in the study eye
* Has previously received anti- vascular endothelial growth factor (VEGF) therapy or other intravitreal (IVT) therapy in the study eye

Where this trial is running

Springdale, Arkansas and 29 other locations

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Macular DegenerationAge-Related Macular DegenerationChoroidal NeovascularizationWet Macular Degeneration
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.