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Clinical Trials in Spain / NCT07496567
Recruiting Phase 2/3

A Clinical Trial of EYE201/MK-8748 in People With Macular Degeneration (MK-8748-003)

NCT07496567 · tracked via the Priya Life Science Spain tracker
Sponsor
EyeBiotech Ltd
Phase
Phase 2/3
Started
2026-04-15
Last updated
2026-08-06

Condition(s) studied

Macular DegenerationAge-Related Macular DegenerationChoroidal NeovascularizationWet Macular Degeneration

Investigational drug(s) / intervention(s)

Tiespectus →Aflibercept →

Tiespectus: Administered by intravitreal (IVT) injection

Aflibercept: Administered by intravitreal (IVT) injection

Study summary

Researchers are looking for new ways to treat neovascular age-related macular degeneration (NVAMD).

Available standard (usual) treatments for NVAMD, such as aflibercept, may not work for every person. Researchers want to learn if a trial medicine called tiespectus (also called MK-8748 or EYE201) can treat NVAMD.

The goal of this trial is to learn if tiespectus works as well as aflibercept to treat NVAMD.

Eligibility

Sex
ALL
Min age
50 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Mean Change in Best-Corrected Visual Acuity (BCVA) [Early Treatment of Diabetic Retinopathy Study (ETDRS Letters)] From Baseline to Year 1 — Baseline and Year 1
    Participants' BCVA in the study eye will be measured using the Early Treatment of Diabetic Retinopathy (ETDRS) methodology. The ETDRS letter score ranges from 0 to 100, with a higher score indicating better visual acuity. Mean change in ETDRS letters from baseline to Year 1 will be assessed.

Trial sites (71)

FacilityCityRegionStatus
Associated Retina Consultants - Gilbert Gilbert Arizona Recruiting
The Retina Partners Encino California Recruiting
Northern California Retina Vitreous Associates Medical Group, Inc. Mountain View California Recruiting
Orange County Retina Medical Group Santa Ana California Recruiting
Retina Consultants of Southern Colorado Colorado Springs Colorado Recruiting
RSC Research LLC Denver Colorado Recruiting
Retina Consultants of Southern Colorado Pueblo Colorado Recruiting
Connecticut Eye Consultants, P.C. Danbury Connecticut Recruiting
Retina Consultants, P.C. Manchester Connecticut Recruiting
Retina Group of New England Waterford Connecticut Recruiting
Retina Group of Florida Fort Myers Florida Recruiting
Florida Retina Institute Orlando Florida Recruiting
Retina Group of Florida (Site 065) Sarasota Florida Recruiting
Center for Retina and Macular Disease (Site 062) Winter Haven Florida Recruiting
Illinois Retina Associates Joliet Illinois Recruiting
University Retina & Macula Associates, P.C. Lemont Illinois Recruiting
Wolfe Eye Clinic West Des Moines Iowa Recruiting
Retina Associates, LLC Lenexa Kansas Recruiting
Butchertown Clinical Trials Louisville Kentucky Recruiting
Maine Eye Center (Site 097) Portland Maine Recruiting
Mid Atlantic Retina Specialists Hagerstown Maryland Recruiting
Retina Research Institute at New England Retina Consultants, PC Springfield Massachusetts Recruiting
Retina Consultants of Minnesota Edina Minnesota Recruiting
Envision Ocular, LLC Bloomfield New Jersey Recruiting
Long Island Vitreoretinal Consultants / Vitreoretinal Consultants of NY Great Neck New York Recruiting
Retina Associates of Western NY, PC (Site 051) Rochester New York Recruiting
Asheville Eye Associates, Retina Division (Site 077) Asheville North Carolina Recruiting
NC Retina Cary North Carolina Recruiting
Graystone Eye Hickory North Carolina Recruiting
NC Retina Associates Wake Forest North Carolina Recruiting
Retina Consultants, LLC Salem Oregon Recruiting
Cascade Medical Research Institute, LLC Springfield Oregon Recruiting
Erie Retina Research Erie Pennsylvania Recruiting
Charleston Neuroscience Institute (Site 034) Beaufort South Carolina Recruiting
Palmetto Retina Center Florence South Carolina Recruiting
Charleston Neuroscience Institute Ladson South Carolina Recruiting
Palmetto Retina Center West Columbia South Carolina Recruiting
Southeastern Retina Associates Hixson Tennessee Recruiting
Southeastern Retina Associates (Site 095) Johnson City Tennessee Recruiting
Southeastern Retina Associates, P.C. Knoxville Tennessee Recruiting

+ 31 more sites — see the full list on the official registry below.

More EyeBiotech Ltd. trials in Spain

A Study to Evaluate the Efficacy and Safety of 2 Doses of EYE103 Compared With Ranibizumab (0.5 mg) in Participants With DME Active, not recruiting
A Clinical Trial of EYE201/MK-8748 in People With Macular Degeneration (MK-8748-002) Recruiting

Other trials for the same condition

Implementation of the Intravitreal Injection Administered by Nurses Enrolling by invitation
A Long-term Extension Study of JNJ-81201887 (AAVCAGsCD59) Parent Studies in Participants With Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD) Recruiting
Personalised Monitoring of Early and Intermediate Age-related Macular Degeneration With Artificial Intelligence and Identification of Disease Progression Recruiting
Personalized Monitoring of Non-foveal, Non-vision Compromising Atrophic Age-related Macular Degeneration With Artificial Intelligence and Identification of Disease Progression Recruiting
Post-market Clinical Investigation of the SING IMT System, Model NG SI IMT 3X in Patients With End-stage Age-related Macular Degeneration Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07496567 on ClinicalTrials.gov ↗ ← All trials in Spain