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Clinical Trials in Spain / NCT07440225
Recruiting Phase 2/3

A Clinical Trial of EYE201/MK-8748 in People With Macular Degeneration (MK-8748-002)

NCT07440225 · tracked via the Priya Life Science Spain tracker
Sponsor
EyeBiotech Ltd
Phase
Phase 2/3
Started
2026-03-27
Last updated
2026-10-02

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 injection (IVT)

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 (132)

FacilityCityRegionStatus
Research Network Arizona / Retina Macula Institute of Arizona Scottsdale Arizona Recruiting
Retina Center of Arkansas Fayetteville Arkansas Recruiting
Retina Partners of Northwest Arkansas, PLLC Springdale Arkansas Recruiting
Global Research Management, Inc. Glendale California Recruiting
Retinal Consultants Medical Group (Site 024) Modesto California Recruiting
Azul Vision / California Eye Specialists Medical Group, Inc. Pasadena California Recruiting
Retina Consultants of Southern California (Site 043) Redlands California Recruiting
Retinal Consultants Medical Group (Site 020) Sacramento California Recruiting
Retinal Consultants Medical Group (Site 022) Sacramento California Recruiting
Florida Eye Clinic (Site 130) Altamonte Springs Florida Recruiting
Retina Group of Florida (Site 070) Fort Lauderdale Florida Recruiting
Vitreo Retinal Associates Gainesville Florida Recruiting
Florida Retina Institute Jacksonville Florida Recruiting
Florida Retina Consultants Lakeland Florida Recruiting
South Florida Retina Institute Miami Florida Recruiting
Retina Care Specialists Palm Beach Gardens Florida Recruiting
Fort Lauderdale Eye Institute (Site 042) Plantation Florida Recruiting
Retina Vitreous Associates of Florida (Site 049) St. Petersburg Florida Recruiting
Southern Vitreoretinal Associates Tallahassee Florida Recruiting
Retina Associates of Florida, LLC Tampa Florida Recruiting
Retina Vitreous Associates of Florida Tampa Florida Recruiting
Wildwood Clinical Research / Florida Retina Institute Wildwood Florida Recruiting
Illinois Retina Associates Oak Park Illinois Recruiting
Springfield Clinic Springfield Illinois Recruiting
Associated Vitreoretinal and Uveitis Consultants Carmel Indiana Recruiting
Midwest Eye Institute Carmel Indiana Recruiting
Cumberland Valley Retina Consultants (Site 007) Hagerstown Maryland Recruiting
Foundation for Vision Research (Site 073) Grand Rapids Michigan Recruiting
Retina Consultants of Minnesota Saint Louis Park Minnesota Recruiting
Retina Specialists of Mississippi Hattiesburg Mississippi Recruiting
Mississippi Retina Associates (Site 084) Madison Mississippi Recruiting
Mid Atlantic Retina Cherry Hill New Jersey Recruiting
Vision Research Center Eye Associates of New Mexico Albuquerque New Mexico Recruiting
ong Island Vitreoretinal Consultants / Vitreoretinal Consultants of NY (Site 105) Hauppauge New York Recruiting
Retina Vitreous Surgeons of CNY, PC (Site 033) Liverpool New York Recruiting
Piedmont Retina Specialists - Greensboro Greensboro North Carolina Recruiting
North Carolina Retina Associates Greenville North Carolina Recruiting
Piedmont Retina Specialists - Winston-Salem Winston-Salem North Carolina Recruiting
Cincinnati Eye Institute (Site 133) Cincinnati Ohio Recruiting
Retina Vitreous Center Edmond Oklahoma Recruiting

+ 92 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-8748-003) 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 NCT07440225 on ClinicalTrials.gov ↗ ← All trials in Spain