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

NCT07440225 · tracked via the Priya Life Science USA tracker

Sponsor

EyeBiotech Ltd.

Phase

Phase 2/3

Started

2026-03-27

Last updated

2026-09-18

Condition(s) studied

Macular DegenerationAge-Related Macular DegenerationChoroidal NeovascularizationWet Macular Degeneration

Investigational drug(s) / intervention(s)

TiespectusAflibercept

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

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 (124)

Facility	City	Region	Status
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
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
Tulsa Retina Consultants	Tulsa	Oklahoma	Recruiting

+ 84 more sites — see the full list on the official registry below.

More EyeBiotech Ltd. trials in the USA

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 Dose-masked Study of Intravitreal EYE103 in Participants With NVAMD or Macular Edema Following BRVO Recruiting

A Study 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

A Phase I, Open-label, Multicenter, Dose-Escalating Study to Evaluate the Safety and Tolerability of KH658 Gene Therapy in Participants With Neovascular Age-related Macular Degeneration Active, not recruiting

An Observational Study of the Progression of Intermediate Age-Related Macular Degeneration Active, not recruiting

Feasibility and Safety of MB-102 in Ocular Angiography as Compared to Fluorescein Sodium Recruiting

A Study to Learn How Avacincaptad Pegol (Izervay™) is Used in Clinical Practice in People Who Have Geographic Atrophy Recruiting

Safety and Tolerability of KH631 Gene Therapy in Participants With Neovascular 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 the USA