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

NCT07496567 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 8748-003MK-8748-003
• Study Type: interventional
• Target: 960
• Locations: 8 countries
• Sites: 63

Brief 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.

Conditions

Macular Degeneration; Choroidal Neovascularization; Age-Related Macular Degeneration; Wet Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• Mean Change in Best-Corrected Visual Acuity (BCVA) [Early Treatment of Diabetic Retinopathy Study (ETDRS Letters)] From Baseline to 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.

  Baseline and Year 1

Secondary Outcomes (10)

• Mean Change in BCVA (ETDRS Letters) From Baseline (Day 1) Over Time to Year 1

  Up to Year 1

• Proportion of Participants Who Gain ≥5 ETDRS Letters at Year 1

  Year 1

• Proportion of Participants Who Gain ≥10 ETDRS Letters at Year 1

  Year 1

• Proportion of Participants Who Gain ≥15 ETDRS Letters at Year 1

  Year 1

• Proportion of Participants Who Lose ≥5 ETDRS Letters at Year 1

  Year 1

Study Arms (3)

Tiespectus Low Dose

EXPERIMENTAL

Participants receive 3 initial administrations of tiespectus low dose every 4 weeks (Q4W), then continue to receive tiespectus low dose every 8weeks (Q8W) until week 48. After week48, participants will be treated at intervals determined based on individualized response to treatment, up to week 92.

Drug: Tiespectus

Tiespectus High Dose

EXPERIMENTAL

Participants receive 3 initial administrations of tiespectus high dose Q4W, then continue to receive tiespectus high dose Q8W until week48. After week 48, participants will be treated at intervals determined based on individualized response to treatment, up to week 92

Drug: Tiespectus

Aflibercept 2 mg

ACTIVE COMPARATOR

Participants receive 3 initial administrations of aflibercept, then continue to receive aflibercept Q8W until week 92

Drug: Aflibercept

Interventions

Tiespectus DRUG

Administered by intravitreal (IVT) injection

Also known as: EYE201, MK-8748

Tiespectus High Dose; Tiespectus Low Dose

Aflibercept DRUG

Administered by intravitreal (IVT) injection

Also known as: Eylea®

Aflibercept 2 mg

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• EyeBiotech Ltd.: lead

Study Sites (63)

Associated Retina Consultants - Gilbert

Gilbert, Arizona, 85259, United States

RECRUITING

The Retina Partners

Encino, California, 91436, United States

RECRUITING

Northern California Retina Vitreous Associates Medical Group, Inc.

Mountain View, California, 94040, United States

RECRUITING

Retina Consultants of Southern Colorado

Colorado Springs, Colorado, 80909, United States

RECRUITING

RSC Research LLC

Denver, Colorado, 80222, United States

RECRUITING

Retina Consultants of Southern Colorado

Pueblo, Colorado, 81008, United States

RECRUITING

Connecticut Eye Consultants, P.C.

Danbury, Connecticut, 06810, United States

RECRUITING

Retina Consultants, P.C.

Manchester, Connecticut, 06042, United States

RECRUITING

Retina Group of New England

Waterford, Connecticut, 06385, United States

RECRUITING

Retina Group of Florida

Fort Myers, Florida, 33912, United States

RECRUITING

Florida Retina Institute

Orlando, Florida, 32806, United States

RECRUITING

Retina Group of Florida (Site 065)

Sarasota, Florida, 34232, United States

RECRUITING

Center for Retina and Macular Disease (Site 062)

Winter Haven, Florida, 33880, United States

RECRUITING

Illinois Retina Associates

Joliet, Illinois, 60435, United States

RECRUITING

University Retina & Macula Associates, P.C.

Lemont, Illinois, 60439, United States

RECRUITING

Wolfe Eye Clinic

West Des Moines, Iowa, 50266, United States

RECRUITING

Retina Associates, LLC

Lenexa, Kansas, 66215, United States

RECRUITING

Butchertown Clinical Trials

Louisville, Kentucky, 40206, United States

RECRUITING

Maine Eye Center (Site 097)

Portland, Maine, 04101, United States

RECRUITING

Mid Atlantic Retina Specialists

Hagerstown, Maryland, 21740, United States

RECRUITING

Retina Research Institute at New England Retina Consultants, PC

Springfield, Massachusetts, 01107, United States

RECRUITING

Retina Consultants of Minnesota

Edina, Minnesota, 55435, United States

RECRUITING

Envision Ocular, LLC

Bloomfield, New Jersey, 07003, United States

RECRUITING

Long Island Vitreoretinal Consultants / Vitreoretinal Consultants of NY

Great Neck, New York, 11021, United States

RECRUITING

Retina Associates of Western NY, PC (Site 051)

Rochester, New York, 14620, United States

RECRUITING

Asheville Eye Associates, Retina Division (Site 077)

Asheville, North Carolina, 28803, United States

RECRUITING

NC Retina

Cary, North Carolina, 27511, United States

RECRUITING

Graystone Eye

Hickory, North Carolina, 28602, United States

RECRUITING

NC Retina Associates

Wake Forest, North Carolina, 27587, United States

RECRUITING

Retina Consultants, LLC

Salem, Oregon, 97302, United States

RECRUITING

Cascade Medical Research Institute, LLC

Springfield, Oregon, 97477, United States

RECRUITING

Erie Retina Research

Erie, Pennsylvania, 16505, United States

RECRUITING

Charleston Neuroscience Institute (Site 034)

Beaufort, South Carolina, 29902, United States

RECRUITING

Palmetto Retina Center

Florence, South Carolina, 29501, United States

RECRUITING

Charleston Neuroscience Institute

Ladson, South Carolina, 29456, United States

RECRUITING

Palmetto Retina Center

West Columbia, South Carolina, 29169, United States

RECRUITING

Southeastern Retina Associates

Hixson, Tennessee, 37343, United States

RECRUITING

Southeastern Retina Associates (Site 095)

Johnson City, Tennessee, 37604, United States

RECRUITING

Southeastern Retina Associates, P.C.

Knoxville, Tennessee, 37922, United States

RECRUITING

Tennessee Retina

Nashville, Tennessee, 37203, United States

RECRUITING

Retina Consultants of Texas

Bellaire, Texas, 77401, United States

RECRUITING

Texas Retina Associates

Fort Worth, Texas, 76104, United States

RECRUITING

Retina Consultants of Texas

Katy, Texas, 77494, United States

RECRUITING

Austin Retina Associates

Round Rock, Texas, 78681, United States

RECRUITING

Retina Consultants of Texas

San Antonio, Texas, 78240, United States

RECRUITING

Austin Retina Associates

San Marcos, Texas, 78666, United States

RECRUITING

Retina Consultants of Texas

Schertz, Texas, 78154, United States

RECRUITING

Salt Lake Retina

West Jordan, Utah, 84088, United States

RECRUITING

Vistar Eye Center (Site 129)

Roanoke, Virginia, 24019, United States

RECRUITING

Pacific Northwest Retina

Bellevue, Washington, 98004, United States

RECRUITING

IPEPO - Instituto Paulista de Estudos e Pesquisas em Oftalmologia (Site 332)

São Paulo, 04038-032, Brazil

RECRUITING

Clinica Oftalmologica del Caribe (COFCA)

Barranquilla, 080001 - Atlantico, Colombia

RECRUITING

Fundacion Oftalmologica Nacional

Bogotá, 110231 - D.C., Colombia

RECRUITING

Clinica de Oftalmologia Sandiego

Medellín, 050021 - Antioquia, Colombia

RECRUITING

Klaudians Hospital - Ophthalmology department

Mladá Boleslav, 293 01, Czechia

RECRUITING

VISUS spol. s r.o.

Náchod, 54701, Czechia

RECRUITING

Axon Clinical, s.r.o. (Site 400)

Prague, 150 00, Czechia

RECRUITING

Astra Clinic.s.r.o.

Prague, 184 00, Czechia

RECRUITING

Hopital Intercommunal De Creteil

Créteil, 94010, France

RECRUITING

Budapest Retina Associates

Budapest, 1133, Hungary

RECRUITING

AIBILI Azinhaga de Santa Comba

Coimbra, 3000-548, Portugal

RECRUITING

Hospital General de Catalunya

Barcelona, 8195, Spain

RECRUITING

Oftalvist

Burjassot -(Valencia), 46100, Spain

RECRUITING

MeSH Terms

Conditions

Macular Degeneration; Choroidal Neovascularization; Wet Macular Degeneration

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases; Choroid Diseases; Uveal Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Central Study Contacts

Toll Free Number

CONTACT

1-888-577-8839; Trialsites@msd.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2026
• First Posted: March 27, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: July 24, 2026

Record last verified: 2026-07

Locations

US (50); CZ (4); BR (1); CO (3); FR (1); HU (1); ES (2); PT (1)