Recruiting

Phase 2

Phase 3

Tiespectus vs. AfliberceptA Clinical Trial of EYE201/MK-8748 in People With Macular Degeneration (MK-8748-003)

Sponsor:

EyeBiotech Ltd.

Code:

NCT07496567

Conditions

Macular Degeneration

Age-Related Macular Degeneration

Choroidal Neovascularization

Wet Macular Degeneration

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Interventions

Tiespectus

Aflibercept

Study Details

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

Age-Related Macular Degeneration

Choroidal Neovascularization

Wet Macular Degeneration

Study ID

NCT07496567

Start date

Apr 15, 2026

Status verified date

Aug, 2026

Completion date

Jul 31, 2028

Anticipated

Primary completion date

Jul 31, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

960 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Tiespectus Low Dose

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.

experimental: Tiespectus High Dose

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

active comparator: Aflibercept 2 mg

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

Interventions

Tiespectus

Administered by intravitreal (IVT) injection

Aflibercept

Administered by intravitreal (IVT) injection

Primary outcome measure

Mean Change in Best-Corrected Visual Acuity (BCVA) [Early Treatment of Diabetic Retinopathy Study (ETDRS Letters)] From Baseline to Year 1 [ Time Frame: Baseline and Year 1 ]

Central Contacts and Locations

Central contacts

Toll Free Number

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

Locations

Associated Retina Consultants - Gilbert

Recruiting

Gilbert, Arizona, United States, 85259

Contacts

Study Coordinator

602-242-4928

The Retina Partners

Recruiting

Encino, California, United States, 91436

Contacts

Jesus Vargas

818-788-9333 jesusv@theretinapartners.com

Principal Investigator:

Amir Guerami

Northern California Retina Vitreous Associates Medical Group, Inc.

Recruiting

Mountain View, California, United States, 94040

Contacts

Study Coordinator

650-963-3465

Orange County Retina Medical Group

Recruiting

Santa Ana, California, United States, 92705

Contacts

Study Coordinator

714-972-8432

Retina Consultants of Southern Colorado

Recruiting

Colorado Springs, Colorado, United States, 80909

Contacts

Study Coordinator

719-473-9595

RSC Research LLC

Recruiting

Denver, Colorado, United States, 80222

Contacts

Study Coordinator

720-443-2425

Retina Consultants of Southern Colorado

Recruiting

Pueblo, Colorado, United States, 81008

Contacts

Study Coordinator

719-473-9595

Connecticut Eye Consultants, P.C.

Recruiting

Danbury, Connecticut, United States, 06810

Contacts

Study Coordinator

203-791-2020

Retina Consultants, P.C.

Recruiting

Manchester, Connecticut, United States, 06042

Contacts

Study Coordinator

860-646-7704

Retina Group of New England

Recruiting

Waterford, Connecticut, United States, 06385

Contacts

Study Coordinator

860-444-1292

Retina Group of Florida

Recruiting

Fort Myers, Florida, United States, 33912

Contacts

Study Coordinator

239-938-1284

Florida Retina Institute

Recruiting

Orlando, Florida, United States, 32806

Contacts

Study Coordinator

407-849-9621

Retina Group of Florida (Site 065)

Recruiting

Sarasota, Florida, United States, 34232

Contacts

Study Coordinator

941-924-0303

Center for Retina and Macular Disease (Site 062)

Recruiting

Winter Haven, Florida, United States, 33880

Contacts

Study Coordinator

863-297-5400

Illinois Retina Associates

Recruiting

Joliet, Illinois, United States, 60435

Contacts

Study Coordinator

815-744-7515

University Retina & Macula Associates, P.C.

Recruiting

Lemont, Illinois, United States, 60439

Contacts

Study Coordinator

708-765-4110

Wolfe Eye Clinic

Recruiting

West Des Moines, Iowa, United States, 50266

Contacts

Study Coordinator

515-223-8686

Retina Associates, LLC

Recruiting

Lenexa, Kansas, United States, 66215

Contacts

Study Coordinator

913-831-7400

Butchertown Clinical Trials

Recruiting

Louisville, Kentucky, United States, 40206

Contacts

Study Coordinator

502-589-1500

Maine Eye Center (Site 097)

Recruiting

Portland, Maine, United States, 04101

Contacts

Study Coordinator

207-523-5548

Mid Atlantic Retina Specialists

Recruiting

Hagerstown, Maryland, United States, 21740

Contacts

Study Coordinator

301-671-2400

Retina Research Institute at New England Retina Consultants, PC

Recruiting

Springfield, Massachusetts, United States, 01107

Contacts

Study Coordinator

413-732-2333

Retina Consultants of Minnesota

Recruiting

Edina, Minnesota, United States, 55435

Contacts

Study Coordinator

952-259-6262

Envision Ocular, LLC

Recruiting

Bloomfield, New Jersey, United States, 07003

Contacts

Study Coordinator

973-707-5632

Long Island Vitreoretinal Consultants / Vitreoretinal Consultants of NY

Recruiting

Great Neck, New York, United States, 11021

Contacts

Study Coordinator

516-466-0390

Retina Associates of Western NY, PC (Site 051)

Recruiting

Rochester, New York, United States, 14620

Contacts

Study Coordinator

585-450-2082

Asheville Eye Associates, Retina Division (Site 077)

Recruiting

Asheville, North Carolina, United States, 28803

Contacts

Study Coordinator

828-255-8008

NC Retina

Recruiting

Cary, North Carolina, United States, 27511

Contacts

Amanda Smith

919-782-8038 asmith@ncretina.com

Principal Investigator:

Lekha Desai

Graystone Eye

Recruiting

Hickory, North Carolina, United States, 28602

Contacts

Study Coordinator

828-304-6643

NC Retina Associates

Recruiting

Wake Forest, North Carolina, United States, 27587

Contacts

Amanda Smith

919-782-8038 asmith@ncretina.com

Principal Investigator:

John Thordsen

Retina Consultants, LLC

Recruiting

Salem, Oregon, United States, 97302

Contacts

Study Coordinator

503-371-4350

Cascade Medical Research Institute, LLC

Recruiting

Springfield, Oregon, United States, 97477

Contacts

Study Coordinator

541-687-1927

Erie Retina Research

Recruiting

Erie, Pennsylvania, United States, 16505

Contacts

Study Coordinator

814-200-9152

Charleston Neuroscience Institute (Site 034)

Recruiting

Beaufort, South Carolina, United States, 29902

Contacts

Study Coordinator

843-763-4466

Palmetto Retina Center

Recruiting

Florence, South Carolina, United States, 29501

Contacts

Study Coordinator

803-931-0077

Charleston Neuroscience Institute

Recruiting

Ladson, South Carolina, United States, 29456

Contacts

Study Coordinator

843-763-4466

Palmetto Retina Center

Recruiting

West Columbia, South Carolina, United States, 29169

Contacts

Study Coordinator

803-744-0158

Southeastern Retina Associates

Recruiting

Hixson, Tennessee, United States, 37343

Contacts

KaSandra "Kassy" Schratter

423-756-1002 kschratter@seretina.com

Principal Investigator:

Devon Ghodasra

Southeastern Retina Associates (Site 095)

Recruiting

Johnson City, Tennessee, United States, 37604

Contacts

Study Coordinator

423-578-4364

Southeastern Retina Associates, P.C.

Recruiting

Knoxville, Tennessee, United States, 37922

Contacts

Study Coordinator

865-588-0811

Tennessee Retina

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Study Coordinator

615-983-6000

Retina Consultants of Texas

Recruiting

Bellaire, Texas, United States, 77401

Contacts

Study Coordinator

713-394-7576

Texas Retina Associates

Recruiting

Fort Worth, Texas, United States, 76104

Contacts

Study Coordinator

817-334-0882

Retina Consultants of Texas

Recruiting

Katy, Texas, United States, 77494

Contacts

Study Coordinator

713-524-3434

Austin Retina Associates

Recruiting

Round Rock, Texas, United States, 78681

Contacts

Study Coordinator

800-252-8259

Retina Consultants of Texas

Recruiting

San Antonio, Texas, United States, 78240

Contacts

Study Coordinator

210-903-1046

Austin Retina Associates

Recruiting

San Marcos, Texas, United States, 78666

Contacts

Study Coordinator

512-451-0103

Retina Consultants of Texas

Recruiting

Schertz, Texas, United States, 78154

Contacts

Study Coordinator

210-693-1063

Salt Lake Retina

Recruiting

West Jordan, Utah, United States, 84088

Contacts

Study Coordinator

801-679-4173

Vistar Eye Center (Site 129)

Recruiting

Roanoke, Virginia, United States, 24019

Contacts

Study Coordinator

540-342-3400

Pacific Northwest Retina

Recruiting

Bellevue, Washington, United States, 98004

Contacts

Study Coordinator

206-215-3850

Northeast Wisconsin Retina Associates

Recruiting

Appleton, Wisconsin, United States, 54914

Contacts

Study Coordinator

920-751-8666

More Information

Sponsor

EyeBiotech Ltd.

Last update posted

Aug 6, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-08. This information was provided to ClinicalTrials.gov by EyeBiotech Ltd. on 2026-08-06. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.