Recruiting
Phase 2
Phase 3

Tiespectus vs. Aflibercept

Sponsor:

EyeBiotech Ltd.

Code:

NCT07440225

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

NCT07440225

Start date

Mar 27, 2026

Status verified date

Sep, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Jun 30, 2028

Anticipated

Eligibility Criteria

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 8 weeks (Q8W) until week 48. After week 48, 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 week 48. 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 injection (IVT)

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

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

Locations

Research Network Arizona / Retina Macula Institute of Arizona

Recruiting

Scottsdale, Arizona, United States, 85255

Contacts

Study Coordinator

602-613-5473

Retina Center of Arkansas

Recruiting

Fayetteville, Arkansas, United States, 72703

Contacts

Study Coordinator

479-234-4499

Retina Partners of Northwest Arkansas, PLLC

Recruiting

Springdale, Arkansas, United States, 72764

Contacts

Study Coordinator

479-408-4470

Global Research Management, Inc.

Recruiting

Glendale, California, United States, 91204

Contacts

818-246-2560

Retinal Consultants Medical Group (Site 024)

Recruiting

Modesto, California, United States, 95356

Contacts

Study Coordinator

209-521-6173

Retina Consultants of Southern California (Site 043)

Recruiting

Redlands, California, United States, 92374

Contacts

Study Coordinator

951-788-0222

Retinal Consultants Medical Group (Site 020)

Recruiting

Sacramento, California, United States, 95825

Contacts

Study Coordinator

916-974-9279

Retinal Consultants Medical Group (Site 022)

Recruiting

Sacramento, California, United States, 95841

Contacts

Study Coordinator

916-339-3650

Florida Eye Clinic (Site 130)

Recruiting

Altamonte Springs, Florida, United States, 32701

Contacts

Study Coordinator

407-775-7495

Retina Group of Florida (Site 070)

Recruiting

Fort Lauderdale, Florida, United States, 33308

Contacts

Study Coordinator

954-776-6880

Vitreo Retinal Associates

Recruiting

Gainesville, Florida, United States, 32607

Contacts

352-300-8412

Florida Retina Institute

Recruiting

Jacksonville, Florida, United States, 32216

Contacts

Study Coordinator

206-338-0248

Florida Retina Consultants

Recruiting

Lakeland, Florida, United States, 33805

Contacts

Study Coordinator

863-682-7474

Retina Care Specialists

Recruiting

Palm Beach Gardens, Florida, United States, 33410

Contacts

Study Coordinator

561-408-0853

Fort Lauderdale Eye Institute (Site 042)

Recruiting

Plantation, Florida, United States, 33324

Contacts

Study Coordinator

954-635-2861

Retina Vitreous Associates of Florida (Site 049)

Recruiting

St. Petersburg, Florida, United States, 33711

Contacts

Study Coordinator

727-323-0077

Southern Vitreoretinal Associates

Recruiting

Tallahassee, Florida, United States, 32308

Contacts

Study Coordinator

850-942-6700

Retina Associates of Florida, LLC

Recruiting

Tampa, Florida, United States, 33609

Contacts

Study Coordinator

616-438-9395

Retina Vitreous Associates of Florida

Recruiting

Tampa, Florida, United States, 33617

Contacts

Study Coordinator

813-987-2000

Wildwood Clinical Research / Florida Retina Institute

Recruiting

Wildwood, Florida, United States, 34785

Contacts

Study Coordinator

407-473-5596

Illinois Retina Associates

Recruiting

Oak Park, Illinois, United States, 60304

Contacts

Study Coordinator

872-222-0139

Springfield Clinic

Recruiting

Springfield, Illinois, United States, 62703

Contacts

Study Coordinator

217-528-7541

Associated Vitreoretinal and Uveitis Consultants

Recruiting

Carmel, Indiana, United States, 46032

Contacts

Study Coordinator

317-571-1501

Midwest Eye Institute

Recruiting

Carmel, Indiana, United States, 46032

Contacts

Study Coordinator

317-805-2152

Cumberland Valley Retina Consultants (Site 007)

Recruiting

Hagerstown, Maryland, United States, 21740

Contacts

Study Coordinator

301-665-1712

Foundation for Vision Research (Site 073)

Recruiting

Grand Rapids, Michigan, United States, 49546

Contacts

Study Coordinator

616-438-9395

Retina Consultants of Minnesota

Recruiting

Saint Louis Park, Minnesota, United States, 55416

Contacts

Study Coordinator

952-259-4285

Retina Specialists of Mississippi

Recruiting

Hattiesburg, Mississippi, United States, 39402

Contacts

Study Coordinator

601-255-0736

Mississippi Retina Associates (Site 084)

Recruiting

Madison, Mississippi, United States, 39110

Contacts

Study Coordinator

601-981-4091

Mid Atlantic Retina

Recruiting

Cherry Hill, New Jersey, United States, 08034

Contacts

Study Coordinator

215-928-3092

Vision Research Center Eye Associates of New Mexico

Recruiting

Albuquerque, New Mexico, United States, 87109

Contacts

Study Coordinator

505-393-7483

ong Island Vitreoretinal Consultants / Vitreoretinal Consultants of NY (Site 105)

Recruiting

Hauppauge, New York, United States, 11788

Contacts

Study Coordinator

516-466-0390

Retina Vitreous Surgeons of CNY, PC (Site 033)

Recruiting

Liverpool, New York, United States, 13088

Contacts

Study Coordinator

315-445-8166

Piedmont Retina Specialists - Greensboro

Recruiting

Greensboro, North Carolina, United States, 27401

Contacts

Study Coordinator

336-369-7160

North Carolina Retina Associates

Recruiting

Greenville, North Carolina, United States, 27834

Contacts

Study Coordinator

919-782-8038

Piedmont Retina Specialists - Winston-Salem

Recruiting

Winston-Salem, North Carolina, United States, 27103

Contacts

Study Coordinator

336-397-9216

Cincinnati Eye Institute (Site 133)

Recruiting

Cincinnati, Ohio, United States, 45242

Contacts

Study Coordinator

513-569-3462

Retina Vitreous Center

Recruiting

Edmond, Oklahoma, United States, 73013

Contacts

Study Coordinator

405-607-6699

Tulsa Retina Consultants

Recruiting

Tulsa, Oklahoma, United States, 74114

Contacts

Study Coordinator

918-395-0872

Retina Northwest, PC

Recruiting

Portland, Oregon, United States, 97221

Contacts

Study Coordinator

971-865-2781

EyeHealth Northwest

Recruiting

Portland, Oregon, United States, 97225

Contacts

Study Coordinator

503-296-6484

Mid Atlantic Retina (Site 050)

Recruiting

Bethlehem, Pennsylvania, United States, 18017

Contacts

Study Coordinator

516-466-0390

Palmetto Retina Center

Recruiting

Aiken, South Carolina, United States, 29803

Contacts

Study Coordinator

803-867-7058

Charleston Neuroscience Institute - Bluffton (Site 124)

Recruiting

Bluffton, South Carolina, United States, 29910

Contacts

Study Coordinator

843-278-9938

Charleston Neuroscience Institute (Site 104)

Recruiting

Charleston, South Carolina, United States, 29414

Contacts

Study Coordinator

843-972-3857

Charleston Neuroscience Institute (CNI) d/b/a Retina Consultants of South Carolina

Recruiting

Mt. Pleasant, South Carolina, United States, 29464

Contacts

Study Coordinator

843-763-4466

Charles Retina Institute

Recruiting

Germantown, Tennessee, United States, 38138

Contacts

Study Coordinator

901-683-0399

Retina Research Institute of Texas (Site 010)

Recruiting

Abilene, Texas, United States, 79606

Contacts

Study Coordinator

325-690-4414

Southwest Retina Specialists

Recruiting

Amarillo, Texas, United States, 79106

Contacts

Study Coordinator

806-350-1113

Texas Retina Associates

Recruiting

Arlington, Texas, United States, 76012

Contacts

Study Coordinator

682-433-5453

Austin Research Center for Retina

Recruiting

Austin, Texas, United States, 78705

Contacts

Study Coordinator

512-454-5851

Austin Retina Associates (Site 012)

Recruiting

Austin, Texas, United States, 78705

Contacts

Study Coordinator

512-451-0103

Retina & Vitreous of Texas

Recruiting

Bellaire, Texas, United States, 77401

Contacts

Study Coordinator

281-249-9076

Texas Retina Associates

Recruiting

Dallas, Texas, United States, 75231

Contacts

Study Coordinator

800-695-6941

Texas Retina (Site 037)

Recruiting

Plano, Texas, United States, 75075

Contacts

Study Coordinator

469-560-0177

Retina Center of Texas

Recruiting

Southlake, Texas, United States, 76092

Contacts

Study Coordinator

817-865-6800

Retina Consultants of Texas (Site 014)

Recruiting

The Woodlands, Texas, United States, 77384

Contacts

Study Coordinator

713-524-3434

Strategic Clinical Research Group

Recruiting

Weatherford, Texas, United States, 76087

Contacts

Study Coordinator

682-703-4318

Retina Associates of Utah

Recruiting

Salt Lake City, Utah, United States, 84107

Contacts

Study Coordinator

801-312-2020

Piedmont Eye Center (Site 054)

Recruiting

Lynchburg, Virginia, United States, 24502

Contacts

Study Coordinator

434-947-3984

Pacific Northwest Retina (Site 112)

Recruiting

Burlington, Washington, United States, 98233

Contacts

Study Coordinator

360-205-5417

Spokane Eye Clinical Research (Site 075)

Recruiting

Spokane, Washington, United States, 99204

Contacts

Study Coordinator

509-990-9913

Retina Consultants, PLLC

Recruiting

Charleston, West Virginia, United States, 25301

Contacts

Study Coordinator

304-346-4400

Eye Clinic of Wisconsin

Recruiting

Wausau, Wisconsin, United States, 54403

Contacts

Study Coordinator

715-261-8500

More Information

Sponsor

EyeBiotech Ltd.

Last update posted

Sep 2, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-13. This information was provided to ClinicalTrials.gov by EyeBiotech Ltd. on 2026-09-02.