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

June 12, 2026 updated by: EyeBiotech Ltd.

A Randomized Double-masked, Multicenter, 3-arm, Pivotal Phase 2/3 Study to Evaluate the Efficacy and Safety of Intravitreal (IVT) EYE201/MK-8748 Compared to Aflibercept (2 mg) in Participants With Neovascular Age-related Macular Degeneration (NVAMD)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

960

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85255
        • Recruiting
        • Research Network Arizona / Retina Macula Institute of Arizona
        • Contact:
          • Study Coordinator
          • Phone Number: 602-613-5473
    • Arkansas
      • Springdale, Arkansas, United States, 72764
        • Recruiting
        • Retina Partners of Northwest Arkansas, PLLC
        • Contact:
          • Study Coordinator
          • Phone Number: 479-408-4470
    • California
      • Glendale, California, United States, 91204
        • Recruiting
        • Global Research Management, Inc.
        • Contact:
          • Phone Number: 818-246-2560
      • Modesto, California, United States, 95356
        • Recruiting
        • Retinal Consultants Medical Group (Site 024)
        • Contact:
          • Study Coordinator
          • Phone Number: 209-521-6173
      • Redlands, California, United States, 92374
        • Recruiting
        • Retina Consultants of Southern California (Site 043)
        • Contact:
          • Study Coordinator
          • Phone Number: 951-788-0222
      • Sacramento, California, United States, 95825
        • Recruiting
        • Retinal Consultants Medical Group (Site 020)
        • Contact:
          • Study Coordinator
          • Phone Number: 916-974-9279
      • Sacramento, California, United States, 95841
        • Recruiting
        • Retinal Consultants Medical Group (Site 022)
        • Contact:
          • Study Coordinator
          • Phone Number: 916-339-3650
    • Florida
      • Fort Lauderdale, Florida, United States, 33308
        • Recruiting
        • Retina Group of Florida (Site 070)
        • Contact:
          • Study Coordinator
          • Phone Number: 954-776-6880
      • Gainesville, Florida, United States, 32607
        • Recruiting
        • Vitreo Retinal Associates
        • Contact:
          • Phone Number: 352-300-8412
      • Plantation, Florida, United States, 33324
        • Recruiting
        • Fort Lauderdale Eye Institute (Site 042)
        • Contact:
          • Study Coordinator
          • Phone Number: 954-635-2861
      • St. Petersburg, Florida, United States, 33711
        • Recruiting
        • Retina Vitreous Associates of Florida (Site 049)
        • Contact:
          • Study Coordinator
          • Phone Number: 727-323-0077
      • Tampa, Florida, United States, 33609
        • Recruiting
        • Retina Associates of Florida, LLC
        • Contact:
          • Study Coordinator
          • Phone Number: 616-438-9395
      • Tampa, Florida, United States, 33617
        • Recruiting
        • Retina Vitreous Associates of Florida
        • Contact:
          • Study Coordinator
          • Phone Number: 813-987-2000
    • Illinois
      • Oak Park, Illinois, United States, 60304
        • Recruiting
        • Illinois Retina Associates
        • Contact:
          • Study Coordinator
          • Phone Number: 872-222-0139
    • Indiana
      • Carmel, Indiana, United States, 46032
        • Recruiting
        • Associated Vitreoretinal and Uveitis Consultants
        • Contact:
          • Study Coordinator
          • Phone Number: 317-571-1501
    • Maryland
      • Hagerstown, Maryland, United States, 21740
        • Recruiting
        • Cumberland Valley Retina Consultants (Site 007)
        • Contact:
          • Study Coordinator
          • Phone Number: 301-665-1712
    • Michigan
      • Grand Rapids, Michigan, United States, 49546
        • Recruiting
        • Foundation for Vision Research (Site 073)
        • Contact:
          • Study Coordinator
          • Phone Number: 616-438-9395
    • Mississippi
      • Madison, Mississippi, United States, 39110
        • Recruiting
        • Mississippi Retina Associates (Site 084)
        • Contact:
          • Study Coordinator
          • Phone Number: 601-981-4091
    • New York
      • Hauppauge, New York, United States, 11788
        • Recruiting
        • ong Island Vitreoretinal Consultants / Vitreoretinal Consultants of NY (Site 105)
        • Contact:
          • Study Coordinator
          • Phone Number: 516-466-0390
      • Liverpool, New York, United States, 13088
        • Recruiting
        • Retina Vitreous Surgeons of CNY, PC (Site 033)
        • Contact:
          • Study Coordinator
          • Phone Number: 315-445-8166
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
        • Recruiting
        • Piedmont Retina Specialists - Winston-Salem
        • Contact:
          • Study Coordinator
          • Phone Number: 336-397-9216
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74114
        • Recruiting
        • Tulsa Retina Consultants
        • Contact:
          • Study Coordinator
          • Phone Number: 918-395-0872
    • Oregon
      • Portland, Oregon, United States, 97225
        • Recruiting
        • EyeHealth Northwest
        • Contact:
          • Study Coordinator
          • Phone Number: 503-296-6484
      • Portland, Oregon, United States, 97221
        • Recruiting
        • Retina Northwest, PC
        • Contact:
          • Study Coordinator
          • Phone Number: 971-865-2781
    • South Carolina
      • Aiken, South Carolina, United States, 29803
        • Recruiting
        • Palmetto Retina Center
        • Contact:
          • Study Coordinator
          • Phone Number: 803-867-7058
      • Bluffton, South Carolina, United States, 29910
        • Recruiting
        • Charleston Neuroscience Institute - Bluffton (Site 124)
        • Contact:
          • Study Coordinator
          • Phone Number: 843-278-9938
      • Charleston, South Carolina, United States, 29414
        • Recruiting
        • Charleston Neuroscience Institute (Site 104)
        • Contact:
          • Study Coordinator
          • Phone Number: 843-972-3857
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Recruiting
        • Charles Retina Institute
        • Contact:
          • Study Coordinator
          • Phone Number: 901-683-0399
    • Texas
      • Abilene, Texas, United States, 79606
        • Recruiting
        • Retina Research Institute of Texas (Site 010)
        • Contact:
          • Study Coordinator
          • Phone Number: 325-690-4414
      • Amarillo, Texas, United States, 79106
        • Recruiting
        • Southwest Retina Specialists
        • Contact:
          • Study Coordinator
          • Phone Number: 806-350-1113
      • Arlington, Texas, United States, 76012
        • Recruiting
        • Texas Retina Associates
        • Contact:
          • Study Coordinator
          • Phone Number: 682-433-5453
      • Austin, Texas, United States, 78705
        • Recruiting
        • Austin Research Center for Retina
        • Contact:
          • Study Coordinator
          • Phone Number: 512-454-5851
      • Austin, Texas, United States, 78705
        • Recruiting
        • Austin Retina Associates (Site 012)
        • Contact:
          • Study Coordinator
          • Phone Number: 512-451-0103
      • Bellaire, Texas, United States, 77401
        • Recruiting
        • Retina & Vitreous of Texas
        • Contact:
          • Study Coordinator
          • Phone Number: 281-249-9076
      • Dallas, Texas, United States, 75231
        • Recruiting
        • Texas Retina Associates
        • Contact:
          • Study Coordinator
          • Phone Number: 800-695-6941
      • Plano, Texas, United States, 75075
        • Recruiting
        • Texas Retina (Site 037)
        • Contact:
          • Study Coordinator
          • Phone Number: 469-560-0177
      • Southlake, Texas, United States, 76092
        • Recruiting
        • Retina Center of Texas
        • Contact:
          • Study Coordinator
          • Phone Number: 817-865-6800
      • The Woodlands, Texas, United States, 77384
        • Recruiting
        • Retina Consultants of Texas (Site 014)
        • Contact:
          • Study Coordinator
          • Phone Number: 713-524-3434
      • Weatherford, Texas, United States, 76087
        • Recruiting
        • Strategic Clinical Research Group
        • Contact:
          • Study Coordinator
          • Phone Number: 682-703-4318
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Recruiting
        • Retina Associates of Utah
        • Contact:
          • Study Coordinator
          • Phone Number: 801-312-2020
    • Virginia
      • Lynchburg, Virginia, United States, 24502
        • Recruiting
        • Piedmont Eye Center (Site 054)
        • Contact:
          • Study Coordinator
          • Phone Number: 434-947-3984
    • Washington
      • Burlington, Washington, United States, 98233
        • Recruiting
        • Pacific Northwest Retina (Site 112)
        • Contact:
          • Study Coordinator
          • Phone Number: 360-205-5417

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: Tiespectus
Administered by intravitreal (IVT) injection
Other Names:
  • MK-8748
  • EYE201
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
Drug: Tiespectus
Administered by intravitreal (IVT) injection
Other Names:
  • MK-8748
  • EYE201
Active Comparator: Aflibercept 2 mg
Participants receive 3 initial administrations of aflibercept, then continue to receive aflibercept Q8W until week 92
Drug: Aflibercept
Administered by intravitreal injection (IVT)
Other Names:
  • Eylea®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Change in BCVA (ETDRS Letters) From Baseline (Day 1) Over Time to Year 1
Time Frame: Up 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. The mean change in BCVA from baseline over time to year 1 will be assessed.
Up to Year 1
Proportion of Participants Who Gain ≥5 ETDRS Letters at Year 1
Time Frame: 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.
Year 1
Proportion of Participants Who Gain ≥10 ETDRS Letters at Year 1
Time Frame: 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.
Year 1
Proportion of Participants Who Gain ≥15 ETDRS Letters at Year 1
Time Frame: 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.
Year 1
Proportion of Participants Who Lose ≥5 ETDRS Letters at Year 1
Time Frame: 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.
Year 1
Proportion of Participants Who Lose ≥10 ETDRS Letters at Year 1
Time Frame: 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.
Year 1
Proportion of Participants Who Lose ≥15 ETDRS Letters at Year 1
Time Frame: 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.
Year 1
Mean Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Central Subfield Thickness (CST) From Baseline (Day 1) To Year 1
Time Frame: Baseline and Year 1
CST will be measured in microns using SD-OCT. Mean change in CST from baseline to Year 1 will be assessed.
Baseline and Year 1
Number of Participants who Experience One or More Systemic Adverse Events (AEs)
Time Frame: Up to approximately 96 weeks
An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal clinical laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Up to approximately 96 weeks
Number of Participants who Experience One or More Ocular AEs
Time Frame: Up to approximately 96 weeks

An ocular adverse event (OAE) is defined as any untoward medical occurrence involving the eye or ocular adnexa (including eyelids, conjunctiva, lacrimal apparatus, extraocular muscles, and orbit) that:

Occurs or worsens after the first administration of the investigational product (IP) or a study-related ocular procedure, and does not necessarily have a causal relationship with the IP or procedure.

OAEs include, but are not limited to, changes in: Symptoms (e.g., ocular pain, photophobia, floaters, blurred vision), Visual function (e.g., best-corrected visual acuity [BCVA], visual field). Intraocular pressure (IOP), Anterior segment findings (e.g., conjunctival hyperemia, keratitis, anterior chamber inflammation), Posterior segment findings (e.g., vitreous inflammation, retinal hemorrhages, retinal tears or detachment, macular edema), or ocular adnexa (e.g., eyelid edema, ptosis)
Up to approximately 96 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EyeBiotech Ltd.

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 27, 2026

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

June 30, 2028

Study Registration Dates

First Submitted

February 23, 2026

First Submitted That Met QC Criteria

February 23, 2026

First Posted (Actual)

February 27, 2026

Study Record Updates

Last Update Posted (Actual)

June 15, 2026

Last Update Submitted That Met QC Criteria

June 12, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8748-002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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