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

April 30, 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 Locations

  • United States
    • California
      • Mountain View, California, United States, 94040
        • Recruiting
        • Northern California Retina Vitreous Associates Medical Group, Inc.
        • Contact:
        • Principal Investigator:
          • Mark Wieland
    • Illinois
      • Lemont, Illinois, United States, 60439
        • Recruiting
        • University Retina & Macula Associates, P.C.
        • Contact:
        • Principal Investigator:
          • Veeral Sheth
    • Maryland
      • Hagerstown, Maryland, United States, 21740
        • Recruiting
        • Mid Atlantic Retina Specialists
        • Contact:
        • Principal Investigator:
          • Adam Gerstenblith
    • Minnesota
      • Edina, Minnesota, United States, 55435
        • Recruiting
        • Retina Consultants of Minnesota
        • Contact:
        • Principal Investigator:
          • Zeeshan Haq
    • New Jersey
      • Bloomfield, New Jersey, United States, 07003
        • Recruiting
        • Envision Ocular, LLC
        • Principal Investigator:
          • Patrick Higgins
        • Contact:
    • Pennsylvania
      • Erie, Pennsylvania, United States, 16505
        • Recruiting
        • Erie Retina Research
        • Principal Investigator:
          • David Almeida
        • Contact:
    • South Carolina
      • Ladson, South Carolina, United States, 29456
        • Recruiting
        • Charleston Neuroscience Institute
        • Contact:
        • Principal Investigator:
          • Daniel Alfaro, III
    • Texas
    • Washington
      • Bellevue, Washington, United States, 98004
        • Recruiting
        • Pacific Northwest Retina
        • Contact:
        • Principal Investigator:
          • Todd Klesert

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
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 (IVT) injection
Other Names:
  • Eylea®
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.
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 week48. 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

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)

April 15, 2026

Primary Completion (Estimated)

July 31, 2028

Study Completion (Estimated)

July 31, 2028

Study Registration Dates

First Submitted

March 23, 2026

First Submitted That Met QC Criteria

March 23, 2026

First Posted (Actual)

March 27, 2026

Study Record Updates

Last Update Posted (Actual)

May 4, 2026

Last Update Submitted That Met QC Criteria

April 30, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8748-003
  • MK-8748-003 (Other Identifier: MSD)

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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