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: 1 country
• Sites: 9

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

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 (9)

Northern California Retina Vitreous Associates Medical Group, Inc.

Mountain View, California, 94040, United States

RECRUITING

University Retina & Macula Associates, P.C.

Lemont, Illinois, 60439, United States

RECRUITING

Mid Atlantic Retina Specialists

Hagerstown, Maryland, 21740, United States

RECRUITING

Retina Consultants of Minnesota

Edina, Minnesota, 55435, United States

RECRUITING

Envision Ocular, LLC

Bloomfield, New Jersey, 07003, United States

RECRUITING

Erie Retina Research

Erie, Pennsylvania, 16505, United States

RECRUITING

Charleston Neuroscience Institute

Ladson, South Carolina, 29456, United States

RECRUITING

Retina Consultants of Texas

Bellaire, Texas, 77401, United States

RECRUITING

Pacific Northwest Retina

Bellevue, Washington, 98004, United States

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

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: May 4, 2026

Record last verified: 2026-04

Locations

US (9)