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

Conditions

• Age-Related Macular Degeneration
• Choroidal Neovascularization
• Macular Degeneration
• Wet Macular Degeneration

Eligibility Criteria

Sex

ALL

Age

50 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Tiespectus — DRUG
  Administered by intravitreal (IVT) injection
• Aflibercept — DRUG
  Administered by intravitreal (IVT) injection

Study Details

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.

Key Dates

First listed

Mar 27, 2026

Start date

Apr 15, 2026

Status verified

Jun 2026

Primary completion

Jul 31, 2028

Completion

Jul 31, 2028

Study Design

Enrollment

960 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

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

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

• Toll Free Number
  1-888-577-8839
  [email protected]

Locations (46)

Find similar trials in Gilbert, AZ

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