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

Part of paid clinical trials in Mountain View, California.

Sponsor
EyeBiotech Ltd.
Study ID
NCT07496567
Phase
PHASE2/PHASE3
Status
Recruiting
Apply to this trial

Conditions

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

Start date
Apr 15, 2026
Status verified
Apr 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 ]

Locations (9)

FacilityCityStateZIPSite coordinators
Northern California Retina Vitreous Associates Medical Group, Inc.Mountain ViewCalifornia94040
John Gonzales
[email protected]
650-963-3465
Mark Wieland (PRINCIPAL_INVESTIGATOR)
University Retina & Macula Associates, P.C.LemontIllinois60439
Maggie Barcewicz
[email protected]
708-765-4110
Veeral Sheth (PRINCIPAL_INVESTIGATOR)
Mid Atlantic Retina SpecialistsHagerstownMaryland21740
April Stockman
[email protected]
301-671-2400
Adam Gerstenblith (PRINCIPAL_INVESTIGATOR)
Retina Consultants of MinnesotaEdinaMinnesota55435
Samantha Schilling
[email protected]
952-259-6262
Zeeshan Haq (PRINCIPAL_INVESTIGATOR)
Envision Ocular, LLCBloomfieldNew Jersey07003
Alysha Berlowitz
[email protected]
973-707-5632
Patrick Higgins (PRINCIPAL_INVESTIGATOR)
Erie Retina ResearchEriePennsylvania16505
Zoraida Santiago
[email protected]
814-200-9152
David Almeida (PRINCIPAL_INVESTIGATOR)
Charleston Neuroscience InstituteLadsonSouth Carolina29456
Sydney Barrett
[email protected]
843-763-4466
Daniel Alfaro, III (PRINCIPAL_INVESTIGATOR)
Retina Consultants of TexasBellaireTexas77401
Rebecca Taing
[email protected]
David Brown (PRINCIPAL_INVESTIGATOR)
Pacific Northwest RetinaBellevueWashington98004
Brianna Hubbard
[email protected]
206-215-3850
Todd Klesert (PRINCIPAL_INVESTIGATOR)

Find similar trials in Mountain View, CA

By condition
Age-related macular degeneration
By specialty
OphthalmologyRetina
By research site
Northern California Retina Vitreous Associates Medical Group, Inc.· Mountain View, CAUniversity Retina & Macula Associates, P.C.· Lemont, ILMid Atlantic Retina Specialists· Hagerstown, MDRetina Consultants of Minnesota· Edina, MNEnvision Ocular, LLC· Bloomfield, NJErie Retina Research· Erie, PA

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