A Clinical Trial of EYE201/MK-8748 in People With Macular Degeneration (MK-8748-002)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tiespectus, Aflibercept.
- Who it may be relevant to
- Registry conditions: Macular Degeneration, Age-Related Macular Degeneration, Choroidal Neovascularization, Wet Macular Degeneration. Basic parameters: from 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Argentina, Australia, Israel, Latvia +3
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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)
Overview
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.
Interventions
- Drug Tiespectus
Administered by intravitreal (IVT) injection - Drug Aflibercept
Administered by intravitreal injection (IVT)
Primary outcome measures
- 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]
Secondary outcome measures (10)
- Mean Change in BCVA (ETDRS Letters) From Baseline (Day 1) Over Time to Year 1 [Time frame: Up to Year 1]
- Proportion of Participants Who Gain ≥5 ETDRS Letters at Year 1 [Time frame: Year 1]
- Proportion of Participants Who Gain ≥10 ETDRS Letters at Year 1 [Time frame: Year 1]
- Proportion of Participants Who Gain ≥15 ETDRS Letters at Year 1 [Time frame: Year 1]
- Proportion of Participants Who Lose ≥5 ETDRS Letters at Year 1 [Time frame: Year 1]
- Proportion of Participants Who Lose ≥10 ETDRS Letters at Year 1 [Time frame: Year 1]
- Proportion of Participants Who Lose ≥15 ETDRS Letters at Year 1 [Time frame: 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]
- Number of Participants who Experience One or More Systemic Adverse Events (AEs) [Time frame: Up to approximately 96 weeks]
- Number of Participants who Experience One or More Ocular AEs [Time frame: Up to approximately 96 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 54 centers
- Research Network Arizona / Retina Macula Institute of Arizona — Scottsdale
- Retina Center of Arkansas — Fayetteville
- Retina Partners of Northwest Arkansas, PLLC — Springdale
- Global Research Management, Inc. — Glendale
- Retinal Consultants Medical Group (Site 024) — Modesto
- Retina Consultants of Southern California (Site 043) — Redlands
- Retinal Consultants Medical Group (Site 020) — Sacramento
- Retinal Consultants Medical Group (Site 022) — Sacramento
- … and 46 more centers
Argentina · 18 centers
- Grupo Laser Vision (Rosario Eximer Laser Vision SA) — Rosario
- Oftalmología Global (Centro Médico Oftalmología Global) (Site 304) — Rosario
- Microcirugia Ocular Rosario (Site 310) — Rosario
- Centro de Ojos Quilmes — Buenos Aires
- Fundacion Jorge Zambrano para la investigación, diagnostivo y tratamiento de enfermedades — Buenos Aires
- RSresearch (Site 308) — Buenos Aires
- Instituto Oftalmologico de Buenos Aires SA (Site 306) — Buenos Aires
- Centro Oftalmologico Dr Charles y Asociados (Site 300) — Buenos Aires
- … and 10 more centers
Israel · 8 centers
- Barzilai Medical Center — Ashkelon
- Rambam Health Corporation (Site 706) — Haifa
- Carmel Medical Center (Site 704) — Haifa
- … and 5 more centers
Australia · 5 centers
- Eye Clinic Albury Wodonga (Site 425) — Albury
- Marsden Eye Specialists (Site 420) — Parramatta
- Marsden Eye Specialists (Site 423) — Strathfield
- Sydney Eye Hospital (Site 426) — Sydney
- Sydney Retina Clinic and Day Surgery (Site 424) — Sydney
Switzerland · 5 centers
Center list to be confirmed — check the primary protocol.
Spain · 3 centers
Center list to be confirmed — check the primary protocol.
Latvia · 2 centers
Center list to be confirmed — check the primary protocol.
United Kingdom · 2 centers
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07440225 · 8748-002