Recruiting NCT07496567
A Clinical Trial of EYE201/MK-8748 in People With Macular Degeneration (MK-8748-003)
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, Brazil, Colombia, Czechia, France +4
- 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 (IVT) injection
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 · 52 centers
- Associated Retina Consultants - Gilbert — Gilbert
- The Retina Partners — Encino
- Northern California Retina Vitreous Associates Medical Group, Inc. — Mountain View
- Orange County Retina Medical Group — Santa Ana
- Retina Consultants of Southern Colorado — Colorado Springs
- RSC Research LLC — Denver
- Retina Consultants of Southern Colorado — Pueblo
- Connecticut Eye Consultants, P.C. — Danbury
- … and 44 more centers
Czechia · 5 centers
- Klaudians Hospital - Ophthalmology department — Mladá Boleslav
- VISUS spol. s r.o. — Náchod
- Axon Clinical, s.r.o. (Site 400) — Prague
- Astra Clinic.s.r.o. — Prague
- Fakultni nemocnice Kralovske — Prague
Colombia · 4 centers
- Clinica Oftalmologica del Caribe (COFCA) — Barranquilla
- Fundacion Oftalmologica Nacional — Bogotá
- Clínica Imbanaco S.A.S — Cali
- Clinica de Oftalmologia Sandiego — Medellín
France · 3 centers
- Hopital Intercommunal De Creteil — Créteil
- Centre d'Ophtalmologie Paradis-Monticelli — Marseille
- Centre Ophtalmologique Saint Exupéry — Saint-Cyr-sur-Loire
Portugal · 2 centers
- AIBILI Azinhaga de Santa Comba — Coimbra
- Espaço Médico de Coimbra — Coimbra
Spain · 2 centers
- Hospital General de Catalunya — Barcelona
- Oftalvist — Burjassot -(Valencia)
Brazil · 1 center
- IPEPO - Instituto Paulista de Estudos e Pesquisas em Oftalmologia (Site 332) — São Paulo
Hungary · 1 center
- Budapest Retina Associates — Budapest
Italy · 1 center
- Presidio Ospedaliero Universitario "Santa Maria della Misericordia" Clinica Oculistica - P — Udine
Identifiers
NCT: NCT07496567 · 8748-003 · MK-8748-003