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

Официальное название

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)

Обзор

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.

Вмешательства

• Препарат Tiespectus
  Administered by intravitreal (IVT) injection
• Препарат Aflibercept
  Administered by intravitreal (IVT) injection

Первичные конечные точки

• Mean Change in Best-Corrected Visual Acuity (BCVA) [Early Treatment of Diabetic Retinopathy Study (ETDRS Letters)] From Baseline to Year 1 [Срок оценки: Baseline and Year 1]

Вторичные конечные точки (10)

• Mean Change in BCVA (ETDRS Letters) From Baseline (Day 1) Over Time to Year 1 [Срок оценки: Up to Year 1]
• Proportion of Participants Who Gain ≥5 ETDRS Letters at Year 1 [Срок оценки: Year 1]
• Proportion of Participants Who Gain ≥10 ETDRS Letters at Year 1 [Срок оценки: Year 1]
• Proportion of Participants Who Gain ≥15 ETDRS Letters at Year 1 [Срок оценки: Year 1]
• Proportion of Participants Who Lose ≥5 ETDRS Letters at Year 1 [Срок оценки: Year 1]
• Proportion of Participants Who Lose ≥10 ETDRS Letters at Year 1 [Срок оценки: Year 1]
• Proportion of Participants Who Lose ≥15 ETDRS Letters at Year 1 [Срок оценки: Year 1]
• Mean Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Central Subfield Thickness (CST) From Baseline (Day 1) To Year 1 [Срок оценки: Baseline and Year 1]
• Number of Participants who Experience One or More Systemic Adverse Events (AEs) [Срок оценки: Up to approximately 96 weeks]
• Number of Participants who Experience One or More Ocular AEs [Срок оценки: Up to approximately 96 weeks]

Критерии участия

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

США · 52 центра

• 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
• … и ещё 44 центра

Чехия · 5 центров

• 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

Колумбия · 4 центра

• Clinica Oftalmologica del Caribe (COFCA) — Barranquilla
• Fundacion Oftalmologica Nacional — Bogotá
• Clínica Imbanaco S.A.S — Cali
• Clinica de Oftalmologia Sandiego — Medellín

Франция · 3 центра

• Hopital Intercommunal De Creteil — Créteil
• Centre d'Ophtalmologie Paradis-Monticelli — Marseille
• Centre Ophtalmologique Saint Exupéry — Saint-Cyr-sur-Loire

Португалия · 2 центра

• AIBILI Azinhaga de Santa Comba — Coimbra
• Espaço Médico de Coimbra — Coimbra

Испания · 2 центра

• Hospital General de Catalunya — Barcelona
• Oftalvist — Burjassot -(Valencia)

Бразилия · 1 центр

• IPEPO - Instituto Paulista de Estudos e Pesquisas em Oftalmologia (Site 332) — São Paulo

Венгрия · 1 центр

• Budapest Retina Associates — Budapest

Италия · 1 центр

• Presidio Ospedaliero Universitario "Santa Maria della Misericordia" Clinica Oculistica - P — Udine

Идентификаторы

NCT: NCT07496567 · 8748-003 · MK-8748-003

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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