A Clinical Trial of EYE201/MK-8748 in People With Macular Degeneration (MK-8748-002)

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 injection (IVT)

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 · 54 центра

• 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
• … и ещё 46 центров

Аргентина · 18 центров

• 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
• … и ещё 10 центров

Израиль · 8 центров

• Barzilai Medical Center — Ashkelon
• Rambam Health Corporation (Site 706) — Haifa
• Carmel Medical Center (Site 704) — Haifa
• … и ещё 5 центров

Австралия · 5 центров

• 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

Швейцария · 5 центров

Список центров уточняется — проверьте первичный протокол.

Испания · 3 центра

Список центров уточняется — проверьте первичный протокол.

Латвия · 2 центра

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Великобритания · 2 центра

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Идентификаторы

NCT: NCT07440225 · 8748-002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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