A Phase IIb Randomized, Multicenter Trial of Subretinal CPCB-RPE1 in Advanced Dry AMD (Geographic Atrophy)

Официальное название

A Phase IIb, Randomized, Assessor-Masked, Multicenter Clinical Trial to Assess the Safety and Efficacy of Subretinal Implantation of the CPCB-RPE1 Implant in Subjects With Advanced, Dry Age-Related Macular Degeneration (Geographic Atrophy) - PATCH AMD

Обзор

This is a Phase IIb randomized, clinical trial designed to assess the safety and efficacy of unilateral implantation of the CPCB-RPE1 implant in subjects with geographic atrophy involving the fovea. Up to 6 surgical implantation sites will deliver the CPCB-RPE1 in this Phase IIb clinical trial. Additional study sites may serve as referral or follow-up sites. Twenty-four (24) subjects will participate in the trial and will be randomized 3:1 to one of 2 groups: * The treatment group receiving the CPCB-RPE1 implant (up to 18 subjects). * The control group receiving a simulated "sham" implantation procedure (up to 6 subjects)

Вмешательства

• Устройство Surgical implantation of the CPCB-RPE1 implant
  Surgical implantation of the CPCB-RPE1 implant

Первичные конечные точки

• Change in retinal sensitivity [Срок оценки: 1 year post implantation]

Вторичные конечные точки (1)

• Change in best corrected visual acuity [Срок оценки: 1 year post implantation]

Критерии участия

Eligible participants include:

• Age 55 to 90 years of age (inclusive), presenting with geographic atrophy involving the fovea in advanced, age-related, dry AMD.
• Clinical findings consistent with advanced dry AMD with evidence of one or more areas of ≥4.0mm2 but not exceeding 15.0 mm2 of geographic atrophy involving the fovea.
• Geographic atrophy defined as attenuation or loss of RPE as observed by biomicroscopy, OCT, or FAF.
• The best-corrected visual acuity (BCVA) of the eye to receive the implant will be ≥20/200 (35 EDTRS letters) to 20/63 (60 EDTRS letters) inclusive. The BCVA of the eye that is NOT to receive the implant will be better or equal to the eye that will receive the implant.
• Medically suitable to undergo pars plana vitrectomy and the surgical implant procedure, including being able to position post-operatively and use post-operative medications as required.
• Medically suitable for general anesthesia or monitored intravenous sedation, if needed.
• Pseudophakic in the study eye, to remove the risk of cataract formation following vitrectomy.
• Participants also must be willing and able to provide written, signed informed consent for this study.
• Participants able to complete the baseline microperimetry retinal sensitivity testing.
• On baseline microperimetry, participants must have ≥5 spots in the perilesional region with a retinal sensitivity between 3 and 17 Db.

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

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 5 центров

• Retina-Vitreous Associates Medical Group — Beverly Hills
• Retina Associates of Southern California — Huntington Beach
• USC - Keck — Los Angeles
• University Retina — Lemont
• Retina Consultants of Texas — The Woodlands

Идентификаторы

NCT: NCT06557460 · RPT-14-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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