Safety and Efficacy of AIV007 Periocular Injection in Patients With Neovascular Age-Related Macular Degeneration

Официальное название

A Phase 2, Multicenter, Randomized, Active-controlled Trial of the Safety and Efficacy of AIV007 by Periocular Injection in Patients With Neovascular Age-Related Macular Degeneration

Обзор

The goal of this study is to evaluate whether AIV007 provides benefits to patients with neovascular age-related macular degeneration in improving vision and that it has an acceptable safety profile. Participants will receive either a periocular injection of AIV007 or intravitreal injection of Eylea (control arm) to the study eye and return to the clinic monthly for safety and efficacy observations and/or continued treatment. Participants may receive additional treatment(s) if they meet specified criteria.

Подробное описание

This study will have 2 parts. In Part 1, participants will randomized to receive either AIV007 (6 or 8 mg) or standard of care in a masked fashion and followed for 6 months. The main questions to be answered are:

1. Does AIV007 have an acceptable safety profile? 2. Does AIV007 maintain or improve best corrected visual acuity? 3. Does AIV007 sustain or decrease central subfield thickness? 4. Does AIV007 provide a long duration of effect greater than or equal to 5 months? In Part 2, eligible participants will receive a second injection of AIV007 in an open-labeled design to assess safety and efficacy of repeat doses.

Вмешательства

• Препарат AIV007
  6 mg or 8 mg dose
• Биопрепарат EYLEA® (aflibercept) Injection 2 mg (0.05mL)
  Eylea 2 mg, marketed product

Первичные конечные точки

• Best-corrected Visual Acuity [Срок оценки: Month 6]

Вторичные конечные точки (1)

• Durability [Срок оценки: Month 5]

Критерии участия

Критерии включения

• Previously treated neovascular (wet) age-related macular degeneration (nAMD)
• Responsive to prior intravitreal anti-VEGF therapy
• Study eye at screening must have an ETDRS letter score greater than 35 (20/200 Snellen equivalent)
• Active choroidal neovascularization lesion in the study eye secondary to nAMD.
• Central subfield thickness in the study eye of less than or equal to 370 microns.
• Compliance to all study protocol requirements

Критерии исключения

• Study eye has had previous treatment with cell therapy, brachytherapy, and/or gene therapy
• History of uncontrolled intraocular pressure
• Presence of any clinically significant epiretinal membrane, vitreomacular traction, subfoveal atrophy (including RPE degeneration), RPE tear in the study eye
• History of vitreoretinal surgery, corneal transplant, glaucoma surgery in the study eye or cataract surgery within 3 months before screening visit
• History of vitreous hemorrhage within 3 months prior to screening visit in the study eye
• A clinically significant cataract (including PSC) likely to affect trial outcomes (i.e., vision) in the study eye
• Anterior chamber intraocular lens, aphakia, or violation of the posterior capsule in the study eye; prior Nd:YAG laser posterior capsulotomy in association with posterior intraocular lens implantation is allowed provided it occurred at least 30 days before the screening visit
• Any active bacterial, viral, fungal or parasitic ocular or periocular infection or any history of uveitis in either eye
• Intraretinal fluid (IRF) in the proposed study eye of less than 30 µm confirmed by the CRC following the screening visit

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07557121 · AIV007-E03

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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