A Study to Evaluate KRIYA-825 (VV-14295) in Adults With Geographic Atrophy Secondary to Age-related Macular Degeneration

Официальное название

A Phase 1/2, First-in-Human, Multi-Arm, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Efficacy of an Adeno-associated Virus Vector VV-14295 Administered Suprachoroidally With the Everads Injector In AdultS With GeographIc Atrophy Secondary to Age-related Macular DegeneratiON (the VISION Study)

Обзор

The goal of this study is to evaluate how safe and tolerable KRIYA-825 (VV-14295) is and to determine how effective it is in reducing the growth of geographic atrophy (GA) lesions in the treated eye in patients with GA secondary to age-related macular degeneration (AMD).

Вмешательства

• Генная терапия VV-14295
  VV-14295 will be administered as a single suprachoroidal injection.

Первичные конечные точки

• Incidence and severity of ocular and non-ocular adverse events, abnormal clinical laboratory values, abnormal physical examinations, abnormal vital signs, abnormal electrocardiograms (ECGs), and abnormal ophthalmic findings [Срок оценки: 12 months]
• Incidence and severity of ocular and non-ocular adverse events, abnormal clinical laboratory values, abnormal physical examinations, abnormal vital signs, abnormal ECGs, and abnormal ophthalmic findings [Срок оценки: 12 months]
• Rate of GA progression as assessed by optical coherence tomography (OCT) [Срок оценки: 12 months]

Вторичные конечные точки (9)

• Rate of GA progression as assessed by fundus autofluorescence (FAF) [Срок оценки: 3, 6, and 12 months]
• Rate of GA progression as assessed by OCT [Срок оценки: 3, 6, and 12 months]
• Visual function preservation as assessed by best-corrected visual acuity (BCVA) [Срок оценки: 3, 6, and 12 months]
• Visual function preservation as assessed by low luminance visual acuity (LLVA) [Срок оценки: 3, 6, and 12 months]
• Visual function preservation as assessed by microperimetry [Срок оценки: 3, 6, and 12 months]
• VV-14295 transgene product expression [Срок оценки: 12 months]
• Immune response to VV-14295 [Срок оценки: 12 months]
• Vector shedding profile of VV-14295 [Срок оценки: 12 months]
• Safety of Everads Injector [Срок оценки: 1 day post-dose]

Критерии участия

Критерии включения

• Participant must be between 55 to 80 years of age (inclusive), at the time of signing the informed consent form.
• Body mass index (BMI) of 19 to 34 kg/m2 (inclusive).
• Must agree to use reliable contraception for at least 12 months after administration of VV-14295. A female participant is eligible to participate if she is not pregnant and not breastfeeding.
• The GA lesion must meet certain criteria as assessed by a central reading center's assessment of imaging at Screening.
• Adequate clarity of ocular media, adequate pupillary dilation, and fixation to permit the collection of good quality images as determined by the Investigator.
• For study eye, Normal Luminance BCVA of 55 letters or worse using the ETDRS charts (20/80 or worse) for Part 1a participants or 24 letters or better (approximately 20/320 Snellen equivalent) for Part 1b and Part 2 participants.
• Fellow eye Normal Luminance BCVA of 5 letters or better using ETDRS charts (20/800 or better) for Part 1a participants or 24 letters or better (approximately 20/320 Snellen equivalent or better) for Part 1b and Part 2 participants. Fellow eye must have equivalent or better visual acuity than the study eye.

Критерии исключения

• Any ocular disease or condition that is not GA secondary to AMD: Macular atrophy secondary to a condition other than AMD; Exudative AMD diagnosis or any history of or active macular neovascularization (in study eye or fellow eye) and/or retinal angiomatous proliferation associated with AMD or any other cause; Presence of an active ocular disease that in the opinion of the Investigator compromises or confounds visual function; Active ocular or periocular infection or active uncontrolled intraocular inflammation within 3 months of Screening; History of vitrectomy, retinal detachment, or corneal transplant in the study eye; Active/history of uveitis.
• Any ocular condition that prevents adequate imaging.
• Medical, cognitive or psychiatric conditions that, in the opinion of the Investigator, make consistent study assessment and follow-up over the 12-month Post-Treatment Follow-up Period unlikely, or could increase the risk to the participant by participating in the study or confound the outcome of the study.
• Hospitalization within 1 year prior to Screening that, in the opinion of the Investigator, make consistent study assessment and follow-up over the 12-month Post-Treatment Follow-up Period unlikely, or could increase the risk to the participant by participating in the study or confound the outcome of the study.
• Any Screening test (e.g., ECG) or laboratory value (e.g., hematology) that in the opinion of the Investigator and/or Medical Monitor is clinically significant and renders the participant not suitable for study participation.
• Participant has a direct contraindication to the steroid regimen (both oral and topical) or has a condition that significantly increases the risk of complication.
• Active/history of malignancy within the past 5 years from Screening or any previous therapeutic radiation in the region of the study eye(s) at Screening. History of non-melanoma skin cancers (e.g., basal cell, squamous cell carcinomas), cervical intraepithelial neoplasia (CIN), and localized prostate cancer after treatment are not exclusionary.
• Intraocular surgery (including lens replacement surgery) within 3 months prior to Screening.
• History of laser therapy in the macular region.
• History of intravitreal (IVT) therapy, such as IVT steroid injections, within 6 months prior to Screening.
• COVID-19 vaccine within 90 days of Screening or plan to receive COVID-19 vaccine within 6 months of treatment.
• Active use of systemic immunomodulatory drugs or systemic corticosteroids in the last 60 days. Topical steroids are not exclusionary.
• Prior participation in another interventional clinical study for GA within the past 12 months from the last dosing at Screening.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• Kriya Clinical Study Site — Ottawa

Израиль · 1 центр

• Kriya Clinical Study Site — Tel Aviv

Новая Зеландия · 1 центр

• Kriya Clinical Study Site — Christchurch

Идентификаторы

NCT: NCT06765980 · KRIYA-825-101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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