A Safety and Efficacy Study of a One-time Intravitreal Injection of SAR446597 in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: SAR446597, Sham Comparator.
- Кому может быть актуально
- Состояния в реестре: Geographic Atrophy. Базовые параметры: от 60 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США, Австралия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
A Phase 1/2, Study to Evaluate the Safety, Tolerability, and Efficacy of One-time Intravitreal Dose of SAR446597 in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration
Обзор
This is a sequential Phase 1/2, two-part, multicenter study on safety, tolerability, and efficacy of one-time intravitreal SAR446597 for the treatment of participants with Geographic Atrophy (GA) secondary to Age-related Macular Degeneration (AMD). The core phase duration will be approximately 2 years for each participant. An Extended Follow-Up (EFU) phase of 3 years follows the core phase. The treatment is a one-time intravitreal injection of SAR446597 (or sham as applicable in Part II).
Вмешательства
- Препарат SAR446597
Intravitreal injection - Препарат Sham Comparator
Sham injection
Первичные конечные точки
- Incidence and severity of ocular and non-ocular treatment-emergent adverse events (TEAEs) [Срок оценки: Day 1 to Week 104]
- Incidence and severity of ocular and non-ocular treatment-emergent serious adverse events (TESAEs) [Срок оценки: Day 1 to Week 104]
Вторичные конечные точки (4)
- Change in square root-transformed (mm) and untransformed area (mm2) of GA [Срок оценки: Baseline, Week 52, Week 104]
- Change in best-corrected visual acuity (BCVA) from baseline to Week 52 and Week 104 following SAR446597 administration measured with the Early Treatment of Diabetic Retinopathy Study (ETDRS) chart [Срок оценки: Baseline, Week 52, Week 104]
- Percentage of participants without loss of BCVA of ≥15 ETDRS letters from baseline in the study eye [Срок оценки: Baseline, Week 52, Week 104]
- Incidence and severity of ocular and non-ocular TEAEs and TESAEs including clinically significant changes in safety parameters [Срок оценки: Week 260 or End of Study]
Критерии участия
Критерии включения
- 60 years old or above
- Participants with diagnosis of GA secondary to age-related macular degeneration (AMD)
- Study eye with best corrected visual acuity (BCVA) ETDRS Snellen equivalent for dose escalation (Part I) between 20/40 and 20/320 and for expansion (Part II) equal or better than 20/200
- Study eye with GA lesion measuring between 2.5 and 17.5 mm2 for dose escalation (Part I) and between 2.5 and 14.0 mm2 for expansion (Part II). For multifocal disease, study eye with at least one single lesion of more than 1.25mm2 for both Part I and Part II
Критерии исключения
- GA in the study eye caused by a disease different than AMD
- Presence of neovascularization or a history of treatment with an anti vascular endothelial growth factor agent in the study eye
- Any condition or treatment (ocular or systemic) or medical or surgical history in the study eye that may prevent visual acuity improvement or interfere with ocular safety or efficacy assessments
- Current or history of systemic complement targeting treatment in the past 12 months
- Use of ocular corticosteroids for 4 months (for ocular or periocular injections), 6 months (for intraocular implants) or 3 years (for long lasting intraocular implants) prior to screening in the study eye
- History of macular laser photocoagulation treatment, photodynamic- or thermotherapy or photo biomodulation in the study eye
- History of active ocular infection in the study eye in 6 months prior to screening
- Presence of active ocular or periocular infections
- Active uncontrolled glaucoma in the study eye
- History of uveitis or scleritis in either eye
- Previous gene therapy in either eye
- Any significant poorly controlled illness that would preclude study compliance and follow up
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Последовательный дизайн
- Маскирование
- Двойное слепое
- Основная цель
- Лечение
Центры проведения
США · 15 центров
- Associated Retina Consultants - Peoria- Site Number : 8400011 — Peoria
- Retina Macula Institute of Arizona- Site Number : 8400028 — Scottsdale
- Vitreo Retinal Associates - Gainesville- Site Number : 8400004 — Gainesville
- Retina Vitreous Associates of Florida - St. Petersburg- Site Number : 8400002 — St. Petersburg
- University Retina - Lemont- Site Number : 8400005 — Lemont
- The Retina Group of Washington - Chevy Chase- Site Number : 8400009 — Chevy Chase
- Cumberland Valley Retina Consultants - Hagerstown- Site Number : 8400003 — Hagerstown
- Oregon Retina- Site Number : 8400017 — Eugene
- … и ещё 7 центров
Австралия · 3 центра
- Investigational Site Number : 0360003 — Sydney
- Investigational Site Number : 0360002 — Adelaide
- Investigational Site Number : 0360001 — East Melbourne
Идентификаторы
NCT: NCT07215234 · DFI18231 · 2025-524508-31