To Evaluate the Safety and Preliminary Efficacy of Intravitreal EXG202 Injection in Patients with Wet (neovascular) Age-related Macular Degeneration (wAMD)

Официальное название

An Open-label, Dose-escalation Study to Evaluate the Safety and Efficacy of Intravitreal EXG202 Injection in Patients with Wet (neovascular) Age-related Macular Degeneration (wAMD)

Обзор

The goal of this clinical trial is to evaluate the safety, tolerability and efficacy of intravitreal injection of EXG202 in subjects with neovascular age-related Macular Degeneration (nAMD).

Подробное описание

EXG 202 is a gene therapy product developed for the treatment of neovascular age-related macular degeneration (nAMD). Neovascular AMD is the main cause of blindness among elderly individuals. The available therapies for treating nAMD require life-long intravitreal (IVT) injections every 4-12 weeks to maintain efficacy. Administration of EXG202 has the potential to treat nAMD by providing durable expression of therapeutic levels of intraocular protein and maintaining the vision of patients. EXG 202 is designed to reduce the current treatment burden which often results in undertreatment and vision loss in patients with nAMD receiving anti-VEGF therapy in clinical practice.

Вмешательства

• Биопрепарат EXG202
  EXG202 is a gene therapy product for the treatment of wet (neovascular) age-related macular degeneration（wAMD） with a single intravitreal injection and administration.

Первичные конечные точки

• Safety and tolerability after EXG202 injection [Срок оценки: up to 52 weeks after treatment]

Вторичные конечные точки (2)

• To evaluate the efficacy after EXG202 injection [Срок оценки: up to 52 weeks after treatment]
• To evaluate the efficacy after EXG202 injection [Срок оценки: 52 weeks following EXG202 treatment.]

Критерии участия

Критерии включения

• Male or female, aged ≥50 years old;
• The study eye must meet the following criteria:

A. Diagnosed of wAMD and current active lesions; active, defined as the presence of any of the following lesions in the macular area upon OCT examination: a) intraretinal hemorrhage or fluid; b) subretinal fluid; c) subretinal hemorrhage; B. The BCVA score tested during screening using the ETDRS eye chart (see Appendix 3 for details) must be between 73-19 letters (including boundary values), (equivalent to Snellen visual acuity of 20/40 to 20/400);

• Clinically meaningful response to standard anti-VEGF therapy within 6 months before screening or during the lead-in period of screening.
• The subject has clear refractive media and sufficient pupil dilation at the time of screening to obtain high-quality retinal images for confirmation of diagnosis;
• Subjects (including male subjects) have no pregnancy plans during the screening period and the entire trial period and voluntarily take effective contraceptive measures and have no sperm or egg donation plans;
• Voluntarily participate in this clinical trial, understand the research procedures and sign the informed consent form before screening; have good compliance and are willing to abide by the research procedures.

Критерии исключения

• The study eye has any eye disease other than wAMD that may affect central vision and/or macular detection (such as macular hole, macular epiretinal membrane, etc.);
• The study eye has a history of retinal detachment or retinal detachment during the screening period (such as rhegmatogenous retinal detachment, tractional retinal detachment, etc.);
• The study eye has MNV caused by reasons other than wAMD (such as diabetic retinopathy, pathological myopia, retinal vein occlusion, angioid streak disease, ocular histoplasmosis, trauma, etc.), and a history of macular pathology unrelated to wAMD;
• The study eye plans to undergo any intraocular surgery during the study period;

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

Китай · 2 центра

• Hebei Eye Hospital — Xingtai
• The Fourth Affiliated Hospital of Zhejiang University School of Medicine — Yiwu

Идентификаторы

NCT: NCT06888492 · EXG202-011

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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