A Clinical Study Evaluating the Safety and Efficacy of SKG0106 in Patients With Neovascular Age-related Macular Degeneration (nAMD)

Официальное название

An Open-label, Dose-escalation Study to Evaluate the Safety, Preliminary Efficacy, Immunogenicity and Pharmacokinetic Characteristics of SKG0106 Intraocular Solution After Single Intravitreal Injection in Chinese Patients With Neovascular (Wet) Age-related Macular Degeneration

Обзор

This is a clinical study to evaluate the safety, preliminary efficacy, immunogenicity of SKG0106 in subjects with nAMD.

Вмешательства

• Генная терапия SKG0106
  SKG0106 is a recombinant adeno-associated virus (AAV) vector-based in vivo gene therapeutic product

Первичные конечные точки

• Characteristics of dose limiting toxicities (DLTs) [Срок оценки: 4 weeks]
• Type, severity, and incidence of ocular and systemic adverse events (AEs) [Срок оценки: 48 weeks]

Вторичные конечные точки (3)

• Mean change from baseline in best corrected visual acuity (BCVA) at each visit BCVA of the study eye is examined by the Early Treatment of Diabetic Retinopathy Study (ETDRS) testing at screening and baseline. [Срок оценки: 24 weeks]
• Mean change from baseline in central subfield thickness (CST) at each visit Spectral domain optical coherence tomography (SD-OCT) will be performed to measure CST at screening and at each visit (prior to study drug injection, if available). [Срок оценки: 24 weeks]
• Mean change from baseline in patient-reported outcome (VFQ-25) scale score at each visit Both the total scale and subscale scores of the VFQ-25 is ranging from 0 to 100, and higher scores mean a better outcome. [Срок оценки: 48 weeks]

Критерии участия

Критерии включения

• Voluntary and able to sign a dated ICF prior to any study-related procedures and able to complete the study as required by the protocol;
• Aged ≥ 50 years at screening;

Study Eye:

• Diagnosis of nAMD as determined by the PI;
• Active CNV lesions secondary to age-related macular degeneration (AMD);
• Subjects must have been responsive to anti-VEGF therapy as assessed by the PI prior to study treatment

Критерии исключения

• Any active intraocular or periocular infection or active intraocular inflammation (e.g., infectious conjunctivitis, keratitis, scleritis, endophthalmitis, infectious blepharitis, uveitis) in the study eye at baseline;
• Retinal pigment epithelial tear in the study eye at screening;
• Current vitreous hemorrhage in the study eye or history of vitreous hemorrhage within 4 weeks prior to baseline;
• Any condition that, in the opinion of the investigator, may limit visual acuity improvement in the study eye;
• History of retinal detachment or active retinal detachment in the study eye;
• Any prior gene therapy.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 3 центра

• Peking Union Medical College Hospital — Пекин
• Eye & ENT Hospital of Fudan University — Шанхай
• Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of MedicineXin Hua Hos — Шанхай

Идентификаторы

NCT: NCT06213038 · SKG0106-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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