Trial to Evaluate the Safety and Efficacy of EB-203 in Patients With Neovascular Age-related Macular Degeneration

Официальное название

A Randomization, Double-blind, Parallel, Multicenter-Phase 2a Trial to Evaluate the Safety and Efficacy of EB-203 in Patients With Neovascular Age-related Macular Degeneration

Обзор

Trial to Evaluate the Safety and Efficacy of EB-203 in Patients with Neovascular Age-related Macular Degeneration. The purpose of this study is to primarily investigate the safety and tolerability of EB-203 by dose in patients with neovascular Age-related Macular Degeneration (nAMD), and to secondarily evaluate the clinical efficacy. Subject to Adults aged 50 years or older and Neovascular age-related macular degeneration (nAMD)

Подробное описание

This study is a double-blind, parallel, multicenter-phase 2a study to evaluate the safety and efficacy of EB-203 in patients with nAMD.

Subjects who have been informed about the study and have voluntarily agreed to sign to participate in the study will be screened.

Final subjects who meet the inclusion/exclusion criteria will be randomized in a 1:1 ratio into Group A(EB-203 2%, 4 times a day) and Group B (EB-203 4%, 4 times a day).

Randomization will be performed using the study institution (hereinafter "institution") as a stratification factor.

Subjects will receive the investigational products according to the group to which they are randomized.

Safety and tolerability will be assessed for 12 weeks after randomization. Efficacy will be assessed at Weeks 4, 8, and 12. In addition, subjects will be monitored by visiting the institution 4 weeks after the last dose of the investigational product (Visit 8).

If a subject meets the criteria for the administration of rescue medication at Visit 3 (Week 2), he/she will be withdrawn from the study.

From Visit 4 (Week4), subjects may be withdrawn from the study based on the withdrawal criteria for each visit or the criteria for the administration of rescue medication.

If a subject who meets the criteria for the administration of rescue medication for each visit is withdrawn from the study, he/she will be administered the anti-VEGF drug aflibercept (product name: Eylea Injection®) once (intraocular injection).

Вмешательства

• Препарат EB-203
  Subjects will receive EB-203 according to the following dosage and administration method for each treatment group.

Первичные конечные точки

• Change in central retinal thickness (CRT) [Срок оценки: Week 12]

Вторичные конечные точки (4)

• Change in BCVA [Срок оценки: Weeks 4, 8, 12]
• Change Proportion (%) in BCVA [Срок оценки: Weeks 4, 8, 12]
• Proportion (%) of subjects with complete disappearance of intraretinal and subretinal fluid [Срок оценки: Weeks 4, 8, 12]
• Proportion (%) of subjects who received rescue medication [Срок оценки: Weeks 4, 8, 12]

Критерии участия

Критерии включения

• Adults aged 50 years or older
• Subjects with a best corrected visual acuity (BCVA) score between 25 and 73, measured by the Early Treatment of Diabetic Retinopathy Study(ETDRS) chart, at a distance of 4 m during the screening (equivalent to 20/40 to 20/320 in the Snellen chart)
• Subjects who voluntarily signed the informed consent form (ICF) after receiving the information on this study

Критерии исключения

• Subjects with confirmed nAMD requiring standard treatment in both eyes (however, dry AMD in the non-study eye may be enrolled)
• Subjects who have received ocular or systemic treatment, such as photodynamic therapy (PDT) or laser photocoagulation, or have undergone a surgical operation for nAMD (however, health functional foods, vitamin supplements, etc., are excluded)
• Subjects whose study eye has been treated with anti-vascular endothelial growth factor (anti-VEGF) drugs (e.g. ranibizumab, bevacizumab, aflibercept, etc.) or a combination therapy for the treatment of nAMD prior to screening
• Subjects who have received intravitreal treatment using steroids
• Subjects who have a subretinal hemorrhage in ≥ 50% of the total lesion area or who have a hemorrhage in the subfoveal region of the study eye and in whom the hemorrhage area is ≥ 1 optic disk area
• Subjects with vitreous hemorrhage in the study eye
• Subjects who have undergone vitrectomy
• Subjects with a history of retinal detachment, congenital disease, or treatment and/or surgical history for retinal detachment
• Subjects with scarring, fibrosis, or atrophy involving the center of the fovea of the study eye
• Subjects with choroidal neovascularization in the study eye due to causes other than nAMD (however, polypoidal choroidal vasculopathy (PCV) can be enrolled)

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

Двойное слепое

Основная цель

Лечение

Центры проведения

South Korea · 5 центров

• Busan Paik Hospital, Inje University — Busan
• Pusan National University Hospital — Busan
• Yeungnam University Medical Center — Daegu
• Kim's Eye Hospital — Seoul
• Seoul National University Hospital — Seoul

Идентификаторы

NCT: NCT06487039 · EB-203-201

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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