Study to Evaluate Safety and Efficacy of EG-301 in Patients With Nonfocal Geographic Atrophy Secondary to Dry-AMD

Официальное название

A Phase 2, Parallel, Randomized, Open-label, Controlled Study of EG-301 150 mg Daily in Patients With Nonfocal Geographic Atrophy Secondary to Dry-AMD

Обзор

This is a parallel, randomized, open-label, controlled study to evaluate the efficacy and safety of oral EG-301 in patients with intermediate non-exudative (dry) age-related macular degeneration (dAMD). Ninety patients will be randomly allocated in a 2:1 ratio to one of two treatment arms for at least 6 months duration. The two treatment arms are: 1. AREDS2 supplements (Control Group, N=30) 2. AREDS2 supplements plus EG-DPMP-01 150 mg daily (Experimental Group, N=60)

Вмешательства

• Препарат EG-301
  The investigation drug, EG-301 Tablets 150mg, is for oral use.
• Пищевая добавка AREDS2 supplements
  AREDS2 supplement is the stand of care

Первичные конечные точки

• Adverse Events Assessment using CTCAE v5.0 [Срок оценки: Evaluation in 26 weeks treatment period, and 4 weeks safety follow up period.]
• GA lesion size change [Срок оценки: From baseline to Week 26 treatment period]
• Overall retinal sensitivity [Срок оценки: From baseline to Week 26 treatment period]
• BCVA in number of letters [Срок оценки: From baseline to Week 26 treatment period, and 4 weeks safety follow up period.]
• Low luminance visual acuity (LLVA) [Срок оценки: From baseline to Week 26 treatment period]
• Binocular reading speed [Срок оценки: From baseline to Week 26 treatment period]
• Binocular critical print size [Срок оценки: From baseline to Week 26 treatment period]
• NEI-VFQ score [Срок оценки: From baseline to Week 26 treatment period]

Вторичные конечные точки (3)

• Plasma levels of bioactive lipids [Срок оценки: From baseline to Week 26 treatment period]
• Plasma levels of beclin-1 levels [Срок оценки: From baseline to Week 26 treatment period]
• Complement factor levels [Срок оценки: From baseline to Week 26 treatment period]

Критерии участия

Критерии включения

• Male or female patients, 50 to 75 years of age at screening visit
• Subject has signed the Informed Consent form
• Subjects with intermediate nonfocal geographic atrophy secondary to Non-Exudative (dry) AMD having ETDRS BCVA between 35 and 80 letters read (equivalent to 20/25 - 20/200 on Snellen Chart) with the level of vision caused by the non-exudative AMD and no other factor/s
• Subjects with symptomatic decrease in visual acuity in the last 12 months
• Subjects with confirmed diagnosis of geographic atrophy (GA) secondary to dAMD in the study eye\* as evidenced by the following characteristics:

• Non-center involving GA lesions that reside completely within the FAF imaging field (field 2, 30 degree image centered on the fovea)
• Total GA area is ≥2.5 and ≤ 17.5 mm2 (1 and 7 disk areas \[DA\])
• If GA is multifocal, at least one focal lesion must be >1.25 mm2 (0.5 DA)
• Combination of areas of RPE disturbances described as a pattern of hyper or hypo-pigmentation in the junctional zone of GA. Absence of hyper-autofluorescence is exclusionary
• Subjects with evidence of reasonably well-preserved areas of RPE by clinical examination and well-defined RPE and outer segment ellipsoid line by OCT examination in the central 1 mm of the macula as confirmed by the central reading center. More specifically, reasonably well- preserved central 1 mm of the macula means:

• The RPE and outer retinal layers throughout the central 1 mm are intact
• No signs of NVAMD such as intraretinal or sub retinal fluid, or sub retinal hyper-reflective material
• No serous pigment epithelium detachments >100 microns in height
• Sufficiently clear ocular media, adequate pupillary dilation, fixation to permit quality fundus imaging, and able to cooperate sufficiently for adequate ophthalmic visual function testing and anatomic assessment

Критерии исключения

• Females who are pregnant, nursing, planning a pregnancy during the study or who are of childbearing potential not using a reliable method of contraception and/or not willing to maintain a reliable method of contraception during their participation in the study. Women of childbearing potential with a positive urine pregnancy test administered at baseline are not eligible to receive study drug
• Prior cataract surgery is allowed up to 90 days before the baseline visit, but refractive surgery in either eye may not be conducted during the study.
• Subject with exudative AMD or choroidal neovascularization (CNV), including any evidence of retinal pigment epithelium rips, detachments or evidence of neovascularization anywhere in either eye based on SD-OCT imaging and/or fluorescein angiography as assessed by the Reading Center
• Subjects who had anti-VEGF IVT in either eye in the past 90 days
• Subjects who have received any drug or herbal medicine known to inhibit CYP2D6 enzyme activity prior to the first dose of the investigational drug (the patient can be enrolled if the washout period is ≥5 half-lives of the CYP2D6 inhibitor), or subjects who need to continue receiving these medications during the study period. (Refer to Appendix 1 for a list of CYP2D6 inhibitors)
• Subjects with moderate or severe renal impairment as indicated by an estimated glomerular filtration rate (eGFR) <60 mL/min, calculated by using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)

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

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT05170048 · EG-301-2.1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗