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
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 90
- 主要终点
- NEI-VFQ score
研究概览
简要总结
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:
- AREDS2 supplements (Control Group, N=30)
- AREDS2 supplements plus EG-DPMP-01 150 mg daily (Experimental Group, N=60)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Control Arm: AREDS2 supplements (SOC)
All patients assigned to this Control Group will receive standard of care to include AREDS2 supplements daily throughout the study.
干预措施: AREDS2 supplements (Dietary Supplement)
Experomental Arm: AREDS2 supplements (SOC) plus EG-301
Patients assigned to the Experimental Group will receive a standard of care equivalent to that of the Control Group plus EG-DPMP-01 (150 mg daily, given at bedtime with a light snack).
干预措施: EG-301 (Drug)
Experomental Arm: AREDS2 supplements (SOC) plus EG-301
Patients assigned to the Experimental Group will receive a standard of care equivalent to that of the Control Group plus EG-DPMP-01 (150 mg daily, given at bedtime with a light snack).
干预措施: AREDS2 supplements (Dietary Supplement)
结局指标
主要结局
NEI-VFQ score
时间窗: From baseline to Week 26 treatment period
Change in NEI-VFQ score
GA lesion size change
时间窗: From baseline to Week 26 treatment period
The mean change in GA lesion size as measured by a) fundus autofluorescence (FAF) by an independent central reading center (CRC), and b) SD-OCT
Adverse Events Assessment using CTCAE v5.0
时间窗: Evaluation in 26 weeks treatment period, and 4 weeks safety follow up period.
Number of Participants With Treatment-Related Adverse Events as Assessed by NCI CTCAE v5.0, toxicities will be characterized in terms including seriousness, causality, toxicity grading, and action taken with regard to trial treatment.
Low luminance visual acuity (LLVA)
时间窗: From baseline to Week 26 treatment period
The mean change in low luminance visual acuity (LLVA) in number of letters as assessed by the ETDRS protocol
Binocular reading speed
时间窗: From baseline to Week 26 treatment period
Binocular reading speed as assessed by the Minnesota Low-Vision Reading Test (MNRead) Charts
Overall retinal sensitivity
时间窗: From baseline to Week 26 treatment period
Change in overall retinal sensitivity as measured by microperimetry using macular integrity assessment (MAIA)
BCVA in number of letters
时间窗: From baseline to Week 26 treatment period, and 4 weeks safety follow up period.
The mean change in BCVA in the number of letters as assessed by the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol
Binocular critical print size
时间窗: From baseline to Week 26 treatment period
Binocular critical print size as assessed by the Minnesota Low-Vision Reading Test (MNRead) Charts
次要结局
- Plasma levels of bioactive lipids(From baseline to Week 26 treatment period)
- Plasma levels of beclin-1 levels(From baseline to Week 26 treatment period)
- Complement factor levels(From baseline to Week 26 treatment period)