A Phase 2, Double-masked, Randomized, Multicenter, Parallel Group, Placebo-controlled Study to Investigate the Efficacy and Safety of GAL-101, 2%, Ophthalmic Solution in Patients With Non-foveal Geographic Atrophy Secondary to Non-neovascular Age-related Macular Degeneration: eDREAM Study
概览
- 阶段
- 2 期
- 干预措施
- GAL-101
- 疾病 / 适应症
- 未指定
- 发起方
- Galimedix Therapeutics Inc
- 入组人数
- 110
- 试验地点
- 14
- 主要终点
- Efficacy of GAL-101 ophthalmic solution in reducing the rate of change in GA lesion size.
- 状态
- 招募中
- 最后更新
- 2个月前
概览
简要总结
Age-related macular degeneration (AMD) affects millions of elderly patients. When advanced, there is Geographic Atrophy (GA) in the retina. This means that there is an area with a loss of light-sensitive cells, called photoreceptors. That part of the retina can no longer see. Atrophy begins as a small spot in the retina distant from the fovea which is the part of the retina responsible for sharp central vision. The GA grows, and when it reaches the fovea, vision is severely diminished, and details cannot be seen anymore. The purpose of the eDREAM study is to understand if GAL-101 can slow the growth of GA and prevent it from reaching the fovea. GAL-101 is given as eyedrops. eDREAM patients will administer study eyedrops every day. Patients will be assigned by chance (randomly) to receive either eye-drops that contain the new medication, GAL-101, or eyedrops without the active drug (Placebo). Neither patients nor doctors will know which treatment was assigned to each patient until the end of the study.
详细描述
In this study, if both eyes qualify for the study, the eye with the better BCVA will be defined as the study eye. If both eyes qualify for the study and have identical BCVA, then the eye with higher baseline peripheral retinal degenerations (PRD) will be defined as the study eye. If baseline PRD is identical, then the right eye (OD) will be defined as the study eye. Only the study eye will be dosed with the Investigation Medicinal Product (IMP). During visits, patients will administer 3 applications of 1 drop of GAL-101 or a matching Placebo that does not contain the active pharmaceutical ingredient (API) at 5-minute intervals (i.e., 1st application, wait 5 minutes, 2nd application, wait 5 minutes, 3rd application), under the supervision of trained and authorized study personnel. In between visits, patients will be instructed to administer 2 applications of 1 drop at 5-minute intervals once a day. The study will be comprised of a 12- to 24-month treatment period determined individually according to patients' overall placement in global study randomization. All patients will participate at least 12 months of treatment. The visit schedule includes the following: Screening visits (Visit 1a and 1b) for image capture and confirmation of study eligibility by a reading center; Baseline/Randomization/Day 1 (Visit 2); a phone call at 2 weeks; and on-treatment clinic visits for safety and efficacy evaluations at 1 month, 3 months, 6 months, 9 months, and 12 months. Patients will continue to attend on-treatment clinic visits at 3-month intervals after 12 months until the last patient randomized in the study has completed 12 months of study treatment.
研究者
Chief Scientific Officer
Scientific
Galimedix Therapeutics Inc.
入排标准
入选标准
- •≥55 years of age
- •Willing and able to provide written informed consent
- •Willing and able to comply with the study schedule and study assessments
- •Able to successfully administer ophthalmic solution or have an appropriate designee (e.g., family member, health care professional) who can administer ophthalmic solution
- •BCVA of ≥50 letters in the study eye using Early Treatment Diabetic Retinopathy Study (ETDRS) chart (i.e., 20/100 Snellen equivalent). Criterion will be confirmed at Baseline
- •Refractive error between +3 and -6 diopters spherical equivalent in the study eye
- •Sufficiently clear ocular media and adequate pupillary dilation to permit quality fundus imaging of the study eye, in the opinion of the Investigator. Criterion will be confirmed at Baseline
- •Diagnosed with non-foveal GA secondary to non-neovascular AMD in the study eye, as confirmed by the reading center
- •Well-delineated cumulative GA area between 1.25 and 12.0 mm2
- •If GA is multifocal, at least 1 lesion ≥1.25 mm2
排除标准
- •Presence or history of choroidal neovascularization (CNV). Criterion will be confirmed at Baseline
- •History of laser therapy in the macular region, regardless of indication
- •History of herpes zoster
- •Ophthalmic disease or condition that requires or is likely to require surgery during the study period
- •GA with cumulative area \<1.25 mm2
- •Any GA lesion within 100 µm radius from the center point of the fovea
- •Axial length \>26 mm
- •Any ocular disease or condition other than non-neovascular AMD that may, in the opinion of the Investigator, interfere with study assessments, patient adherence to the study schedule, or interpretation of study data (e.g., epiretinal membrane, macular hole, glaucomatous optic neuropathy, etc.)
- •Intraocular surgery (including cataract extraction and crystalline lens replacement) within 3 months before Visit 1a or yttrium aluminum garnet (YAG) surgery within 2 months before Visit 1a, or planned either during the study period
- •Use of pegcetacoplan or avacincaptad pegol within 6 months before Visit 1a, or planned use during the study period
研究组 & 干预措施
GAL-101 ophthalmic solution
Patient will apply daily 2 eye drops of GAL-101 at 5 minutes interval
干预措施: GAL-101
Placebo
Patient will apply daily 2 eye drops ofPlacebo at 5 minutes interval
干预措施: Placebo
结局指标
主要结局
Efficacy of GAL-101 ophthalmic solution in reducing the rate of change in GA lesion size.
时间窗: From baseline to last on-treatment visit (48 up to 96 weeks)
Comparison between groups of annual rate of change in the area of GA as measured by fundus autofluorescence (FAF).
次要结局
- Efficacy of GAL-101 ophthalmic solution in reducing the rate of change in photoreceptor degeneration (PRD) in eyes with GA(From baseline to last on-treatment visit (48 up to 96 weeks))