2024-513174-22-00招募中2 期
A Phase 2 Multicenter, Randomized, Double-masked, Sham-controlled, Reference-arm Study to Evaluate Efficacy and Safety of ONL1204 in Patients With Geographic Atrophy (GA) Associated With Age-related Macular Degeneration (AMD)
ONL Therapeutics Inc.56 个研究点 分布在 9 个国家目标入组 182 人开始时间: 2025年8月5日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 182
- 试验地点
- 56
- 主要终点
- GA lesion area assessment
研究概览
简要总结
To evaluate the efficacy of ONL1204 compared to sham injection in patients with geographic atrophy (GA) associated with AMD.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •55 years of age or older at Screening.
- •If currently using Age-related Eye Disease Study 2 (AREDS, AREDS2, or similar [see Protocol for formulation]) nutraceutical therapy at Screening, patient must be willing to continue use for the duration of the study. If not currently using AREDS2 or similar, patient must be willing to continue not to use therapy for the duration of the study. Patient must agree to choose either approach.
- •Non-foveal GA associated with AMD without eMNV in the study eye per Investigator’s evaluation and as confirmed by the central RC.
- •BCVA of 24 letters or more using ETDRS charts in the study eye at Screening.
- •BCVA of 19 letters or more using ETDRS charts in the fellow eye at Screening.
排除标准
- •Any ocular or systemic condition that, in the opinion of the Investigator, makes the patient unsuitable for treatment with an investigational drug or that would compromise the safety or efficacy assessments of the study.
- •Individuals who are currently pregnant, planning to become pregnant, or are nursing at Screening or during the study period.
- •Previous IVT pharmaceutical treatment in the study eye with any agent except regionally approved complement inhibitors and treatment with regionally approved complement inhibitors within 12 weeks prior to Screening.
- •Any current evidence or history in the study eye of exudative (“wet”) AMD, including any RPE rips or evidence of actively leaking neovascularization anywhere in the retina based on the FA or SD-OCT as assessed per the Investigator’s evaluation and confirmed by the central RC.
- •Intraocular surgery in the study eye (including lens replacement surgery) within 3 months prior to Screening. See Exclusion Criteria 13 and 14 pertaining to retinal and glaucoma surgery, respectively.
- •Planned or expected IVT injection in the fellow eye for treatment of GA with agents other than regionally approved complement inhibitors during the study period.
- •Active intraocular inflammation in either eye or a history of uveitis or endophthalmitis in either eye.
- •GA in either eye due to causes other than AMD.
- •Any ophthalmic condition in either eye that is likely to require surgery during the study period.
结局指标
主要结局
GA lesion area assessment
GA lesion area assessment
次要结局
未报告次要终点
研究者
Dr. David Zacks
Scientific
ONL Therapeutics Inc.
研究点 (56)
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