NCT05626114招募中2 期
A Phase IIa, Multicenter, Open-label, Single-Arm Study to Optimize Subretinal Surgical Delivery and to Evaluate Safety and Activity of Opregen in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 27
- 主要终点
- Proportion of Participants With Subretinal Surgical Delivery of OpRegen to Target Regions
研究概览
简要总结
This study will evaluate the success and safety of subretinal surgical delivery as well as the preliminary activity of OpRegen in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). All endpoints are assessed for the study eye unless otherwise indicated.
The substudy will evaluate the operational feasibility and scientific interpretability of incorporating AO retinal imaging using the EarlySight Cellularis® Discovery device. Participants who have fulfilled the eligibility requirements for the parent study and meet the substudy's eligibility criteria will have the option to participate in the substudy. The EarlySight Cellularis® Discovery device will be used only as an assessment tool and data obtained from this device will not be used to guide clinical care or influence clinical outcomes for participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to undergo a vitreoretinal surgical procedure under monitored anesthesia care
- •Diagnosis of GA secondary to AMD
- •Best corrected visual acuity (BCVA) score ≥ 29 letters and ≤ 60 letters in the study eye as assessed by Early Treatment Diabetic Retinopathy Study (ETDRS)
- •Pseudophakic (study eye)
排除标准
- •Pregnancy or breastfeeding
- •History of cognitive impairment or dementia
- •Any type of systemic disease or its treatment, in the opinion of the investigator, including any medical conditions that could be expected to progress, recur, or change to such an extent that it may bias the assessment of the clinical status of the participant to a significant degree or put the participant at special risk
- •Ocular Exclusion Criteria for Study Eye:
- •Any current or history of ocular disease other than GA that may confound assessment of the macula
- •History of retinal detachment
- •History of vitrectomy, glaucoma-filtering surgery, or corneal transplant
- •Uncontrolled glaucoma or advanced glaucoma
- •Any cataract surgery or intraocular surgery within 3 months prior to subretinal surgical delivery of OpRegen
- •History of other ocular or intraocular conditions that contraindicate the use of an investigational drug or may affect interpretation of the study results or may render the participant at high risk for treatment complications
- •Any existing posterior segment device or implant
- •Inclusion Criteria:
- •- Participants must meet all of the inclusion criteria described in the parent study GR44251 and have the ability to comply with the substudy protocol
- •Exclusion Criteria:
- •Participants who meet any exclusion criteria listed in the parent study GR44251
- •Past history of seizures, or epileptic seizures due to any cause except for a single febrile seizure in childhood
研究组 & 干预措施
OpRegen
Experimental
OpRegen dose of up to approximately 200,000 cells will be delivered into the subretinal space.
干预措施: OpRegen (Biological)
结局指标
主要结局
Proportion of Participants With Subretinal Surgical Delivery of OpRegen to Target Regions
时间窗: 3 months post-surgery
Incidence and Severity of Procedure-related Adverse Events (AEs) at 3 Months Following Surgery
时间窗: 3 months post-surgery
次要结局
- Proportion of Participants With Qualitative Improvement in Retinal Structure, as Determined by Optical Coherence Tomography (OCT) Imaging Within 3 Months Following Surgery(3 months post-surgery)
研究者
研究点 (27)
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相关资讯
Lineage Cell Therapeutics Launches COR1 Cell Therapy Program to Address Global Corneal Transplant Shortage- Lineage Cell Therapeutics has launched COR1, a preclinical corneal endothelial cell therapy program targeting Fuchs endothelial corneal dystrophy and bullous keratopathy using its proprietary AlloSCOPE platform.
- The program addresses a critical unmet need, as global demand for corneal transplants reaches 12.7 million cases annually while only one donor cornea is available for every 70 diseased eyes.
- COR1 leverages manufacturing expertise from Lineage's OpRegen program and aims to provide a consistent, off-the-shelf allogeneic source of corneal endothelial cells without relying on human organ donors.
- Fuchs endothelial corneal dystrophy affects approximately 7.33% of adults over 30 years globally, with the patient population projected to rise from 300 million in 2020 to 415 million by 2050.5 months ago36-Month Results of OpRegen Cell Therapy for Geographic Atrophy to Be Presented at CTS 2025- Long-term 36-month data from the Phase 1/2a trial of RG6501 (OpRegen) for geographic atrophy secondary to AMD will be presented at Clinical Trials at the Summit in June 2025.
- OpRegen, an allogeneic retinal pigment epithelial cell therapy developed by Lineage Cell Therapeutics in collaboration with Roche and Genentech, aims to counteract RPE cell loss in geographic atrophy.
- The therapy is currently advancing in a separate Phase 2a clinical study, potentially offering a novel treatment approach for geographic atrophy, a leading cause of adult blindness affecting over 5 million people globally.last year