A Study to Assess the Efficacy and Safety of RO7965032 in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration
A Phase II, Randomized, Double-Masked, Placebo-Controlled Multicenter Study to Assess the Efficacy and Safety of RO7965032 in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration
This study will assess the safety and efficacy of RO7965032 to address a significant unmet medical need in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD)
研究概览
地位
干预/治疗
研究类型
注册 (估计的)
阶段
- 阶段2
联系人和位置
学习联系方式
- 姓名：Fastest Response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
研究联系人备份
- 姓名：Reference Study ID Number: XR46785 https://forpatients.roche.com/No attachments to email below.
- 电话号码：888-662-6728 (U.S. and Canada)
- 邮箱：global-roche-genentech-trials@gene.com
学习地点
-
-
California
-
Walnut Creek、California、美国、94598-5915
- 招聘中
- Bay Area Retina Specialists Medical Group - Vestrum - PPDS
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North Carolina
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Winston-Salem、North Carolina、美国、27103-6945
- 招聘中
- Piedmont Retina Specialists
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-
Pennsylvania
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Erie、Pennsylvania、美国、16505
- 招聘中
- Erie Retina Research
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Texas
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Arlington、Texas、美国、76012-2505
- 招聘中
- Texas Retina Associates - Arlington
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Virginia
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Lynchburg、Virginia、美国、24502-4271
- 招聘中
- Piedmont Eye Center
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
Ocular Inclusion Criteria for the Study Eye
- BCVA score of >= 35 letters using the ETDRS VA chart at a starting distance of 4 meters
- Lesions may be either extrafoveal or subfoveal
Ocular Inclusion Criteria for Both Eyes
- Sufficiently clear ocular media, adequate pupillary dilation, and fixation to permit quality fundus imaging
- Well-demarcated GA secondary to AMD
Exclusion Criteria:
General Exclusion Criteria - History of hypersensitivity, a severe allergic reaction or anaphylactic reaction to any component of the investigational drug injection
Ocular Exclusion Criteria for the Study Eye
- History of diabetic macular edema (DME), retinal vein occlusion, corneal transplant, retinal detachment, Stage 3 or 4 macular hole, optic neuropathy, or retinal dystrophy
- Current or prior history of central serous retinopathy
- Aphakia or absence of the posterior capsule in the study eye
Ocular Exclusion Criteria for the Non-Study Eye
- Non-functioning non-study eye defined as either BCVA of hand motion or worse or no physical presence of non-study eye (i.e., monocular)
Ocular Exclusion Criteria for Either Eye
- Proliferative diabetic retinopathy
- History of recurrent infectious or inflammatory ocular disease
- Current or prior history of choroidal neovascularization (CNV) in either eye
- Active, infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
Other protocol-defined inclusion/exclusion criteria may apply
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
安慰剂比较：Placebo
Participants will receive placebo. |
Placebo will be administered as per the schedule defined in the protocol. |
|
实验性的：RO7965032 Dose Level 1
Participants will receive RO7965032. |
RO7965032 will be administered as per the schedule defined in the protocol. |
|
实验性的：RO7965032 Dose Level 2
Participants will receive RO7965032. |
RO7965032 will be administered as per the schedule defined in the protocol. |
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Change of GA Lesion Area in the Study Eye
大体时间：Baseline up to approximately 48 weeks
|
Baseline up to approximately 48 weeks
|
|
Incidence and Severity of Ocular Adverse Events (AEs)
大体时间：Up to approximately 72 Weeks
|
Up to approximately 72 Weeks
|
|
Incidence and Severity of Non-Ocular AEs
大体时间：Up to approximately 72 Weeks
|
Up to approximately 72 Weeks
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Change of GA Lesion Area in the Study Eye
大体时间：Baseline up to approximately 72 weeks
|
Baseline up to approximately 72 weeks
|
|
Change from Baseline in Best Correct Visual Acuity (BCVA) Score on the Early Treatment Diabetic Retinopathy Study (ETDRS) Chart
大体时间：Baseline up to approximately 48 weeks
|
Baseline up to approximately 48 weeks
|
|
Change from Baseline in BCVA Score on the ETDRS Chart Under Low-luminance Conditions
大体时间：Baseline up to approximately 48 weeks
|
Baseline up to approximately 48 weeks
|
|
Incidence and Severity of Selected Findings in Ocular Examinations and Ocular Imaging
大体时间：Up to approximately 72 Weeks
|
Up to approximately 72 Weeks
|
|
Plasma Concentration of RO7965032
大体时间：Baseline up to approximately 72 weeks
|
Baseline up to approximately 72 weeks
|
|
Percent Change from Baseline in Levels of Target Protein in Plasma
大体时间：Baseline up to approximately 72 weeks
|
Baseline up to approximately 72 weeks
|
|
Percent Change from Baseline in Levels of Plasma Biomarker Activity
大体时间：Baseline up to approximately 72 weeks
|
Baseline up to approximately 72 weeks
|
|
Prevalence and Incidence of Anti-Drug Antibodies (ADAs)
大体时间：Baseline up to approximately 72 weeks
|
Baseline up to approximately 72 weeks
|
|
Recommended Dose of RO7965032
大体时间：Up to approximately 72 Weeks
|
Up to approximately 72 Weeks
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- XR46785
- 2026-527027-10-00 (克蒂斯)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.