REGN22530 for Adults With Primary Open Angle Glaucoma or Ocular Hypertension (BAHAMA)
A Phase 1/2 Study of REGN22530 in Participants With Primary Open Angle Glaucoma or Ocular Hypertension
This study will test an experimental drug called REGN22530 ("study drug") to see if it can help treat people with primary open angle glaucoma or ocular hypertension. REGN22530 is an experimental drug that is designed to bind with a protein in the eye that has been shown to cause a buildup of fluid inside the eye and cause increased Intraocular Pressure (IOP).
REGN22530 attaches to this protein and stops it from working which may allow more fluid to drain out of the eye and decrease the pressure.
The study is looking at:
- What side effects REGN22530 might cause
- How much REGN22530 is in the blood and eye fluid at different times
- If the body has any reactions to REGN22530 (which may cause REGN22530 to not work as well)
- How the body and eye pressure respond after having REGN22530, which can help researchers understand why REGN22530 works better in some people than others
- How well REGN22530 works
研究概览
研究类型
注册 (估计的)
阶段
- 阶段2
- 阶段1
联系人和位置
学习联系方式
- 姓名:Clinical Trials Administrator
- 电话号码:844-734-6643
- 邮箱:clinicaltrials@regeneron.com
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Key Inclusion Criteria:
- Diagnosis of OHT or POAG of mild to moderate severity as described in the protocol
- Best-Corrected Visual Acuity (BCVA) of ≥35 Early Treatment Diabetic Retinopathy Study (ETDRS) letters (Snellen equivalent of better than or equal to 20/200) in the study eye on day 1
- BCVA of ≥55 EDTRS letters (Snellen equivalent of better than or equal to 20/80) in the non-study eye on day 1
- Phakic or pseudophakic with a posterior chamber intraocular lens that has been implanted ≥3 months prior to Screening Visit 1
- Sufficiently clear ocular media, adequate pupillary dilation and fixation to permit quality posterior segment imaging in the study eye
Key Exclusion Criteria:
Ocular-specific exclusion criteria apply to the Study Eye only, unless otherwise specified.
- OAG or OHT secondary to pigment dispersion, pseudoexfoliation, trauma, uveitis, neovascularization, a vascular disorder, or steroid use
- Congenital or traumatic cataract, or visually significant cataract that is likely to require surgical intervention during the study
- Presence of significant corneal scarring or irregularities that could interfere with reliable IOP measurement
- Prior incisional or bleb-forming glaucoma surgery, suprachoroidal procedures, Trabecular Meshwork (TM)-stripping Microinvasive Glaucoma Surgery (MIGS), angle-based implants other than iStent or iridectomy/iridotomy as described in the protocol
- History of Selective Laser Trabeculoplasty (SLT) within 6 months prior to day 1
- History of transscleral (including micropulse) or endoscopic cyclophotocoagulation within 1 year prior to day 1
Note: Other protocol defined Inclusion/ Exclusion criteria 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:顺序分配
- 屏蔽:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Phase 1 Part A
|
Administered per the protocol
|
|
实验性的:Phase 1 Part B
|
Administered per the protocol
|
|
实验性的:Phase 2 Part C
|
Administered per the protocol
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Occurrence of Treatment Emergent Adverse Events (TEAEs)
大体时间:Up to week 16
|
Part A and B
|
Up to week 16
|
|
Change from baseline in mean diurnal IOP in the study eye
大体时间:At day 85
|
Part C
|
At day 85
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Concentrations of REGN22530 in serum
大体时间:Up to week 24
|
Up to week 24
|
|
|
Occurrence of Anti-Drug Antibodies (ADAs) to REGN22530 in serum
大体时间:Up to week 24
|
Up to week 24
|
|
|
Magnitude of ADAs to REGN22530 in serum
大体时间:Up to week 24
|
Up to week 24
|
|
|
Occurrence of TEAEs
大体时间:Up to week 24
|
Part C
|
Up to week 24
|
合作者和调查者
调查人员
- 研究主任:Clinical Trial Management、Regeneron Pharmaceuticals
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
- R22530-IOP-2558
- 2026-526004-76-00 (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
IPD 共享时间框架
When Regeneron has:
- received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development
- made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry)
- the legal authority to share the data, and
- ensured the ability to protect participant privacy
IPD 共享访问标准
IPD 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
- 分析代码
- 企业社会责任
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.