A Phase 1b Multicenter, Randomized, Single-Masked, Sham-Controlled Study of the Safety and Tolerability of ONL1204 Ophthalmic Solution in Patients with Progressing Open Angle Glaucoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 11
- 主要终点
- Safety and Tolerability of ONL1204 as assessed by AE reporting and clinical evaluations
研究概览
简要总结
The purpose of this study is to demonstrate the safety and tolerability of ONL1204 Ophthalmic Solution in patients with progressing open angle glaucoma.
ONL1204 Ophthalmic Solution is a first-in-class inhibitor of fragment apoptosis stimulator (Fas) receptor-mediated cell death that has demonstrated protection of multiple retinal cell types in numerous preclinical models of retinal disease. Apoptosis of retinal ganglion cells is associated with progressive glaucoma. Nonclinical data on ONL1204 Ophthalmic Solution suggest that ONL1204 Ophthalmic Solution may inhibit the cell death pathways in these cells.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females aged ≥18 years old
- •Able and willing to give informed consent and attend study visits
- •Controlled intraocular pressure (IOP) (≤21 mmHg) in both eyes for all previous 3 visits before Screening and at Screening in both eyes
- •Prior to screening, 3 or more Humphrey Visual Field (HVF) tests (with acceptable reliability standards) or 3 or more Optical Coherence Tomography (OCT) studies of the study eye on record
- •Open angle glaucoma that is progressing in the study eye
- •HVF 24-2 at Screening with acceptable reliability standards and MD scores
排除标准
- •Considerations for either eye
- •Best Corrected Visual Acuity (BCVA) at Screening of ≤64 letters (Snellen equivalent of worse than 20/50)
- •Severe open angle glaucoma
- •Glaucoma due to non-open angle causes
- •Worse than mild non-proliferative diabetic retinopathy
- •Considerations for study eye:
- •Visual field results suggestive of another disease (eg, altitudinal field defect)
- •Evidence of macular edema based on OCT imaging and Investigator's judgement
- •Previous intravitreal (IVT) injections, history of retinal surgery, history of retinal laser
- •Cataract surgery within 3 months of Screening or yttrium-aluminum-garnet capsulotomy (YAG) within 4 weeks of Screening
- •Anticipated need for surgical or procedural intervention for glaucoma, cataract, posterior capsular opacity, refractive error, or retinal conditions during the study
- •Other general exclusion criteria:
- •The requirement for oral carbonic anhydrase inhibitors to control intraocular pressure
- •Severe, unstable, or uncontrolled cardiovascular, diabetic, renal, or pulmonary disease, based on Investigator's judgement
- •Systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg
- •Women who are pregnant, breastfeeding, or contemplating pregnancy during the study period and men who are contemplating contributing sperm for a biologic child during the study period
- •Participation in other ophthalmic clinical trials or use of any other investigational drugs or devices in either eye or systemically for 3 months before Screening (Visit 1)
研究组 & 干预措施
Treatment Group A
ONL1204 Ophthalmic solution (Dose A) administered by intravitreal injection
干预措施: ONL1204 Ophthalmic solution (Dose A) (Drug)
Treatment Group B
ONL1204 Ophthalmic solution (Dose B) administered by intravitreal injection
干预措施: ONL1204 Ophthalmic solution (Dose B) (Drug)
Treatment Group C
Sham procedure without penetrating the eye
干预措施: Sham procedure (Procedure)
结局指标
主要结局
Safety and Tolerability of ONL1204 as assessed by AE reporting and clinical evaluations
时间窗: up to 39 weeks
Adverse event reporting, ophthalmic examination to evaluate the anterior and posterior segments of the eye, best-corrected visual acuity, intraocular pressure, electroretinogram, vital signs, clinical laboratory evaluations, and ophthalmic imaging results
次要结局
未报告次要终点