A Phase 1b, Randomized, Double-masked, Sham-controlled Study of ANX007 Administered as Intravitreal Injections to Assess Safety and Tolerability in Participants With Primary Open-angle Glaucoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- To evaluate the safety and tolerability of ANX007 in participants with primary open-angle glaucoma as measured by occurrence of treatment-emergent adverse events.
研究概览
简要总结
This is a double-masked, randomized, sham-controlled study evaluating two dose levels of ANX007 vs sham, administered as repeat Intravitreal (IVT) injections in patients with Primary Open-angle Glaucoma.
详细描述
This is a phase 1b, double-masked, sham-controlled study evaluating 2 dose levels of ANX007 administered as 2 IVT injections separated by 4 weeks. Approximately 15-29 subjects will be enrolled. An interim analysis of the initial set of 15 participants may be conducted. Based on this analysis, an additional 10-14 participants may be enrolled at a 1:1 ratio to receive one of the two dose levels.
The primary objective is to evaluate the safety and tolerability of repeat IVT injections of ANX007 in participants with primary open-angle glaucoma. Secondary objectives are to evaluate the anterior chamber fluid pharmacokinetics (PK) of ANX007, PD effect of ANX007 on anterior chamber fluid C1q activity, and immunogenicity. An exploratory objective will evaluate ocular PD effect of ANX007.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Male or female age 18 years, and above.
- •Diagnosis of primary open-angle glaucoma.
- •Ability to perform a reliable visual field test in the study eye with a cutoff of 33% for fixation losses and 33% for false-positive response rates.
- •Intraocular pressure (IOP) <21 mm Hg at screening and Day
- •The IOP treatment regimen in the study eye should be stable for at least 4 weeks prior to injection, with no change in the IOP treatment regimen anticipated throughout study participation.
- •Ability to comply with the requirements of the study and complete the full sequence of protocol specified injections, procedures, and evaluations.
排除标准
- •Extensive glaucomatous visual-field damage with a mean deviation worse than -18 dB on Humphrey visual field testing.
- •Any current or prior ocular pathology, other than glaucoma, which could interfere with the conduct of the study including, but not limited to, retinal or optic nerve disease and media opacity in the study eye.
- •History of intraocular inflammatory or infectious eye disease in the study eye.
- •Ocular trauma in the study eye within the preceding 6 months.
- •A history of uncomplicated cataract surgery less than 3 months prior to injection, or trabeculectomy, iridotomy, or other ocular procedures in the study eye that could affect drug distribution and excretion.
- •Any abnormality preventing reliable tonometry in the study eye.
- •Concurrent use of glucocorticoid medications administered by any ocular or systemic route. Nasal, inhaled, and dermatologic (if not administered around the eyes) glucocorticoids are permitted.
- •Receiving monoamine oxidase inhibitor therapy or patient-reported hypersensitivity to any component of apraclonidine, brimonidine, clonidine, phenylephrine, povidone iodine, proparacaine, or ANX
- •Active or history of malignancy within the past 5 years with the exception of curatively treated, basal cell carcinoma.
- •Previous treatment with another humanized monoclonal antibody, Fab or Fab'
- •History of any autoimmune or neurologic disease.
研究组 & 干预措施
2.5mg ANX007
1 in every 3 subjects will be randomized to 2.5mg dose of ANX007.
干预措施: 2.5mg ANX007 (Biological)
5.0mg ANX007
1 in every 3 subjects will be randomized to 5.0mg dose of ANX007.
干预措施: 5.0mg ANX007 (Biological)
Sham Procedure
1 in every 3 subjects will have a sham procedure performed instead of receiving ANX007.
干预措施: Sham Procedure (Other)
结局指标
主要结局
To evaluate the safety and tolerability of ANX007 in participants with primary open-angle glaucoma as measured by occurrence of treatment-emergent adverse events.
时间窗: Day 85
次要结局
- Evaluate PK parameters of ANX007 in serum after repeat injections(Day 29)
- Evaluate PK parameters of ANX007 in aqueous humor after repeat intravitreal injections(Day 29)
- Evaluate PD parameters of ANX007 in aqueous humor after repeat intravitreal injections(Day 29)
- Evaluate PD parameters of ANX007 in serum after repeat intravitreal injections(Day 29)
- Immunogenicity of ANX007 as measured by serum anti-drug antibodies (ADA) after repeat intravitreal injections of ANX007(Day 84)