A Randomized, Multi-Center, Single Masked, Sham Controlled, Proof-of-Concept Study of Intravitreal CLG561 as a Monotherapy and in Combination With LFG316 in Subjects With Geographic Atrophy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 114
- 主要终点
- Mean Change From Baseline in Intraocular Pressure (IOP)
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of 12 (every 28 days) intravitreal (IVT) injections of CLG561 as a monotherapy and in combination with LFG316 as compared to sham in subjects with geographic atrophy.
详细描述
This study consists of an up-to 30-day screening period, an approximately 336-day treatment period, and a follow-up period consisting of two visits occurring 4 and 16 weeks after the last administered injection.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sign written informed consent form;
- •Geographic atrophy in both eyes;
- •Other protocol-specified inclusion criteria may apply.
排除标准
- •Pregnant or lactating women and women of child-bearing potential;
- •Any medical condition (systemic or ophthalmic) that may preclude the safe administration of test article or safe participation in this study;
- •Any contraindications or hypersensitivities to any component of the LFG316 or CLG561 solution;
- •Any contraindications to IVT injections;
- •Ocular surgery in either eye within 90 days of screening;
- •Uncontrolled ocular hypertension or glaucoma in the study eye;
- •Other protocol-specified exclusion criteria may apply.
研究组 & 干预措施
CLG561
CLG561 10 mg, one IVT injection every 28 days for a total of 12 injections
干预措施: CLG561 (Drug)
CLG561+LFG316
CLG561 5mg + LFG316 5 mg, one IVT injection every 28 days for a total of 12 injections
干预措施: CLG561 (Drug)
CLG561+LFG316
CLG561 5mg + LFG316 5 mg, one IVT injection every 28 days for a total of 12 injections
干预措施: LFG316 (Drug)
Sham Injection
One sham injection every 28 days for total of 12 sham injections
干预措施: Sham injection (Drug)
结局指标
主要结局
Mean Change From Baseline in Intraocular Pressure (IOP)
时间窗: Baseline (Day 1), Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 197, Day 225, Day 253, Day 281, Day 309
IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry and reported in millimeters of mercury (mmHg). A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). Baseline is defined as the last measurement prior to first dose of treatment. A more negative change indicates a greater amount of improvement. One eye (study eye) contributed to the analysis. No statistical analysis was conducted.
Change in GA Lesion Size From Baseline to Day 337 as Measured by Fundus Autofluorescence (FAF)
时间窗: Baseline (Day 1), Day 337
Geographic atrophy, also known as atrophic age-related macular degeneration (AMD) or advanced dry AMD, is an advanced form of age-related macular degeneration that can result in the progressive and irreversible loss of retina which can lead to a loss of visual function over time. Geographic atrophy (GA) lesion size was assessed by a Central Reading Center (CRC) using FAF. Baseline is defined as the last measurement prior to first dose of treatment. One eye (study eye) contributed to the analysis.
Number of Subjects With a Serious Adverse Event That, in the Opinion of the Investigator, is Related to the Study Drug
时间窗: Up to Day 421
A serious adverse event (SAE) was defined as any adverse experience that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event. All SAEs related to the study drug are reported. No statistical analysis was conducted.
次要结局
- Change in GA Lesion Size From Baseline to Day 85, 169, and 253 as Measured by FAF(Baseline (Day 1), Day 85, Day 169, Day 253)
- Mean Change in GA Lesion Size From Baseline to Day 421 as Measured by FAF(Baseline (Day 1), Day 421)
- Change in Low Luminance Visual Acuity (LLVA) From Baseline up to Day 337 as Measured by ETDRS(Baseline (Day 1), Day 2, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 197, Day 225, Day 253, Day 281, Day 309, Day 337)
- Change in LLVA Deficit From Baseline up to Day 337 as Measured by ETDRS(Baseline (Day 1), Day 2, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 197, Day 225, Day 253, Day 281, Day 309, Day 337)
- Average Change in BCVA From Baseline to the Period Day 281 to Day 337 as Measured by ETDRS(Baseline (Day 1), Day 281, Day 309, Day 337)
- Average Change in LLVA From Baseline to the Period Day 281 to Day 337 as Measured by ETDRS(Baseline (Day 1), Day 281, Day 309, Day 337)
- Change in Best Corrected Visual Acuity (BCVA) From Baseline by Visit up to Day 337 as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS)(Baseline (Day 1), Day 2, Day 8, Day 15, Day 29, Day 30, Day 57, Day 85, Day 113, Day 141, Day 169, Day 197, Day 225, Day 253, Day 281, Day 309, Day 337)
- Average LLVA Deficit (Letters) Change From Baseline at Day 281 to Day 337 as Measured by ETDRS(Baseline (Day 1), Day 281, Day 309, Day 337)
- Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS(Baseline (Day 1), Day 2, Day 8, Day 15, Day 29, Day 30, Day 57, Day 85, Day 113, Day 141, Day 169, Day 197, Day 225, Day 253, Day 281, Day 309, Day 337)
- Total CLG561 Serum Concentrations up to Day 421(Baseline (Day 1), Day 2, Day 8, Day 15, Day 29, Day 85, Day 169, Day 253, Day 309, Day 337, Day 421)
- Total LFG316 Serum Concentration up to Day 421(Baseline (Day 1), Day 337, Day 421)
- Percentage of Subjects With Anti-CLG561 Antibodies up to Day 421(Baseline (Day 1), up to Day 421)
- Percentage of Subjects With Anti-LFG316 Antibodies up to Day 421(Baseline (Day 1), up to Day 421)