ODYSSEY: A Phase 2b Study of Suprachoroidally Administered CLS-AX in Participants With Neovascular Age-Related Macular Degeneration
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 32
- 主要终点
- Evaluations of Outcomes Related to ETDRS BCVA in the Study Eye Over Time
研究概览
简要总结
Phase 2b, randomized, double-masked, parallel-group, active-controlled, multicenter, 36-week study designed to assess the safety and efficacy of suprachoroidally administered CLS-AX 1.0 mg with a flexible dosing regimen in participants with neovascular age-related macular degeneration previously treated with intravitreal anti-vascular endothelial growth factor (VEGF) standard of care therapy. Only one eye will be chosen as the study eye.
详细描述
Phase 2b, randomized, double-masked, parallel-group, active-controlled, multicenter, 36-week study designed to assess the safety and efficacy of suprachoroidally administered CLS-AX 1.0 mg with a flexible dosing regimen in participants with neovascular age-related macular degeneration previously treated with intravitreal anti-VEGF standard of care therapy. Active-control will be 2 mg intravitreal injections of aflibercept dosed per the EYLEA Prescribing Information. Only one eye will be chosen as the study eye.
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)
盲法说明
The participant, Sponsor, Principal (non-injecting) Investigator, medical monitor, study coordinator, visual acuity technician, photographer, central reading center, and central laboratory will be masked to treatment assignment for the duration of the study.
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
- •Diagnosis of neovascular age-related macular degeneration (nAMD) in the study eye within 36 months of Visit
- •Subfoveal choroidal neovascularization (CNV) secondary to nAMD of any lesion type in the study eye that shows total lesion area ≤30 mm2, CNV component area of ≥50% of the total lesion area, and and CNV must not be associated with subfoveal hemorrhage, subfoveal fibrosis, or subfoveal atrophy.
- •Previous treatment in the study eye with between 2 and 4 anti-VEGF intravitreal injections for nAMD (faricimab, ranibizumab, bevacizumab, brolucizumab, or aflibercept) per standard of care within 6 months of Visit
- •History of response to prior intravitreal anti-VEGF treatment in the study eye.
- •ETDRS BCVA of between 20 and 80 letters (inclusive) in the study eye.
排除标准
- •ETDRS BCVA <20 letters in the study eye.
- •Central subfield thickness > 400 μm or retinal pigment epithelium detachment thickness >400 μm on SD-OCT in the study eye.
- •Subretinal hemorrhage, fibrosis or atrophy of >50% of the total lesion area and/or that involves the fovea on fundus fluorescein angiography and/or color fundus photography in the study eye.
- •CNV due to causes other than AMD, such are ocular histoplasmosis, trauma, pathological myopia, angioid streaks, choroidal rupture, or uveitis, in the study eye.
- •Any history of macular pathology unrelated to AMD affecting vision or contributing to the presence of intraretinal or subretinal fluid in the study eye.
研究组 & 干预措施
1.0 mg CLS-AX
Suprachoroidal injection of 10 mg/mL (1.0 mg in 0.1 mL) of CLS-AX
干预措施: CLS-AX (Drug)
Aflibercept
Intravitreal injection of aflibercept (2 mg in 0.05 mL)
干预措施: Aflibercept (Drug)
结局指标
主要结局
Evaluations of Outcomes Related to ETDRS BCVA in the Study Eye Over Time
时间窗: Baseline, Weeks 4, 12, 16, 20, 24, 28, 32 and 36
Best Corrected Visual Acuity (BCVA) letter score measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting test distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score attainable). An increase in BCVA letter score from baseline indicates an improvement in visual acuity.
次要结局
- Evaluations of Outcomes Related to Fluid Detected on Optical Coherence Tomography in the Study Eye Over Time(Baseline, Weeks 4, 12, 16, 20, 24, 28, 32 and 36)
- Evaluations of Outcomes Related to Lesion Size on Fundus Fluorescein Angiography in the Study Eye Over Time(Baseline, Week 36)
- Evaluation of the Number of Study Drug Injections and Supplemental Therapy Injections in the Study Eye Over Time(From Baseline Through Week 36)
- Evaluation of Serious Adverse Events (SAEs) and Treatment-Emergent Adverse Events (TEAEs)(From first dose of masked study drug through the end of the study (up to 36 weeks))