OHR-1601: A Phase III Study of the Efficacy and Safety of Squalamine Lactate Ophthalmic Solution, 0.2% Twice Daily in Subjects With Neovascular Age-Related Macular Degeneration (AMD)
试验速览
- 阶段
- 3 期
- 入组人数
- 230
- 试验地点
- 1
- 主要终点
- Functional change in visual acuity
研究概览
简要总结
A Phase 3 Study of the Efficacy and Safety of Squalamine Lactate Ophthalmic Solution 0.2% Twice Daily in Subjects with Neovascular Age-Related Macular Degeneration. Patients will receive injections of ranibizumab. In addition, patients will receive either Squalamine lactate 0.2% eye drops or Placebo eye drops. The study duration is approximately 9 months to primary endpoint
详细描述
Phase 3 Study of the Efficacy and Safety of Squalamine Lactate Ophthalmic Solution 0.2% Twice Daily in Subjects with Neovascular Age-Related Macular Degeneration Methodology: Phase III, multicenter, randomized, double-masked, placebo-controlled study conducted over 9 months
(Screening/Baseline to Week 36): Patients will be randomly assigned to one of 2 treatment groups in a 1:1 ratio:
- Squalamine lactate ophthalmic solution, 0.2% BID + ranibizumab every 4 weeks
- Placebo ophthalmic solution BID + monthly ranibizumab every 4 weeks
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
- 50 Years 至 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 50 years
- •A diagnosis of choroid neovascularization (CNV) secondary to AMD with CNV comprising at least 50% of the total lesion area on fluorescein angiography (FA)
- •Central subfield thickness (spectral domain (SD)-OCT central 1 mm) of ≥ 300 μm
- •Best-corrected visual acuity (BCVA) 20/40 to 20/320 (73- to 24-letter score on the Early Treatment of Diabetic Retinopathy Study [ETDRS] chart)
排除标准
- •Neovascularization secondary to any other condition than AMD in the study eye; Blood occupying greater than 50% of the AMD lesion, or blood > 1.0 sq. mm underlying the fovea
- •Pigment epithelial detachment (PED) without associated subretinal fluid and/or cystic retinal changes
- •Clinical evidence of diabetic retinopathy or diabetic macular edema in the study eye
- •Confounding ocular conditions in the study eye which will affect interpretation of OCT, VA or assessment of macular appearance (e.g., cataract, epiretinal membrane, retinal vascular occlusive disease)
- •Fibrosis or atrophy, retinal epithelial tear in the center of the fovea in the study eye or any condition preventing VA improvement
- •Uncontrolled glaucoma in the study eye, or currently receiving topical glaucoma medication in the study eye
研究组 & 干预措施
Squalamine solution, 0.2% BID
Squalamine lactate ophthalmic solution, 0.2% bis in die (BID) + ranibizumab every 4 weeks
干预措施: Squalamine lactate ophthalmic solution, 0.2% (Drug)
Squalamine solution, 0.2% BID
Squalamine lactate ophthalmic solution, 0.2% bis in die (BID) + ranibizumab every 4 weeks
干预措施: ranibizumab (Drug)
Placebo solution BID
Placebo ophthalmic solution BID + ranibizumab every 4 weeks
干预措施: Placebo Ophthalmic solution (Drug)
Placebo solution BID
Placebo ophthalmic solution BID + ranibizumab every 4 weeks
干预措施: ranibizumab (Drug)
结局指标
主要结局
Functional change in visual acuity
时间窗: 9 months
Effect of combination therapy of ranibizumab monthly intravitreal injections with Squalamine Lactate Ophthalmic Solution, 0.2% on change in visual function as assessed by ETDRS BCVA in subjects with Age-Related Macular Degeneration
次要结局
- Functional changes in visual acuity(9 months)