A Study of Safety, Functional and Anatomical Effect of Squalamine Lactate Ophthalmic Solution, 0.2% Administered Twice Daily in Subjects With Neovascular Age-related Macular Degeneration
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Effect of combination therapy of ranibizumab monthly intravitreal injections with Squalamine Lactate Ophthalmic Solution, 0.2% on anatomy and function as assessed by retinal imaging and ETDRS BCVA in subjects with Age-Related Macular Degeneration
研究概览
简要总结
The purpose of this study is to evaluate anatomical and functional effect of combination therapy of Squalamine Lactate Ophthalmic Solution, 0.2% administered twice daily with monthly ranibizumab intravitreal injections in patients with choroidal neovascularization due to AMD.
详细描述
Subjects with age-related macular degeneration who meet inclusion and exclusion criteria will be randomized to receive monthly intravitreal injections of ranibizumab (Lucentis®) with either Squalamine Lactate Ophthalmic solution 0.2% or placebo eye drops twice a day for 6 months. Subjects will be evaluated with clinical and imaging techniques.
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
- Double (Participant, Investigator)
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
- •50 years of age or older
- •A diagnosis of choroidal neovascularization secondary to age-related macular degeneration (AMD) with choroidal neovascularization (CNV) comprising at least 50% of the total lesion area in the study eye
- •Central retinal thickness ≥ 300 μm and presence of subretinal fluid or cystoid edema by Optical Coherence Tomography (OCT)
- •Best Corrected Visual Acuity (BCVA) of 20/40 to 20/320 by Early Treatment Diabetic Retinopathy Study (ETDRS) Protocol
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
- •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
Placebo
Monthly intravitreal ranibizumab plus Placebo Ophthalmic solution
干预措施: Placebo Ophthalmic Solution (Drug)
Placebo
Monthly intravitreal ranibizumab plus Placebo Ophthalmic solution
干预措施: ranibizumab (Drug)
Active
Monthly intravitreal ranibizumab plus Squalamine Lactate Ophthalmic solution 0.2%
干预措施: Squalamine Lactate Ophthalmic Solution, 0.2% (Drug)
Active
Monthly intravitreal ranibizumab plus Squalamine Lactate Ophthalmic solution 0.2%
干预措施: ranibizumab (Drug)
结局指标
主要结局
Effect of combination therapy of ranibizumab monthly intravitreal injections with Squalamine Lactate Ophthalmic Solution, 0.2% on anatomy and function as assessed by retinal imaging and ETDRS BCVA in subjects with Age-Related Macular Degeneration
时间窗: 6 months
次要结局
未报告次要终点