NCT02153476已完成2 期
A Safety And Efficacy Study Of Alg-1001 In Human Subjects With Symptomatic Focal Vitreomacular Adhesion
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 5
- 主要终点
- Release of Vitreo Macular Adhesion (VMA) by Optical Coherence Tomography (OCT)
研究概览
简要总结
Evaluate the safety and efficacy of ophthalmic intravitreal injection of ALG-1001 in human subjects with symptomatic focal vitreomacular adhesion
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
- •Symptomatic focal vitreomacular adhesion
- •Vitreomacular traction syndrome
- •Stage 1 and 2 macular holes, ≤ 350 µm
- •BCVA of 20/25 Early Treatment Diabetic Retinopathy Study (ETDRS) or worse in the study eye
- •BCVA of 20/800 ETDRS or better in the fellow eye
- •Male or female subjects, 18 years of age or older
- •Signed Informed Consent
排除标准
- •High myopes > -8.0 D spherical equivalent
- •History of prior vitrectomy in the study eye
- •History of photocoagulation to the retina in the study eye
- •Macular hole in the study eye > 350 µm
- •Subjects with epiretinal membranes in the study eye
- •Subjects with broad VMA, defined as VMA of >1500 µm
- •Subjects with proliferative Diabetic Retinopathy (DR), neovascular Age-related Macular Degeneration (AMD), or retinal vascular occlusion in the study eye
- •Subjects with aphakia in the study eye
- •Subjects with uncontrolled glaucoma
- •Subjects with lenticular or zonular instability
- •Subjects with prior ocular surgery or intravitreal injection in the study eye within 90 days of study enrollment
- •Pregnant or nursing women
研究组 & 干预措施
2.0mg of ALG-1001
Experimental
2.0mg of ALG-1001
干预措施: 2.0mg of ALG-1001 (Drug)
Intravitreal injection in 0.05cc balanced salt solution.
Placebo Comparator
Balanced Salt Solution
干预措施: Balanced Salt Solution (Drug)
结局指标
主要结局
Release of Vitreo Macular Adhesion (VMA) by Optical Coherence Tomography (OCT)
时间窗: 90 Days
The primary endpoint of this study is observation of pharmacologic resolution of VMA, with VMA defined as vitreous adhesion to the macula within a 6mm central retinal field surrounded by elevation of the posterior vitreous cortex as seen on OCT.
次要结局
未报告次要终点
研究者
研究点 (5)
Loading locations...
相似试验
已完成
1 期
A Safety And Efficacy Study Of ALG-1001 In Human Subjects With Wet Age-Related Macular DegenerationMacular DegenerationNCT01749891Allegro Ophthalmics, LLC25
撤回
1 期
Safety Study of ALG- 1001 to Treat Diabetic Macular EdemaDiabetic Macular EdemaNCT01482871Allegro Ophthalmics, LLC
已完成
1 期
Study to Evaluate the Ocular Tolerance of SYL1001 in Healthy VolunteersOcular PainDry EyeNCT01438281Sylentis, S.A.30
已完成
1 期
Safety and Efficacy of AGN208397 in the Treatment of Macular Edema Associated With Retinal Vein Occlusion (RVO)Macular EdemaRetinal Vein OcclusionNCT01027650Allergan121
招募中
不适用
Long-term Follow-up Study of AL-001 Ophthalmic Injection in Subjects with WAMDWet Age-related Macular Degeneration (wAMD)NCT06718816Beijing Anlong Biopharmaceutical Co., Ltd.21