NCT01601483终止2 期
Phase II/III Study of the Efficacy and Safety of Macuclear MC-1101 1% TID in the Treatment of Nonexudative Age-Related Macular Degeneration
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Visual Function
研究概览
简要总结
This is a Phase II/III vehicle controlled, double masked, single center study. A single eye of 60 individuals with mild to moderate nonexudative Age-Related Macular Degeneration (AMD) will be randomly assigned to receive either topical 1% MC-1101 or a vehicle control over 2 years. The study design will assess the efficacy, safety, and tolerability of MC-1101 for these patients.
An analysis of the primary and secondary endpoints will be conducted when all subjects have completed 12, 18 and 24 months.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females age ≥ 50 years and ≤ 85 years;
- •Females must be at least 1 year postmenopausal (after last menstrual period) or sterilized;
- •Better than 20/80 ETDRS best corrected visual acuity;
- •Mild to moderate nonexudative AMD (AMD steps 3 through 8 on Age-Related Eye Disease Study (AREDS) Report No. 17 grading scale);
- •Willing to sign informed consent, comply with study protocol requirements, and undergo up to 2.5 hours of testing at each visit;
排除标准
- •Past or current exudative AMD or any geographic atrophy (on fundus autofluorescence) in study eye;
- •Past or current other retinal or choroidal vasculopathy in study eye (e.g. pigment epithelial detachment, polypoidal choroidal vasculopathy, central serous retinopathy, retinal vein occlusion, sickle cell retinopathy);
- •Uncontrolled hypertension (≥ 150 systolic or ≥95 diastolic);
- •Diabetes mellitus;
- •Glaucoma;
- •Lens opacity ≥ grade 3 ARLNS on standard photographs;
- •Unable to complete biophysical testing;
- •Unable to give informed consent;
- •Dilated pupil diameter less than 6 millimeters;
- •Subjects with a history of a hypersensitivity reaction to the study drug or to any agent used in the components of the study assessment;
- •Use of topical ocular medications (other than artificial tear products);
- •Anticipated extra- or intraocular intervention during the study period;
- •High myopia (refractive error spherical equivalent ≥ -6 diopters);
- •Optic neuropathy;
- •Neurological conditions that can impair vision (e.g. Parkinson's disease, multiple sclerosis, Alzheimer's disease);
- •Liver disease (e.g. cirrhosis, hepatitis);
- •History of GI surgery (e.g. bariatric surgery);
- •Unwilling or unable to take an AREDS formula vitamin (without beta-carotene/vitamin A);
- •Current or past use of chloroquine, hydroxychloroquine, chlorpromazine, thioridazine, quinine sulfate, clofazimine, cisplatin, carmustine (BCNU), or deferoxamine;
- •Tobacco smoking (currently or within past 5 years);
- •Contact lens wearers (not prepared to discontinue lens use);
- •Ophthalmic surgery of any kind within 3 months prior to screening visit;
- •Participation in any interventional clinical study requiring IRB approval within 3 months of enrollment;
- •Currently being treated for cancer or any disease likely to adversely affect participation in a 2 year study;
- •Known to have AIDS/HIV
研究组 & 干预措施
MC-1101 1% Ophthalmic Solution
Experimental
干预措施: MC-1101 (Drug)
Vehicle control
Placebo Comparator
干预措施: MC-1101 Vehicle (Drug)
结局指标
主要结局
Visual Function
时间窗: 12 months
Primary efficacy assessment will be a comparison between groups of the change in visual function at 12 months with additional analyses at 18 and 24 months.
次要结局
- Safety and Tolerability (incidence and severity of adverse events, ocular irritability, ocular hyperemia)(24 months)
研究者
研究点 (1)
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