Phase II/III Study of the Efficacy and Safety of MacuCLEAR MC-1101 1.0% BID in the Treatment of Non-exudative Age-Related Macular Degeneration
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 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 non-exudative 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 Baseline, 1, 3, 6, 12,18 and 24 months.
详细描述
MC-1101is a topically administered drug which in previous clinical studies has been proven to get to the back of the eye. MC-1101is a 505 (b) 2 compound and has FDA Fast Track Status. It is a strong, vasoactive drug which is intended to increase choroidal blood flow.
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 only: At least 1year since last menstrual period or surgically sterilized
- •20/80 or better ETDRS best corrected visual acuity
- •Early to intermediate nonexudative AMD (AMD category 3 through 3b on Age-Related Eye Disease Study (AREDS) Report No. 8 AMD Categories
- •Willing and able to sign informed consent, comply with study protocol requirements, and undergo at least 2.5 hours of testing at each visit
- •Able to reliably to complete biophysical testing
- •Willing to take an AREDS2 based formula vitamin as indicated
排除标准
- •Past or current exudative AMD or central geographic atrophy in study eye; (AMD Category 4 on Age-Related Eye Disease Study (AREDS) Report No. 8 AMD Categories)
- •Past or current retinal or choroidal vasculopathy in study eye (e.g. serous or hemorrhagic pigment epithelial detachment, polypoidal choroidal vasculopathy, central serous chorioretinopathy, retinal vein occlusion, sickle cell retinopathy)
- •Uncontrolled hypertension (≥ 160 systolic or ≥95 diastolic)
- •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 small bowel surgery
- •Current or past use for more than 30 days of chloroquine, hydroxychloroquine, chlorpromazine, thioridazine, quinine sulfate, clofazimine, cisplatin, carmustine (BCNU), deferoxamine, amiodorone, isoretinoin, or gold
- •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 prior to screening visit of this study
- •Currently being treated for cancer or any disease likely to adversely affect participation in a 2 year study
- •Known to have AIDS/HIV
- •Current use of hydralazine
- •Any other findings deemed unacceptable by the Principal Investigator or Sponsor
研究组 & 干预措施
MC-1101 active
Topical Drug 1% Ophthalmic Solution Topically, two times per day; morning and bedtime
干预措施: MC-1101 (Drug)
MC-1101 Vehicle Control
Topical Drug:
Ophthalmic Solution Topically, two times per day; morning and bedtime
干预措施: MC-1101 Vehicle (Drug)
结局指标
主要结局
Visual Function
时间窗: Up to 24 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 measured by dark adaptation methodology.
次要结局
- Safety and tolerability (incidence and severity of adverse events, ocular irritability, ocular hyperemia)(Up to 24 months)