NCT06319872招募中1 期
The Effects of Disulfiram on Visual Acuity in Patients With Retinal Degeneration
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- mean change in Best Corrected Visual Acuity (BCVA) score assessed by ETDRS
研究概览
简要总结
Oral disulfiram (Antabuse®) has been shown to improve image-forming vision in animal models with retinal degeneration due to its ability to decrease Retinoic Acid synthesis and consequently reduce hyperactivity in the inner retina. The investigator will aim to evaluate the impact of oral disulfiram on the vision of patients with retinal degeneration who are being treated with the drug in the management of their concurrent alcohol use disorder.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
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
- •All sexes, 18 years and older.
- •Participants must speak English, understand, and sign the informed consent document.
- •Stated willingness to comply with all study procedures and availability for the duration of the study.
- •In good general health as evidenced by medical history and with a clinical diagnosis of inherited retinal dystrophy or dry-AMD.
- •Best Corrected Visual Acuity (BCVA) of 20/20 (with constriction or other defects of Goldmann visual field) to Light Perception in the better eye.
- •Intact inner nuclear layer, inner plexiform, and ganglion cell layer on macular SD-OCT.
- •Ability to take oral medication and be willing to adhere to the disulfiram regimen.
- •Patients must have the diagnosis of alcohol use disorder provided by an addiction specialist and be a candidate for therapeutic use of disulfiram for that condition.
- •Patients must agree to refrain from all alcohol consumption for 180 days.
- •Any female participant of childbearing potential must have a negative urine pregnancy test at screening.
- •Any female participant of childbearing potential must have (or have a partner who has) had a surgical sterilization (vasectomy, hysterectomy, or tubal ligation), be completely abstinent from intercourse or must agree to practice two acceptable methods of contraception throughout the course of the study and for at least one week after disulfiram discontinuation. Acceptable methods of contraception include hormonal contraception (i.e., birth control pills, injected hormones, dermal patch, or vaginal ring); intrauterine device; barrier methods (diaphragm, condom) with spermicide.
排除标准
- •A condition that, in the opinion of the investigator, would preclude participation in the study, e.g., cardiovascular disease, hepatitis.
- •Individuals with a history of diabetes mellitus.
- •Individuals with a history of psychosis.
- •Individuals with hypothyroidism.
- •Individuals with hypersensitivity to thiuram derivatives causing rubber contact dermatitis.
- •Those on anticoagulant therapy or other medications that may be affected by disulfiram.
- •Ophthalmic conditions with independent effect upon visual function (e.g. diabetic retinopathy, glaucoma, cataract, vitreous hemorrhage, retinal detachment, active intraocular inflammation or active infectious ocular diseases, choroidal neovascularization).
- •Patients with No Light Perception (NLP) in both eyes.
- •History of major ocular surgery within the prior 6 months or major ocular surgery anticipated within the next 6 months following randomization.
- •Exam evidence of severe external ocular infection, including conjunctivitis, chalazion, or substantial blepharitis
- •Participation in an investigational trial that involves treatment with any drug within 30 days of randomization that has not received regulatory approval at the time of study entry. Note: study participants cannot receive another investigational drug while participating in this study.
- •Known allergy or hypersensitivity to any component of the study drug.
- •For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 12 months.
- •Participants who expect to move out of the area of the clinical center during the 8 months of the study
研究组 & 干预措施
All participants
Experimental
Participants will receive either drug or placebo for 180 days.
干预措施: Oral disulfiram (Drug)
结局指标
主要结局
mean change in Best Corrected Visual Acuity (BCVA) score assessed by ETDRS
时间窗: baseline to day 180
Visual acuity testing will be performed by Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity with refractive correction when indicated under photopic and mesopic conditions. The test will be performed by an ophthalmic technician and will be used for research purpose only. The right eye should be tested first. When it becomes evident that no further meaningful readings can be made, the examiner should stop the test. The final visual acuity should be noted. Visual acuity is a range from 20/20 to Light Perception, where 20/20 is considered the normal best visual acuity measurement.
次要结局
- mean change in total contrast sensitivity score using Pelli-Robson charts(baseline to day 180)
- mean change in light-adapted microperimetry sensitivity assessed using standard MAIA microperimetry equipment(baseline to day 180)
- mean change in outer retinal thickness assessed using Spectral Domain Optical Coherence Tomography (SD-OCT)(baseline to day 180)
- mean change in fundus autofluorescence (FAF)(baseline to day 180)
- number of participants with retinal anatomy changes assessed using fundus photos(baseline to day 180)
- mean change in cone and rod latency assessed using multifocal electroretinogram (mfERG)(baseline to day 180)
- mean change in visual field perimetry using full-field stimulus test(baseline to day 180)
- mean change in isopter constriction using Goldmann visual field(baseline to day 180)
- mean change in size of scotomas using Goldmann visual field(baseline to day 180)
- mean change in cone and rod latency assessed using Full field electroretinogram (ffERG)(baseline to day 180)
- mean change in National Eye Institute-Visual Functioning Questionnaire 25 composite score.(baseline to day 180)
- mean change in cone and rod amplitude assessed using Full field electroretinogram (ffERG)(baseline to day 180)
- mean change in cone and rod amplitude assessed using multifocal electroretinogram (mfERG)(baseline to day 180)
研究者
Alex Levin
Chief, Pediatric Ophthalmology and Ocular Genetics
University of Rochester
研究点 (1)
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