NCT06319872 - The Effects of Disulfiram (Antabuse®) on Visual Acuity in Patients With Retinal Degeneration | Crick

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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

Outcomes

Primary Outcomes

mean change in Best Corrected Visual Acuity (BCVA) score assessed by ETDRS

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.