Phase
Condition
Substance Abuse
Alcohol Dependence
Retinitis Pigmentosa
Treatment
Oral disulfiram
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 theduration of the study.
In good general health as evidenced by medical history and with a clinical diagnosisof inherited retinal dystrophy or dry-AMD.
Best Corrected Visual Acuity (BCVA) of 20/20 (with constriction or other defects ofGoldmann visual field) to Light Perception in the better eye.
Intact inner nuclear layer, inner plexiform, and ganglion cell layer on macularSD-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 addictionspecialist 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 urinepregnancy test at screening.
Any female participant of childbearing potential must have (or have a partner whohas) had a surgical sterilization (vasectomy, hysterectomy, or tubal ligation), becompletely abstinent from intercourse or must agree to practice two acceptablemethods of contraception throughout the course of the study and for at least oneweek after disulfiram discontinuation. Acceptable methods of contraception includehormonal contraception (i.e., birth control pills, injected hormones, dermal patch,or vaginal ring); intrauterine device; barrier methods (diaphragm, condom) withspermicide.
Exclusion
Exclusion Criteria:
A condition that, in the opinion of the investigator, would preclude participationin 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 contactdermatitis.
Those on anticoagulant therapy or other medications that may be affected bydisulfiram.
Ophthalmic conditions with independent effect upon visual function (e.g. diabeticretinopathy, glaucoma, cataract, vitreous hemorrhage, retinal detachment, activeintraocular inflammation or active infectious ocular diseases, choroidalneovascularization).
Patients with No Light Perception (NLP) in both eyes.
History of major ocular surgery within the prior 6 months or major ocular surgeryanticipated 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 drugwithin 30 days of randomization that has not received regulatory approval at thetime of study entry. Note: study participants cannot receive another investigationaldrug 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 becomepregnant within the next 12 months.
Participants who expect to move out of the area of the clinical center during the 8months of the study
Study Design
Connect with a study center
Flaum Eye Institute, University of Rochester Medical Center
Rochester, New York 14642
United StatesActive - Recruiting
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