The Effects of Disulfiram (Antabuse®) on Visual Acuity in Patients with Retinal Degeneration

Launched by UNIVERSITY OF ROCHESTER · Mar 18, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called disulfiram (commonly known as Antabuse®) on vision in patients with certain eye conditions that cause vision loss, such as retinal degeneration. Researchers believe that disulfiram may help improve vision by reducing certain chemical activities in the retina that can lead to visual problems. The trial is specifically looking for patients who also have alcohol use disorder, as disulfiram is typically used to help with this condition.

To participate, individuals must be 18 years or older, speak and understand English, and be in good general health with a specific eye condition. They need to have a certain level of vision, be able to take oral medication, and agree to avoid alcohol for 180 days. Participants will follow the study procedures for about eight months, during which they will take disulfiram and attend regular check-ups to monitor their vision and overall health. It's important to note that some individuals, such as those with specific health issues or recent eye surgeries, may not be eligible to participate. This trial provides an opportunity for patients to potentially benefit from a new treatment while contributing to important research on vision and eye health.

Gender

ALL

Eligibility criteria

• 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