RECRUITING

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

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Conditions

Alcohol Use DisorderRetinal DystrophiesAge-Related Macular DegenerationRetinitis PigmentosaStargardt Disease

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

The Effects of Disulfiram on Visual Acuity in Patients With Retinal Degeneration

Quick Facts

Study Start:2025-05-19
Study Completion:2029-05-19
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06319872

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * All sexes, 18 years and older.
  2. * Participants must speak English, understand, and sign the informed consent document.
  3. * Stated willingness to comply with all study procedures and availability for the duration of the study.
  4. * In good general health as evidenced by medical history and with a clinical diagnosis of inherited retinal dystrophy or dry-AMD.
  5. * Best Corrected Visual Acuity (BCVA) of 20/20 (with constriction or other defects of Goldmann visual field) to Light Perception in the better eye.
  6. * Intact inner nuclear layer, inner plexiform, and ganglion cell layer on macular SD-OCT.
  7. * Ability to take oral medication and be willing to adhere to the disulfiram regimen.
  8. * 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.
  9. * Patients must agree to refrain from all alcohol consumption for 180 days.
  10. * Any female participant of childbearing potential must have a negative urine pregnancy test at screening.
  11. * 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.
  1. * A condition that, in the opinion of the investigator, would preclude participation in the study, e.g., cardiovascular disease, hepatitis.
  2. * Individuals with a history of diabetes mellitus.
  3. * Individuals with a history of psychosis.
  4. * Individuals with hypothyroidism.
  5. * Individuals with hypersensitivity to thiuram derivatives causing rubber contact dermatitis.
  6. * Those on anticoagulant therapy or other medications that may be affected by disulfiram.
  7. * 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).
  8. * Patients with No Light Perception (NLP) in both eyes.
  9. * History of major ocular surgery within the prior 6 months or major ocular surgery anticipated within the next 6 months following randomization.
  10. * Exam evidence of severe external ocular infection, including conjunctivitis, chalazion, or substantial blepharitis
  11. * 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.
  12. * Known allergy or hypersensitivity to any component of the study drug.
  13. * For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 12 months.
  14. * Participants who expect to move out of the area of the clinical center during the 8 months of the study

Contacts and Locations

Study Contact

Evan Burr
CONTACT
585- 450-9651
evan_burr@urmc.rochester.edu

Study Locations (Sites)

Flaum Eye Institute, University of Rochester Medical Center
Rochester, New York, 14642
United States

Collaborators and Investigators

Sponsor: University of Rochester

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-19
Study Completion Date2029-05-19

Study Record Updates

Study Start Date2025-05-19
Study Completion Date2029-05-19

Terms related to this study

Additional Relevant MeSH Terms

  • Alcohol Use Disorder
  • Retinal Dystrophies
  • Age-Related Macular Degeneration
  • Retinitis Pigmentosa
  • Stargardt Disease