Age-Related Macular Degeneration (ARMD) Clinical Trials

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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• 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.

Locations
United States
New York
Flaum Eye Institute, University of Rochester Medical Center
RECRUITING
Rochester
Contact Information
Primary
Evan Burr
evan_burr@urmc.rochester.edu
585- 275-5234
Time Frame
Start Date: 2025-05-19
Estimated Completion Date: 2029-05-19
Participants
Target number of participants: 15
Treatments
Experimental: All participants
Participants will receive either drug or placebo for 180 days.
Related Therapeutic Areas
Late-Onset Retinal Degeneration
Retinitis Pigmentosa
Retinopathy Pigmentary Mental Retardation
Age-Related Macular Degeneration (ARMD)
Sponsors
Leads: University of Rochester

This content was sourced from clinicaltrials.gov

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