Actively Recruiting
The Effects of Disulfiram on Visual Acuity in Patients With Retinal Degeneration
Led by University of Rochester · Updated on 2025-09-29
15
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effects of oral disulfiram (Antabuse4) on vision in patients with retinal degeneration who also have alcohol use disorder. This Phase 1 trial aims to evaluate whether disulfiram can improve visual acuity by decreasing Retinoic Acid synthesis and reducing retinal hyperactivity. The study is sponsored by the University of Rochester and focuses on patients diagnosed with inherited retinal dystrophy or dry age-related macular degeneration (AMD). Participants must also be candidates for disulfiram treatment for their alcohol use disorder. Participants will receive either oral disulfiram at a dose of 250 mg per day or a placebo for 180 days. The study is not blinded, meaning participants and researchers know which treatment is given. The trial will compare changes in vision and retinal health between the groups over the 180-day treatment period. Key measurements include visual acuity, contrast sensitivity, retinal thickness, and other specialized eye tests. During the study, participants will undergo regular assessments including eye exams, imaging tests such as Spectral Domain Optical Coherence Tomography (SD-OCT), and visual function questionnaires. Researchers will measure changes from baseline to day 180 in vision scores, retinal structure, and retinal response tests. Participants must adhere to the medication regimen and avoid alcohol during the study. Safety and vision will be closely monitored throughout the trial, which lasts about six months in total.
CONDITIONS
Brief Title
The Effects of Disulfiram (Antabuse®) on Visual Acuity in Patients With Retinal Degeneration
Who Can Participate
Eligibility Criteria
You may qualify if you...
- All sexes, 18 years and older
- Able to speak English, understand, and sign the informed consent
- Willing and available to comply with study procedures for the study duration
- In good general health with a clinical diagnosis of inherited retinal dystrophy or dry age-related macular degeneration
- Best Corrected Visual Acuity (BCVA) ranging from 20/20 to Light Perception in the better eye
- Intact inner retina layers on macular SD-OCT imaging
- Able to take oral medication and willing to follow the disulfiram regimen
- Diagnosed with alcohol use disorder by an addiction specialist and a candidate for disulfiram treatment
- Agree to avoid all alcohol for 180 days
- For females of childbearing potential: negative pregnancy test at screening
- For females of childbearing potential: must have surgical sterilization, be abstinent, or use two acceptable contraception methods during and one week after the study
You will not qualify if you...
- Any condition that would prevent study participation (e.g., cardiovascular disease, hepatitis)
- History of diabetes mellitus
- History of psychosis
- History of hypothyroidism
- Hypersensitivity to thiuram derivatives causing rubber contact dermatitis
- Use of anticoagulant therapy or medications affected by disulfiram
- Eye conditions affecting vision independently (e.g., diabetic retinopathy, glaucoma, cataract, retinal detachment, active eye infections)
- No Light Perception in both eyes
- Major eye surgery within 6 months before or planned within 6 months after enrollment
- Severe external eye infections (e.g., conjunctivitis, chalazion, blepharitis)
- Participation in another investigational drug trial within 30 days prior
- Allergy to any component of the study drug
- Pregnant, lactating, or intending pregnancy within 12 months for women of childbearing potential
- Planning to move away from the study area during the 8-month study period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 180 days
Participants receive oral disulfiram or placebo daily as treatment for retinal degeneration.
Visits scheduled as per protocol during treatment period
Trial Site Locations
Total: 1 location
1
Flaum Eye Institute, University of Rochester Medical Center
Rochester, New York, United States, 14642
Actively Recruiting
Research Team
E
Evan Burr
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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