A Phase 1 interventional study of Oral disulfiram in Alcohol Use Disorder, Retinal Dystrophies and Age-Related Macular Degeneration, sponsored by University of Rochester. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by University of Rochester · Phase 1, Interventional, and Treatment
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.
1,674 studies on the registry are indexed under Alcoholism; 331 are open to participants now.
This study's planned enrollment of 15 is below the median of 88 across 1,428 interventional studies indexed under Alcoholism.
Browse Alcoholism studies →University of Rochester is the lead sponsor of 729 studies on the registry; 116 are open to participants now.
Of its 56 completed or terminated interventional studies of FDA-regulated products, 44 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive either drug or placebo for 180 days.
Drug: Oral disulfiram
250 mg/day
Also known as: Antabuse
mean change in Best Corrected Visual Acuity (BCVA) score assessed by ETDRS
Visual acuity testing will be performed by Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity with refractive correction when indicated under photopic and mesopic conditions. The test will be performed by an ophthalmic technician and will be used for research purpose only. The right eye should be tested first. When it becomes evident that no further meaningful readings can be made, the examiner should stop the test. The final visual acuity should be noted. Visual acuity is a range from 20/20 to Light Perception, where 20/20 is considered the normal best visual acuity measurement.
Time frame: baseline to day 180
mean change in total contrast sensitivity score using Pelli-Robson charts
Contrast sensitivity will be measured using Pelli-Robson charts with refractive correction where indicated. When it becomes evident that no further meaningful readings can be made, the examiner should stop the test. The results should be noted. The test will be performed by an ophthalmic technician and will be used for research purpose only. The Pelli-Robson score is a logarithmic measure of the subject's contrast sensitivity range from 0.05 to 2.3, where lower number indicates better sensitivity.
Time frame: baseline to day 180
mean change in light-adapted microperimetry sensitivity assessed using standard MAIA microperimetry equipment
Microperimetry is a technology that allows the study of retinal sensitivity at different foveal and parafoveal areas as well as eye fixation. A microperimeter projects light stimuli of different intensities to the retina to assess the sensitivity of each region and records the patient's responses to these stimuli. It is a technique of functional evaluation, providing a direct correlation between anatomical and functional outcomes. This test will be performed by a trained technician and will be used for research purpose only. The microperimetry sensitivity are given in threshold values in the range -1dB to 36dB, where higher value indicates better sensitivity. The dimensions of the zones of relative sensitivity will be qualitatively assessed where larger zones are better.
Time frame: baseline to day 180
mean change in outer retinal thickness assessed using Spectral Domain Optical Coherence Tomography (SD-OCT)
SD-OCT is a noninvasive interferometric method that provides high resolution imaging of the retina. Scans will include the macula and optic nerve. This test is part of the standard care for patients with retinal dystrophies and will be taken by a trained technician. The integrity of outer nuclear layer, ellipsoid zone and retinal pigment epithelium will be qualitatively assessed. The width of the outer nuclear layer and ellipsoid zone will be measured (mm) in the vertical and horizontal plane. Shrinking of this zone is indicative of worsened disease.
Time frame: baseline to day 180
mean change in fundus autofluorescence (FAF)
Fundus autofluorescence measures the intrinsic autofluorescence of lipofuscin and other molecules within the retinal pigment epithelium following excitation. This test is part of the standard care for patients with retinal dystrophies and will be performed by a trained technician. Fundus Autofluorescence will be qualitatively assessed for hypoautofluorescence indicating reduced retinal function and will measure in mm horizontal width of hyperfluorescent ring if present in macula.
Time frame: baseline to day 180
number of participants with retinal anatomy changes assessed using fundus photos
This is a non-invasive, non-contact procedure that should take approximately 5 minutes. Photos of the retina, including optic nerve and vessels will be taken by a trained technician. Fundus photographs will be qualitatively assessed for zones of atrophy, amount and distribution of pigment clumps, degree of vessels thinning and optic nerve head pallor. Any change in these areas will be counted as a participant with anatomy changes.
Time frame: baseline to day 180
mean change in visual field perimetry using full-field stimulus test
Full field stimulus testing measures the luminescence threshold for the visualization of a stimulus. The subject's pupils are dilated and varying narrow wavelengths of light at varying luminescence are presented to the subject. Full field testing will be completed only in subjects who are able to cooperate with this assessment and will be performed by a trained technician and will be used for research purpose only. Threshold results will be reported in the units of logcd.s.m-2 for brief stimulus, or in the units of logcd.m-2 with longer duration. Threshold results will be reported in the units of logcd.s.m-2 for brief stimulus, or in the units of logcd.m-2 with longer duration.
Time frame: baseline to day 180
mean change in isopter constriction using Goldmann visual field
This is a non-invasive, non-contact procedure that should take approximately 15-30 minutes where the subject responds to different light stimuli. Both eyes will be tested separately and will be performed by an ophthalmic technician. The extent of isopter constriction in degrees will be measured.
Time frame: baseline to day 180
mean change in size of scotomas using Goldmann visual field
This is a non-invasive, non-contact procedure that should take approximately 15-30 minutes where the subject responds to different light stimuli. Both eyes will be tested separately and will be performed by an ophthalmic technician. The location and size of any scotomas will be measure in mm.
Time frame: baseline to day 180
mean change in cone and rod latency assessed using Full field electroretinogram (ffERG)
The ffERG is a mass electrical response of the retina to photic stimulation. The basic method of recording the electrical response is by stimulating the eye with a various light source, to assess rod and cone function. Results are assessed using a contact lens with an imbedded electrode. The latency in ms will be assessed for 'a' and 'b' wave in both scotopic and photopic conditions. The longer the latency, the worse retinal function.
Time frame: baseline to day 180
mean change in cone and rod amplitude assessed using Full field electroretinogram (ffERG)
The ffERG is a mass electrical response of the retina to photic stimulation. The basic method of recording the electrical response is by stimulating the eye with a various light source, to assess rod and cone function. Results are assessed using a contact lens with an imbedded electrode. The amplitude in mV will be assessed for 'a' and 'b' wave in both scotopic and photopic conditions. Lower amplitude indicates worse retinal function.
Time frame: baseline to day 180
mean change in cone and rod latency assessed using multifocal electroretinogram (mfERG)
The mfERG allows assessment of ERG activity in small areas of retinal dysfunction, such as the macular area. A bipolar Burian speculum contact is used. The trace arrays, 3D-response density plot and Ring-average will be assessed. The spatial variations in the responses will be assessed, where delay in latency indicates poorer response.
Time frame: baseline to day 180
mean change in cone and rod amplitude assessed using multifocal electroretinogram (mfERG)
The mfERG allows assessment of ERG activity in small areas of retinal dysfunction, such as the macular area. A bipolar Burian speculum contact is used. The trace arrays, 3D-response density plot and Ring-average will be assessed. The spatial variations in the responses will be assessed, where reduced amplitude indicates poorer response.
Time frame: baseline to day 180
mean change in National Eye Institute-Visual Functioning Questionnaire 25 composite score.
The visual questionnaire will access general health, and vision problems, including photopsias. An adapted version of the Visual Functioning Questionnaire - 25 (VFQ-25). will be used. If the patient is comfortable and able to read it, he/she can answer the questions by his/her own. Electronic version will also be available for patients to use zoom text or contrast adjustment when needed. If the subject can't read the questionnaire, the investigator will assist her/him it will be read to the subject by a clinic staff. The score ranges from 0-100 with higher scores indicating better outcomes.
Time frame: baseline to day 180
Plan to share: No
No publications or documents are linked to this record.
Started May 2025 (actual). Primary completion is estimated for May 2029, 48 months after the start.
Of 63 non-industry phase 1 interventional studies under Alcoholism, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 49. This study's planned 48 months is above that.
Counting every sponsor, half of 75 studies reached it within 28 months; a quarter within 19 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Disulfiram