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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Rochester

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • Oral disulfiram

    Drug

    250 mg/day

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: All participantsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

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