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Anti-alcoholism Medication
Disulfiram for Retinal Degeneration
Phase 1
Recruiting
Research Sponsored by University of Rochester
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to day 180
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to see if a drug called disulfiram, commonly known as Antabuse, can improve vision in patients with retinal degeneration who also have an alcohol use disorder. The drug
Who is the study for?
This trial is for patients with various types of retinal degeneration, such as Stargardt Disease and Age-Related Macular Degeneration. Participants must also be receiving disulfiram for alcohol use disorder management. Specific inclusion and exclusion criteria details are not provided.
What is being tested?
The study is testing the effects of oral disulfiram (Antabuse®) on improving vision in patients with retinal degeneration. It's based on findings that it may reduce hyperactivity in the retina by decreasing Retinoic Acid synthesis.
What are the potential side effects?
While specific side effects related to this trial aren't listed, common side effects of disulfiram can include drowsiness, headache, metallic taste, skin rash, and in some cases more severe reactions like liver problems.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to day 180
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to day 180
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
mean change in Best Corrected Visual Acuity (BCVA) score assessed by ETDRS
Secondary study objectives
mean change in National Eye Institute-Visual Functioning Questionnaire 25 composite score.
mean change in cone and rod amplitude assessed using Full field electroretinogram (ffERG)
mean change in cone and rod amplitude assessed using multifocal electroretinogram (mfERG)
+10 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: All participantsExperimental Treatment1 Intervention
Participants will receive either drug or placebo for 180 days.
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Who is running the clinical trial?
University of RochesterLead Sponsor
872 Previous Clinical Trials
550,087 Total Patients Enrolled