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New treatment option for Inherited Retinal Dystrophy Primarily Involving Sensory Retina
Official title Disulfiram for Treatment of Retinal Degeneration
ClinicalTrials.gov ID: NCT05626920
What this study is testing
What is Disulfiram 250 mg?
Disulfiram 250 mg is an investigational medicine, being studied as a potential treatment for inherited retinal dystrophy primarily involving sensory retina.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Aberrant retinoic acid signaling driven by the degenerating outer retina leads to pathological changes to the inner retina. The resulting hyperactivity of retinal ganglion cells leads to further diminution of the remaining vision in those afflicted with inherited retinal diseases.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥18 years Only those with a clinical diagnosis of inherited retinal degeneration. When available, supporting genetic diagnosis form a CLIA...
- Best corrected ETDRS visual acuity letter score ≥ 70 (i.e., 20/40 or better) within 30 days of enrollment.
- Goldmann visual field exhibiting constriction of visual fields to 10 degrees centrally
- Able and willing to provide informed consent
- Willing and able to abstain from alcohol consumption for the duration of the study and the 2 weeks preceding it and 2 weeks following the study end...
You likely can't join if
- A condition that, in the opinion of the investigator, would preclude participation in the study, e.g., alcohol dependence, cardiovascular disease...
- Individuals with a history of diabetes mellitus
- Individuals with a history of psychosis
- Individuals with hypothyroidism
- Individuals with hypersensitivity to thiuram derivatives causing rubber contact dermatitis
- Those on anticoagulant therapy or other medications that may be affected by disulfiram.
See the full eligibility criteria
- Age ≥18 years Only those with a clinical diagnosis of inherited retinal degeneration. When available, supporting genetic diagnosis form a CLIA approved lab will be further considered for inclusion. Only one eye per...
- Best corrected ETDRS visual acuity letter score ≥ 70 (i.e., 20/40 or better) within 30 days of enrollment.
- Goldmann visual field exhibiting constriction of visual fields to 10 degrees centrally
- Able and willing to provide informed consent
- Willing and able to abstain from alcohol consumption for the duration of the study and the 2 weeks preceding it and 2 weeks following the study end point Liver function values that fall in the normal range as specified...
- Alanine transaminase (ALT): less than 40 IU/L
- Aspartate transaminase (AST): less than 40 IU/L
- Alkaline phosphatase (ALP): less than 300 IU/L
- Albumin (Alb): less than 50 g/L
- Total Protein: less than 80 g/L
- Total Bilirubin: less than 30 umol/L
- A condition that, in the opinion of the investigator, would preclude participation in the study, e.g., alcohol dependence, cardiovascular disease, hepatitis.
- Individuals with a history of diabetes mellitus
- Individuals with a history of psychosis
- Individuals with hypothyroidism
- Individuals with hypersensitivity to thiuram derivatives causing rubber contact dermatitis
- Those on anticoagulant therapy or other medications that may be affected by disulfiram.
- An ocular condition, other than inherited retinal degeneration, is present such that, in the opinion of the investigator, visual acuity might be affected (e.g., foveal atrophy, pigment abnormalities, dense subfoveal...
- History of major ocular surgery within the prior 6 months or major ocular surgery anticipated within the next 6 months following randomization.
- Exam evidence of severe external ocular infection, including conjunctivitis, chalazion, or substantial blepharitis
- Participation in an investigational trial that involves treatment with any drug within 30 days of randomization that has not received regulatory approval at the time of study entry. Note: study participants cannot...
- Known allergy or hypersensitivity to any component of the study drug.
- For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 12 months. Women who are potential study participants should be questioned about the potential for pregnancy...
- Participants who expect to move out of the area of the clinical center during the 8 months of the study
The study team makes the final eligibility decision.
Where it's taking place
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seattle, Washington, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.