Anti-malarial drug
Hydroxychloroquine lower dose for Retinitis Pigmentosa
Phase 1 & 2
Recruiting
Led By David Zacks, MD
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Clinical diagnosis of autosomal dominant retinitis pigmentosa
Clinical diagnosis of autosomal dominant retinitis pigmentosa
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upscreening up to 18 months
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions
No Placebo-Only Group
Study Summary
This trial is testing whether the drug hydroxychloroquine can help people with retinitis pigmentosa by altering the autophagy pathway in photoreceptors.
Eligible Conditions
- Retinitis Pigmentosa
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You have been diagnosed with a type of genetic eye disease called autosomal dominant retinitis pigmentosa.
Select...
You have been diagnosed with a type of inherited eye condition called retinitis pigmentosa.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ screening up to 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~screening up to 18 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Ellipsoid zone area measured by Spectral-Domain Optical Coherence Tomography (SD-OCT)
Change in Retinal sensitivity (decibels) measured by scotopic and mesopic microperimetry
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: HCQ treatment 2Experimental Treatment1 Intervention
In treatment arm 2, the dose of the study drug will be 5 mg/kg/day. The daily dose will not exceed 400 mg. In both groups, the dose will be rounded down to 100, 200, 300, or 400 mg/day.
Group II: HCQ treatment 1Experimental Treatment1 Intervention
In treatment arm 1, the dose of study drug will be 4 mg/kg/day. The daily dose will not exceed 400 mg. In both groups, the dose will be rounded down to 100, 200, 300, or 400 mg/day.
Find a site
Who is running the clinical trial?
Cures Within ReachOTHER
19 Previous Clinical Trials
1,729 Total Patients Enrolled
1 Trials studying Retinitis Pigmentosa
4 Patients Enrolled for Retinitis Pigmentosa
University of MichiganLead Sponsor
1,718 Previous Clinical Trials
6,567,770 Total Patients Enrolled
3 Trials studying Retinitis Pigmentosa
563 Patients Enrolled for Retinitis Pigmentosa
David Zacks, MD2.04 ReviewsPrincipal Investigator - University of Michigan
University of Michigan
1Patient Review
Dr. Zacks is very dogmatic and inflexible in his thinking.
Media Library
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are enrollments still open for this investigation?
"As stated on clinicaltrials.gov, this medical investigation is presently enrolling volunteers. The trial was first announced on February 25th 2020 and the most recent update came out February 14th 2022."
Answered by AI
How many participants are currently enlisted in this clinical investigation?
"Affirmative. Clinicaltrials.gov provides evidence that this research project is recruiting participants, having been first posted on February 25th 2020 and most recently updated on February 14th 2022. The trial requires a total of twelve subjects from one site to participate."
Answered by AI
What conditions is a lower dose of Hydroxychloroquine typically prescribed for?
"Hydroxychloroquine lower dose is commonly used to treat malaria, as well as other ailments such as q fever, rheumatoid arthritis, and Sjögren's syndrome."
Answered by AI
Who else is applying?
What state do they live in?
Puerto Rico
Florida
Texas
How old are they?
18 - 65
What site did they apply to?
University of Michigan
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I am very happy for your clinical trial and i am hoping i can be one of your candidate i am ready to do whatever is necessary.
Patient
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