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Anti-malarial drug
Hydroxychloroquine 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
Confirmed to have one copy of the P23H-RHO pathogenic variant by genetic testing at a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory
Clinical diagnosis of autosomal dominant retinitis pigmentosa
Timeline
Screening 3 weeks
Treatment Varies
Follow Up screening up to 18 months
Awards & highlights
Study Summary
This trial is testing whether the drug hydroxychloroquine can help people with retinitis pigmentosa by altering the autophagy pathway in photoreceptors.
Who is the study for?
This trial is for individuals with autosomal dominant retinitis pigmentosa caused by P23H-RHO. Participants must have a certain level of visual acuity, agree to use effective contraception if applicable, and be able to swallow pills whole. They should not have used specific drugs that affect the retina or have allergies to hydroxychloroquine or similar medications.Check my eligibility
What is being tested?
The study tests two doses of oral hydroxychloroquine (HCQ) over 12 months on people with retinitis pigmentosa to see if it can stop the progression of retinal degeneration. It involves six visits including one phone visit, where patients will undergo general exams, blood work, electrocardiograms, and special retina testing.See study design
What are the potential side effects?
Potential side effects may include digestive issues, changes in blood counts leading to anemia or bleeding problems, eye toxicity affecting vision, muscle weakness or nerve pain. There's also a risk of heart-related side effects like abnormal heart rhythms.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My genetic test shows I have the P23H-RHO variant.
Select...
I have been diagnosed with a genetic form of retinitis pigmentosa.
Select...
I can take pills as required and follow the medication schedule.
Select...
I can swallow pills whole and will follow the daily medication plan.
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
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.
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Who is running the clinical trial?
Cures Within ReachOTHER
19 Previous Clinical Trials
1,731 Total Patients Enrolled
1 Trials studying Retinitis Pigmentosa
4 Patients Enrolled for Retinitis Pigmentosa
University of MichiganLead Sponsor
1,796 Previous Clinical Trials
6,377,944 Total Patients Enrolled
3 Trials studying Retinitis Pigmentosa
528 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not taking any medications known to affect heart rhythm.My genetic test shows I have the P23H-RHO variant.I haven't had any experimental treatments for retinitis pigmentosa in the last 3 months.I have been diagnosed with a genetic form of retinitis pigmentosa.I am willing and able to follow the study's procedures and be available for its duration.I have no history of heart, kidney, liver, blood diseases, psoriasis, porphyria, or alcoholism.My eyes can be clearly examined and imaged.I can take pills as required and follow the medication schedule.I can swallow pills whole and will follow the daily medication plan.My blood tests show liver issues or kidney problems, or I have a blood disorder.I am not taking drugs like digoxin, antiepileptics, or methotrexate that can't be stopped.I am not allergic to hydroxychloroquine or similar medications, and I don't have a glucose-6-phosphate dehydrogenase deficiency.I have used tamoxifen before.
Research Study Groups:
This trial has the following groups:- Group 1: HCQ treatment 1
- Group 2: HCQ treatment 2
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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.
PatientReceived 1 prior treatment
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