- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04805658
Natural History Study of Retinitis Pigmentosa Type 11 (ReSa)
March 23, 2023 updated by: Ragnheidur Bragadottir, Oslo University Hospital
Observational study of patients with retinitis pigmentosa type 11
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Natural history study with clinical examination every 6 months.
Study Type
Observational
Enrollment (Anticipated)
40
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Josephine P Holtan, MD
- Phone Number: +22118589
- Email: jospre@ous-hf.no
Study Locations
-
-
-
Oslo, Norway, 0450
- Recruiting
- Department of Ophthalmology, Oslo University Hospital
-
Contact:
- Josephine P Holtan, MD
- Phone Number: +4722118589
- Email: jospre@ous-hf.no
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
All patients over the age of 18 with the clinical diagnosis of retinitis pigmentosa type 11 or asymptomatic carriers of the disease.
Description
Inclusion Criteria:
- Clinical diagnosis of retinitis pigmentosa caused by a disease-causing mutation involving the PRPF31 gene
- Or disease-causing mutation involving the PRPF31 gene without the clinical diagnosis of retinitis pigmentosa
Exclusion Criteria:
- Under 18 years
- Other types of retinitis pigmentosa
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression of disease
Time Frame: 24 mounths
|
Retinal function measured by functional and structural testing
|
24 mounths
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ragnheidur Bragadottir, MD, PHD, Department of Ophthalmology, Oslo University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2021
Primary Completion (Anticipated)
July 1, 2023
Study Completion (Anticipated)
February 1, 2025
Study Registration Dates
First Submitted
March 16, 2021
First Submitted That Met QC Criteria
March 16, 2021
First Posted (Actual)
March 18, 2021
Study Record Updates
Last Update Posted (Actual)
March 27, 2023
Last Update Submitted That Met QC Criteria
March 23, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 179417
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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