Natural History Study of Retinitis Pigmentosa Type 11 (ReSa)

March 18, 2025 updated by: Josephine Prener Holtan, Oslo University Hospital
Observational study of patients with retinitis pigmentosa type 11

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Natural history study with clinical examination every 6 months.

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 0450
        • Department of Ophthalmology, Oslo University Hospital

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

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

Oslo University Hospital

Investigators

  • Principal Investigator: Josephine P Holtan, 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 (Estimated)

April 1, 2028

Study Completion (Estimated)

April 1, 2028

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 25, 2025

Last Update Submitted That Met QC Criteria

March 18, 2025

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

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

product manufactured in and exported from the U.S.

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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