Retinitis Pigmentosa 11ReSaNCT04805658
Natural History Study of Retinitis Pigmentosa Type 11
An observational study of Retinitis Pigmentosa 11 and Retinitis Pigmentosa, run by Oslo University Hospital at 1 site in Norway.
Trial summary
Observational study of patients with retinitis pigmentosa type 11 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retinitis Pigmentosa 11, Retinitis Pigmentosa
- What is being tested?
- Clinical examinations
- How many people
- 30 participants
- Where
- 1 siteNorway
- Study dates
- 1 Feb 2021to 1 Apr 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients over the age of 18 with the clinical diagnosis of retinitis pigmentosa type 11 or asymptomatic carriers of the disease.
Who may be able to join
- 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
Who cannot join
- Under 18 years
- Other types of retinitis pigmentosa
Trial locations and contacts
1 site in 1 country.
About this study
Observational study of patients with retinitis pigmentosa type 11
Read the detailed description
Natural history study with clinical examination every 6 months.
- Conditions
- Retinitis Pigmentosa 11, Retinitis Pigmentosa
- Being tested
- Clinical examinations
- Keywords
- Retinitis, RP, PRPF31
- Medical subject headings
- Retinitis Pigmentosa 11, Retinitis Pigmentosa, Retinitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical examinationsDiagnostic test
Clinical examinations
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression of disease
Retinal function measured by functional and structural testing
Measured: 24 mounths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study start1 Feb 2021
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinitis Pigmentosa 11Studies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Josephine Prener Holtan, Oslo University Hospital
- Investigators
- Josephine P Holtan, MD, PHD, Principal investigator, Department of Ophthalmology, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04805658
- Sponsor's protocol ID
- 179417
- Acronym
- ReSa
- Status last verified
- Apr 2024
- First submitted
- 16 Mar 2021
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natural History Study of Retinitis Pigmentosa Type 11
- ClinicalTrials.gov ID
- NCT04805658
- Acronym / sponsor ID
- ReSa / 179417
- Conditions
- Retinitis Pigmentosa 11, Retinitis Pigmentosa
- Keywords
- Retinitis, RP, PRPF31
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 18 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Observational study of patients with retinitis pigmentosa type 11
Detailed description
Natural history study with clinical examination every 6 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients over the age of 18 with the clinical diagnosis of retinitis pigmentosa type 11 or asymptomatic carriers of the disease.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Under 18 years
- Other types of retinitis pigmentosa
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical examinationsClinical examinations | Diagnostic test | – |
Primary outcome
Progression of disease
Time frame: 24 mounths
Retinal function measured by functional and structural testing
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Josephine P Holtan, MD, PHD principal investigator
Department of Ophthalmology, Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Retinitis Pigmentosa 11 and Retinitis Pigmentosa, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression of disease (time frame: 24 mounths). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2025.