NCT04805658

Brief Summary

Observational study of patients with retinitis pigmentosa type 11

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
23mo left

Started Feb 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress73%
Feb 2021Apr 2028

Study Start

First participant enrolled

February 1, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 16, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 18, 2021

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2028

Last Updated

March 21, 2025

Status Verified

April 1, 2024

Enrollment Period

7.2 years

First QC Date

March 16, 2021

Last Update Submit

March 18, 2025

Conditions

Retinitis Pigmentosa 11Retinitis Pigmentosa

Keywords

RetinitisRPPRPF31

Outcome Measures

Primary Outcomes (1)

  • Progression of disease

    Retinal function measured by functional and structural testing

    24 mounths

Interventions

Clinical examinationsDIAGNOSTIC_TEST

Clinical examinations

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • Under 18 years
  • Other types of retinitis pigmentosa

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ophthalmology, Oslo University Hospital

Oslo, 0450, Norway

Location

MeSH Terms

Conditions

Retinitis Pigmentosa 11Retinitis PigmentosaRetinitis

Interventions

Physical Examination

Condition Hierarchy (Ancestors)

Eye Diseases, HereditaryEye DiseasesRetinal DystrophiesRetinal DegenerationRetinal DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Josephine P Holtan, MD, PHD

    Department of Ophthalmology, Oslo University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Consultant, MD PhD

Study Record Dates

First Submitted

March 16, 2021

First Posted

March 18, 2021

Study Start

February 1, 2021

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

April 1, 2028

Last Updated

March 21, 2025

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)