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OpenTrials
Completed

NCT Number: NCT04868916

An Observational Study of Japanese Participants With X-linked Retinitis Pigmentosa

The purpose of the study is to identify a cohort of Japanese participants with X-linked retinitis pigmentosa (XLRP) associated with pathogenic variants in the retinitis pigmentosa GTPase regulator (RPGR) gene and to investigate their associated phenotype.

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Key information

Conditions

X-Linked Retinitis Pigmentosa

Age range

5 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National Hospital Organization Tokyo Medical Center

Tokyo, 152 8902, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Have RPGR-associated retinal dystrophy
  • Are able to give informed consent or assent, with the guidance of their parent/guardian where appropriate
  • Are able to undertake age-appropriate clinical assessments as specified in the protocol

Exclusion criteria

  • Are unable or unwilling to undertake consent or clinical testing
  • Participated in another research study and had intraocular surgery within 3 months of screening
  • Significant ophthalmologic diseases

Treatment and study plan

Primary outcomes

  1. Visual Function

    Time frame: Up to Day 30

    Visual function will be assessed using visual acuity.

  2. Retinal Structure

    Time frame: Up to Day 30

    Retinal structure will be assessed using spectral domain optical coherence tomography (SDOCT).

  3. Retinal Function

    Time frame: Up to Day 30

    Retinal function will be assessed using static visual field testing.

Sponsors and collaborators

Lead sponsor

Janssen Pharmaceutical K.K.

Industry

Registry information

Official study title

Prospective Observational Study to Estimate the Genotype and Phenotype of Japanese Patients With X-linked Retinitis Pigmentosa Associated With Pathogenic Variants in Retinitis Pigmentosa GTPase Regulator (RPGR)

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
May 3, 2021
Registry last updated
Apr 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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