A Natural History Study to Evaluate Functional and Anatomical Progression in Retinitis Pigmentosa

  • STATUS
    Recruiting
  • End date
    Dec 20, 2024
  • participants needed
    130
  • sponsor
    Johns Hopkins University
Updated on 20 September 2023
other disease

Summary

This study will assess the progression of RP as seen on newer modalities including spectral-domain optical coherence (SD-OCT) and macular assessment integrity (MAIA) microperimetry to evaluate disease status. Understanding the natural history of the disease is not only essential to monitoring and comparing patient populations in clinical trials. It is also fundamental in the predevelopment phase in order to optimize the study duration needed to observe a statistically significant outcome. Furthermore, since the progression of RP is usually slow, relying on traditional tests can take an unfeasible length of time to observe any meaningful changes and assess therapeutic efficacy for new drugs. Therefore, the results of this study will be beneficial in establishing reliable endpoints and outcome measures for future clinical trials. Such outcome measures may be able to detect treatment response with more precision. More importantly, investigators may be able to detect changes early enough to prevent irreversible vision loss.

Details
Condition Retinitis Pigmentosa
Clinical Study IdentifierNCT04558983
SponsorJohns Hopkins University
Last Modified on20 September 2023

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 18 years or older
Patients diagnosed with Retinitis Pigmentosa
Ability to provide informed consent
Ability to authorize use and disclosure of protected health information

Exclusion Criteria

Concomitant ocular pathology that limits central macular function, including but not limited to age-related macular degeneration, diabetic retinopathy, and retinal vein occlusion
If EZ width ≤200µm
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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