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

NCT ID: NCT04558983

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

32 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-11

Study Completion Date

2024-12-20

Brief Summary

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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.

Detailed Description

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Conditions

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Retinitis Pigmentosa

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Retinitis Pigmentosa

Patients with Retinitis Pigmentosa

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter A Campochiaro, M.D.

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Wilmer Eye Institute at Johns Hopkins University

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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IRB00227603

Identifier Type: -

Identifier Source: org_study_id