Prospective Exploratory Cohort Study on Ganglion Cell Degeneration in Retinitis Pigmentosa Patients

NCT ID: NCT07056738

Last Updated: 2025-07-09

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

ENROLLING_BY_INVITATION

Total Enrollment

130 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-03-01

Study Completion Date

2030-04-01

Brief Summary

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The aim of this study is an explorative prospective observation of retinal ganglion cell degeneration and/or inner retina degeneration in Retinitis pigmentosa patients. The rate and patterns of progression will be correlated to the outer retina layers as well as clinical and genetic data of patients. Secondary goal is to determine potential parameters for optogenetic treatment eligibility.

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

Interventions

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imaging

OCT, OCTA, RNFL-OCT, fundus autofluorescence, fundus imaging, flaremeter, fundus and slit lamp examination

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* genetically diagnosed Retintis pigmentosa
* minimum age of 18 years (legal adult age in Germany)
* patient consent for study participation

Exclusion Criteria

* lack of capacity to consent in participation of study (unconsciousness, mental capacity, mental illness)
* reduced cooperation during imaging or examination
* age under 18 years
* presence of additional retinal diseases
* insufficient imaging quality due to hazy media (cornea, lense)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Medical Center Goettingen

OTHER

Sponsor Role lead

Responsible Party

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Emilie Macé

Professor Dr. Emilie Macé, Department of Ophthalmology, Center of Biostructural Imaging

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Emilie Macé, Professor

Role: PRINCIPAL_INVESTIGATOR

Else Kroener Fresenius Center for Optogenetic Therapies, University Medical Center Goettingen

Locations

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EKFZ Else Kroener Fresenius Center for Optogenetic Therapies, University Medical Center Goettingen

Göttingen, , Germany

Site Status

Countries

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Germany

Other Identifiers

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2025-03803

Identifier Type: -

Identifier Source: org_study_id

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