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Enrolling by invitation NCT07056738

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

— Observational Retinitis Pigmentosa

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: imaging.
Who it may be relevant to
Registry conditions: Retinitis Pigmentosa. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Longitudinal Characterization of Inner Retina Health in Low Vision Retinitis Pigmentosa Patients to Optimize Retinal Ganglion Cell-based Optogenetic Vision Restoration Therapy

Overview

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.

Interventions

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

Primary outcome measures

  • Thickness of ganglion cell inner plexiforme layer (GCIPL) in OCT imaging [Time frame: 6 months intervals, overall time span 5 years]
  • Thickness of RNFL thickness in OCT imaging [Time frame: 6 months intervals, overall time span 5 years]
  • PD, VD, ICA of the SRP and DRP with OCTA imaging [Time frame: 6 months intervals, overall time span 5 years]
  • Thickness and morphology of inner and outer retinal layers measured with OCT, fundus photography, FAF [Time frame: 6-12 months intervals, overall time span 5 years]
  • Changes in functional parameters such as BCVA [Time frame: 6 months intervals, overall time span 5 years]
  • Correlations of outcome 1-5 with clinical data of patients [Time frame: 6 months intervals, overall time span 5 years]
  • Correlations of outcome 1-5 with genetic data of patients [Time frame: 6 months intervals, overall time span 5 years]
  • Correlation of outcome 1-5 with inflammatory markers [Time frame: 6 months intervals, overall time span 5 years]
  • Correlation of inner and outer retina parameters over time [Time frame: 6 months intervals, overall time span 5 years]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Germany · 1 center
  • EKFZ Else Kroener Fresenius Center for Optogenetic Therapies, University Medical Center Go — Göttingen

Identifiers

NCT: NCT07056738 · 2025-03803

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗