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Enrolling by Invitation

NCT Number: NCT07056738

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

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.

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Key information

Conditions

Retinitis Pigmentosa Congenital, Hereditary, and Neonatal Diseases and Abnormalities Eye Diseases Eye Diseases, Hereditary Genetic Diseases, Inborn Retinal Degeneration Retinal Diseases Retinal Dystrophies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Göttingen, 37075, Germany

Who can participate

Healthy volunteers accepted: No

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

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)

Treatment and study plan

Imaging

Diagnostic Test

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

Primary outcomes

  1. Thickness of ganglion cell inner plexiforme layer (GCIPL) in OCT imaging

    Time frame: 6 months intervals, overall time span 5 years

    Measuring the thickness of the ganglion cell inner plexiforme layer (GCIPL) in macula optical coherence tomography (OCT) imaging of the retina.

  2. Thickness of RNFL thickness in OCT imaging

    Time frame: 6 months intervals, overall time span 5 years

    Measuring the thickness of the retinal nerve fiber layer (RNFL) in macular and optic nerve optical coherence tomography (OCT) imaging of the retina.

  3. PD, VD, ICA of the SRP and DRP with OCTA imaging

    Time frame: 6 months intervals, overall time span 5 years

    Perfusion density (PD), vessel density (VD), intercapillary area size (ICA) of superficial retinal plexus (SRP) and deep retinal plexus (DRP) in OCTA imaging (optical coherence tomography angiography)

  4. 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

    Thickness and morphology of inner and outer retinal layers measured with optical coherence tomography (OCT), fundus photography, fundus autofluorescence (FAF)

  5. Changes in functional parameters such as BCVA

    Time frame: 6 months intervals, overall time span 5 years

    Changes in functional parameters such as best corrected visual acuity

  6. Correlations of outcome 1-5 with clinical data of patients

    Time frame: 6 months intervals, overall time span 5 years

    Find correlations of imaging outcomes with the clinical data of patients, such as sex, age, age of onset of disease

  7. Correlations of outcome 1-5 with genetic data of patients

    Time frame: 6 months intervals, overall time span 5 years

    Find correlations of imaging outcomes with the Retinitis pigmentosa mutation and inheritance pattern of patients

  8. Correlation of outcome 1-5 with inflammatory markers

    Time frame: 6 months intervals, overall time span 5 years

    Correlation of imaging outcomes and disease progression with inflammatory markers collected with serum blood samples and flaremeter as well as slit lamp and fundus examination findings

  9. Correlation of inner and outer retina parameters over time

    Time frame: 6 months intervals, overall time span 5 years

    Correlation of changes in inner retina and outer retina of collected imaging data over time.

Sponsors and collaborators

Lead sponsor

University Medical Center Goettingen

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Jul 9, 2025
Registry last updated
Jul 9, 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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