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

NCT07056738 | Enrolling By Invitation

• 1 other identifier: 2025-03803
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Retinitis Pigmentosa

Keywords

Retinitis pigmentosa; Ganglion cells; Inner retina; Optogenetics

Outcome Measures

Primary Outcomes (9)

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

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

  6 months intervals, overall time span 5 years

• Thickness of RNFL thickness in OCT imaging

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

  6 months intervals, overall time span 5 years

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

  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)

  6 months intervals, overall time span 5 years

• Thickness and morphology of inner and outer retinal layers measured with OCT, fundus photography, FAF

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

  6-12 months intervals, overall time span 5 years

• Changes in functional parameters such as BCVA

  Changes in functional parameters such as best corrected visual acuity

  6 months intervals, overall time span 5 years

• Correlations of outcome 1-5 with clinical data of patients

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

  6 months intervals, overall time span 5 years

• Correlations of outcome 1-5 with genetic data of patients

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

  6 months intervals, overall time span 5 years

• Correlation of outcome 1-5 with inflammatory markers

  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

  6 months intervals, overall time span 5 years

• Correlation of inner and outer retina parameters over time

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

  6 months intervals, overall time span 5 years

Interventions

imaging DIAGNOSTIC_TEST

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Existing Retinitis pigmentosa patients at the University clinic Göttingen. Patients with Retinitis pigmentosa within Pro Retina self-help groups.

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Medical Center Goettingen: lead

Study Sites (1)

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

Göttingen, 37075, Germany

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood serum samples to identify levels of inflammatory markers

MeSH Terms

Conditions

Retinitis Pigmentosa

Interventions

Diagnostic Imaging

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Emilie Macé, Professor

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Dr. Emilie Macé, Department of Ophthalmology, Center of Biostructural Imaging

Study Record Dates

• First Submitted: June 29, 2025
• First Posted: July 9, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): March 1, 2030
• Study Completion (Estimated): April 1, 2030
• Last Updated: July 9, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)