Retinitis PigmentosaNCT07056738
Prospective Exploratory Cohort Study on Ganglion Cell Degeneration in Retinitis Pigmentosa Patients
An observational study of Retinitis Pigmentosa, run by University Medical Center Goettingen at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retinitis Pigmentosa
- What is being tested?
- imaging
- How many people
- 130 participants
- Where
- 1 siteGermany
- Study dates
- 1 Mar 2025to 1 Apr 2030
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Existing Retinitis pigmentosa patients at the University clinic Göttingen. Patients with Retinitis pigmentosa within Pro Retina self-help groups.
Who may be able to join
- genetically diagnosed Retintis pigmentosa
- minimum age of 18 years (legal adult age in Germany)
- patient consent for study participation
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site
EKFZ Else Kroener Fresenius Center for Optogenetic Therapies, University Medical Center Goettingen
Göttingen, 37075
About this study
Official title: Longitudinal Characterization of Inner Retina Health in Low Vision Retinitis Pigmentosa Patients to Optimize Retinal Ganglion Cell-based Optogenetic Vision Restoration Therapy
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
- Being tested
- imaging
- Keywords
- Retinitis pigmentosa, Ganglion cells, Inner retina, Optogenetics
- Medical subject headings
- Retinitis Pigmentosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
imagingDiagnostic test
OCT, OCTA, RNFL-OCT, fundus autofluorescence, fundus imaging, flaremeter, fundus and slit lamp examination
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 6 months intervals, overall time span 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2025
- Study start1 Mar 2025
- Primary completion1 Mar 2030 (estimated)
- Study completion1 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinitis PigmentosaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- University Medical Center Goettingen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emilie Macé, University Medical Center Goettingen
- Investigators
- Emilie Macé, Professor, Principal investigator, Else Kroener Fresenius Center for Optogenetic Therapies, University Medical Center Goettingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07056738
- Sponsor's protocol ID
- 2025-03803
- Other IDs
- 2025
- Status last verified
- Jun 2025
- First submitted
- 29 Jun 2025
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Characterization of Inner Retina Health in Low Vision Retinitis Pigmentosa Patients to Optimize Retinal Ganglion Cell-based Optogenetic Vision Restoration Therapy
- ClinicalTrials.gov ID
- NCT07056738
- Acronym / sponsor ID
- 2025-03803
- Conditions
- Retinitis Pigmentosa
- Keywords
- Retinitis pigmentosa, Ganglion cells, Inner retina, Optogenetics
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- University Medical Center GoettingenUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 1 Mar 2030 (estimated)
- Study completion
- 1 Apr 2030 (estimated)
- First posted
- 9 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Existing Retinitis pigmentosa patients at the University clinic Göttingen. Patients with Retinitis pigmentosa within Pro Retina self-help groups.
Key inclusion criteria (3 listed)
- genetically diagnosed Retintis pigmentosa
- minimum age of 18 years (legal adult age in Germany)
- patient consent for study participation
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| imagingOCT, OCTA, RNFL-OCT, fundus autofluorescence, fundus imaging, flaremeter, fundus and slit lamp examination | Diagnostic test | – |
Primary outcome
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.
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.
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)
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)
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
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
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
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
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
- Individual participant dataSharing planned: No
Related trials for Retinitis Pigmentosa
RecruitingObservational study
Rod and Cone Mediated Function in Retinal Disease
Retinal Degeneration, Retinitis Pigmentosa
RecruitingObservational study
Cell Collection to Study Eye Diseases
Retinal Disease, AMD
Recruiting
Brain Stimulation Effects on Orientation and Mobility Skills in Adults With Vision Impairment
Retinitis Pigmentosa (RP), Rod Cone Dystrophy
RecruitingObservational study
Universal Rare Gene Study: A Registry and Natural History Study of Retinal Dystrophies Associated With Rare Disease-Causing Genetic Variants
Inherited Retinal Degeneration, Retinitis Pigmentosa
Active, not recruitingObservational study
Rate of Progression in EYS Related Retinal Degeneration
Retinitis Pigmentosa, Eye Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emilie Macé, Professor principal investigator
Else Kroener Fresenius Center for Optogenetic Therapies, University Medical Center Goettingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Retinitis Pigmentosa, run by University Medical Center Goettingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 9 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thickness of ganglion cell inner plexiforme layer (GCIPL) in OCT imaging (time frame: 6 months intervals, overall time span 5 years). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2025.