Retinal DystrophiesNCT05294978
EyeConic: Qualification for Cone-Optogenetics
An observational study of Retinal Dystrophies, run by Institute of Molecular and Clinical Ophthalmology Basel at 9 sites in 7 countries.
Trial summary
This study aims to prepare for the first-in-human clinical trial of cone optogenetics vision restoration. As a first step, this worldwide multicenter ocular imaging study (EyeConic Study) is performed to identify eligible patients. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Retinal Dystrophies
- What is being tested?
- Optical coherence tomography (OCT)
- How many people
- 1,000 participants
- Where
- 9 sitesin 7 countries
- Study dates
- 1 Jul 2021to Dec 2026
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: * Patients with diagnosis of generalized retinal dystrophy * Normal controls
Who may be able to join
- Diagnosis of generalized IRD
- Low vision as defined as visual acuity worse or equal to 0.05 (or 20/400) in the study eye
- Availability of macular optical coherence tomography (OCT)
- Normal ophthalmic findings
- Availability of macular optical coherence tomography (OCT)
Who cannot join
- Other eye diseases with a significant effect on vision or retinal structure
- Extraocular disease affecting retinal structure such as neurodegenerative diseases
Trial locations and contacts
9 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
9 sites in 7 countries
United States3 sites, 3 recruiting
- Recruiting
Bascom Palmer Eye Institute
Miami, Florida, 33136
Byron L Lam, MD
Potyra Rosa, MD
- Recruiting
University of Pittsburgh, Department of Ophthalmology
Pittsburgh, Pennsylvania, 15213
Jose A Sahel, MD
Boris Rosin, MD
- Recruiting
University of California San Francisco, Department of Ophthalmology
San Francisco, California, 94158
Jacque Duncan, MD
China1 site, 1 recruiting
- Recruiting
Beijing Institute of Ophthalmology
Beijing
Jin Zi-Bing, MD
Shen Ren-Zuan, MD
Germany1 site, 1 recruiting
- Recruiting
Universitätsklinikum Tübingen Augenklinik
Tübingen
Katarina Stingl, MD
Melanie Kempf, MSc
Hungary1 site, 1 recruiting
- Recruiting
Semmelweis University, Department of Ophthalmology
Budapest
Nagy Zoltan, MD
Viktoria Szabo, MD
Italy1 site, 1 recruiting
- Recruiting
Oculista Ospedale Parma
Parma
Stefano Gandolfi, MD
Giacomo Calzetti, MD
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Basel, Eye Clinic
Basel, 4031
Nicolas Feltgen, MD, +41612659292, nicolas.feltgen@usb.ch
Nicolas Feltgen, MD
United Kingdom1 site, 1 recruiting
- Recruiting
Moorfields Eye Hospital
London
Michel Michalides, MD
Michalis Georgiu, MD
About this study
Official title: Qualification for Cone-Optogenetics (EyeConic)
This study aims to prepare for the first-in-human clinical trial of cone optogenetics vision restoration. As a first step, this worldwide multicenter ocular imaging study (EyeConic Study) is performed to identify eligible patients.
Read the detailed description
In a subset of patients with inherited retinal dystrophies (IRDs), cones lose their light-sensitive outer segments but remain alive in a dormant stage. This creates an opportunity to resensitize them through targeted optogenetic tools. However, the true proportion of low vision patients harboring dormant, non-functional cones, is currently unknown. The worldwide multicenter retrospective study (EyeConic) aims to estimate the proportion of low vision patients with remaining cone cell bodies for the first time.
- Conditions
- Retinal Dystrophies
- Being tested
- Optical coherence tomography (OCT)
- Keywords
- Cone-Optogenetics, Rod-cone Dystrophy, Cone-rod Dystrophy, Generalized retinal dystrophies, Inherited retinal disease
- Medical subject headings
- Retinal Dystrophies, Cone-Rod Dystrophies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical coherence tomography (OCT)Diagnostic test
Data of macular optical coherence tomography (OCT)
| Study group | Role | What they receive |
|---|---|---|
| Patients | -Availability of macular optical coherence tomography (OCT) Receives: Diagnostic Test: Optical coherence tomography (OCT) | |
| Controls | -Availability of macular optical coherence tomography (OCT) Receives: Diagnostic Test: Optical coherence tomography (OCT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
OCT - Central retinal volume
Number of participants with preserved central retinal volume
Measured: Baseline (about 10 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2022
- Study start1 Jul 2021
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal DystrophiesStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Molecular and Clinical Ophthalmology Basel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas Feltgen, MD, Principal investigator, University Hospital Basel/Institute of Molecular and Clinical Ophthalmology Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05294978
- Sponsor's protocol ID
- IOB_EyeConic_2021
- Status last verified
- Jul 2025
- First submitted
- 16 Feb 2022
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Qualification for Cone-Optogenetics (EyeConic)
- ClinicalTrials.gov ID
- NCT05294978
- Acronym / sponsor ID
- IOB_EyeConic_2021
- Conditions
- Retinal Dystrophies
- Keywords
- Cone-Optogenetics, Rod-cone Dystrophy, Cone-rod Dystrophy, Generalized retinal dystrophies, Inherited retinal disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Institute of Molecular and Clinical Ophthalmology BaselUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 24 Mar 2022 (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.
This study aims to prepare for the first-in-human clinical trial of cone optogenetics vision restoration. As a first step, this worldwide multicenter ocular imaging study (EyeConic Study) is performed to identify eligible patients.
Detailed description
In a subset of patients with inherited retinal dystrophies (IRDs), cones lose their light-sensitive outer segments but remain alive in a dormant stage. This creates an opportunity to resensitize them through targeted optogenetic tools. However, the true proportion of low vision patients harboring dormant, non-functional cones, is currently unknown. The worldwide multicenter retrospective study (EyeConic) aims to estimate the proportion of low vision patients with remaining cone cell bodies for the first time.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Diagnostic Test: Optical coherence tomography (OCT)-Availability of macular optical coherence tomography (OCT) |
| Controls | – | Diagnostic Test: Optical coherence tomography (OCT)-Availability of macular optical coherence tomography (OCT) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- * Patients with diagnosis of generalized retinal dystrophy * Normal controls
Key inclusion criteria (5 listed)
- Diagnosis of generalized IRD
- Low vision as defined as visual acuity worse or equal to 0.05 (or 20/400) in the study eye
- Availability of macular optical coherence tomography (OCT)
- Normal ophthalmic findings
- Availability of macular optical coherence tomography (OCT)
Key exclusion criteria (2 listed)
- Other eye diseases with a significant effect on vision or retinal structure
- Extraocular disease affecting retinal structure such as neurodegenerative diseases
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 |
|---|---|---|
| Optical coherence tomography (OCT)Data of macular optical coherence tomography (OCT) | Diagnostic test | Controls, Patients |
Primary outcome
OCT - Central retinal volume
Time frame: Baseline (about 10 minutes)
Number of participants with preserved central retinal volume
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 31 Jul 2025.
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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.
Nicolas Feltgen, MD principal investigator
University Hospital Basel/Institute of Molecular and Clinical Ophthalmology Basel, Switzerland
9 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Retinal Dystrophies, run by Institute of Molecular and Clinical Ophthalmology Basel at 9 sites in 7 countries.
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 5 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 31 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 9 sites in United States, China, Germany, Hungary, Italy and 2 more countries. 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?
Contact Lucas Janeschitz-Kriegl, MD (+41787494373, lucas.janeschitz@iob.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OCT - Central retinal volume (time frame: Baseline (about 10 minutes)). 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 31 Jul 2025.