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EyeConic: Qualification for Cone-Optogenetics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05294978
Recruitment Status : Recruiting
First Posted : March 24, 2022
Last Update Posted : May 18, 2022
Sponsor:
Collaborator:
Institute of Molecular and Clinical Ophthalmology Basel, Switzerland
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Brief 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.

Condition or disease Intervention/treatment
Retinal Dystrophies Diagnostic Test: OCT

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.

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Qualification for Cone-Optogenetics (EyeConic)
Actual Study Start Date : July 1, 2021
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : December 2022


Group/Cohort Intervention/treatment
Patients
-Availability of macular optical coherence tomography (OCT)
Diagnostic Test: OCT
Macular optical coherence tomography (OCT)

Controls
-Availability of macular optical coherence tomography (OCT)
Diagnostic Test: OCT
Macular optical coherence tomography (OCT)




Primary Outcome Measures :
  1. OCT - Central retinal volume [ Time Frame: Baseline (about 10 minutes) ]
    Number of participants with preserved central retinal volume



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
  • Patients with diagnosis of generalized retinal dystrophy
  • Normal controls
Criteria

Inclusion Criteria (patients):

  • 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)

Inclusion Criteria (controls):

  • Normal ophthalmic findings
  • Availability of macular optical coherence tomography (OCT)

Exclusion Criteria (all):

  • Other eye diseases with a significant effect on vision or retinal structure
  • Extraocular disease affecting retinal structure such as neurodegenerative diseases

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05294978


Contacts
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Contact: Lucas Janeschitz-Kriegl, MD +41787494373 lucas.janeschitz@iob.ch
Contact: Daniela Hauenstein +41612658718 daniela.hauenstein@usb.ch

Locations
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United States, California
University of California San Francisco, Department of Ophthalmology Recruiting
San Francisco, California, United States, 94158
Principal Investigator: Jacque Duncan, MD         
United States, Florida
Bascom Palmer Eye Institute Recruiting
Miami, Florida, United States, 33136
Principal Investigator: Byron L Lam, MD         
Sub-Investigator: Potyra Rosa, MD         
United States, Pennsylvania
University of Pittsburgh, Department of Ophthalmology Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Principal Investigator: Jose A Sahel, MD         
Sub-Investigator: Boris Rosin, MD         
Sub-Investigator: Michelle Alabek, MD         
China
Beijing Institute of Ophthalmology Recruiting
Beijing, China
Principal Investigator: Jin Zi-Bing, MD         
Sub-Investigator: Shen Ren-Zuan, MD         
Germany
Universitätsklinikum Tübingen Augenklinik Recruiting
Tübingen, Germany
Principal Investigator: Katarina Stingl, MD         
Sub-Investigator: Melanie Kempf, MSc         
Hungary
Semmelweis University, Department of Ophthalmology Recruiting
Budapest, Hungary
Principal Investigator: Nagy Zoltan, MD         
Sub-Investigator: Viktoria Szabo, MD         
Italy
Oculista Ospedale Parma Recruiting
Parma, Italy
Contact: Stefano Gandolfi, MD         
Principal Investigator: Giacomo Calzetti, MD         
Switzerland
University Hospital Basel, Eye Clinic Recruiting
Basel, Switzerland, 4031
Contact: Hendrik PN Scholl, MD    +41612658651    hendrik.scholl@usb.ch   
Principal Investigator: Hendrik PN Scholl, MD         
Sub-Investigator: Bence György, MD         
Sub-Investigator: Lucas Janeschitz-Kriegl, MD         
United Kingdom
Moorfields Eye Hospital Recruiting
London, United Kingdom
Principal Investigator: Michel Michalides, MD         
Sub-Investigator: Michalis Georgiu, MD         
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Institute of Molecular and Clinical Ophthalmology Basel, Switzerland
Investigators
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Principal Investigator: Hendrik PN Scholl, MD University Hospital Basel/Institute of Molecular and Clinical Ophthalmology Basel, Switzerland
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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT05294978    
Other Study ID Numbers: IOB_EyeConic_2021
First Posted: March 24, 2022    Key Record Dates
Last Update Posted: May 18, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Basel, Switzerland:
Cone-Optogenetics
Rod-cone Dystrophy
Cone-rod Dystrophy
Generalized retinal dystrophies
Inherited retinal disease
Additional relevant MeSH terms:
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Retinal Dystrophies
Retinal Degeneration
Retinal Diseases
Eye Diseases