EyeConic: Qualification for Cone-Optogenetics

December 6, 2023 updated by: University Hospital, Basel, Switzerland

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Beijing Institute of Ophthalmology
        • Principal Investigator:
          • Jin Zi-Bing, MD
        • Sub-Investigator:
          • Shen Ren-Zuan, MD
  • Germany
      • Tübingen, Germany
        • Recruiting
        • Universitätsklinikum Tübingen Augenklinik
        • Principal Investigator:
          • Katarina Stingl, MD
        • Sub-Investigator:
          • Melanie Kempf, MSc
  • Hungary
      • Budapest, Hungary
        • Recruiting
        • Semmelweis University, Department of Ophthalmology
        • Principal Investigator:
          • Nagy Zoltan, MD
        • Sub-Investigator:
          • Viktoria Szabo, MD
  • Italy
      • Parma, Italy
        • Recruiting
        • Oculista Ospedale Parma
        • Contact:
          • Stefano Gandolfi, MD
        • Principal Investigator:
          • Giacomo Calzetti, MD
  • Switzerland
      • Basel, Switzerland, 4031
        • Recruiting
        • University Hospital Basel, Eye Clinic
        • Contact:
        • Principal Investigator:
          • Hendrik PN Scholl, MD
        • Sub-Investigator:
          • Bence György, MD
        • Sub-Investigator:
          • Lucas Janeschitz-Kriegl, MD
  • United Kingdom
      • London, United Kingdom
        • Recruiting
        • Moorfields Eye Hospital
        • Principal Investigator:
          • Michel Michalides, MD
        • Sub-Investigator:
          • Michalis Georgiu, MD
  • United States
    • California
      • San Francisco, California, United States, 94158
        • Recruiting
        • University of California San Francisco, Department of Ophthalmology
        • Principal Investigator:
          • Jacque Duncan, MD
    • Florida
      • Miami, Florida, United States, 33136
        • Recruiting
        • Bascom Palmer Eye Institute
        • Principal Investigator:
          • Byron L Lam, MD
        • Sub-Investigator:
          • Potyra Rosa, MD
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Recruiting
        • University of Pittsburgh, Department of Ophthalmology
        • Principal Investigator:
          • Jose A Sahel, MD
        • Sub-Investigator:
          • Boris Rosin, MD
        • Sub-Investigator:
          • Michelle Alabek, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

  • Patients with diagnosis of generalized retinal dystrophy
  • Normal controls

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OCT - Central retinal volume
Time Frame: Baseline (about 10 minutes)
Number of participants with preserved central retinal volume
Baseline (about 10 minutes)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Collaborators

Institute of Molecular and Clinical Ophthalmology Basel

Investigators

  • Principal Investigator: Hendrik PN Scholl, MD, University Hospital Basel/Institute of Molecular and Clinical Ophthalmology Basel, Switzerland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2021

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

February 16, 2022

First Submitted That Met QC Criteria

March 14, 2022

First Posted (Actual)

March 24, 2022

Study Record Updates

Last Update Posted (Estimated)

December 7, 2023

Last Update Submitted That Met QC Criteria

December 6, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IOB_EyeConic_2021

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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