Qualification for Cone-Optogenetics

Retinal Dystrophies Clinical Trial

Official title:

Qualification for Cone-Optogenetics (EyeConic)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05218928
• Other study ID #: IOB-EyeConic-2021
• Status: Recruiting
• Start date: July 1, 2021
• Est. completion date: December 2022

Study information

• Verified date: January 2022
• Source: University Hospital, Basel, Switzerland
• Contact: Lucas Janeschitz-Kriegl, MD
• Phone: +41787494373
• Email: lucas.janeschitz[@]iob.ch
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2022
• Est. primary completion date: April 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Retinal Dystrophies

Intervention

Diagnostic Test:
• OCT
Macular optical coherence tomography (OCT)

Locations

Country	Name	City	State
China	Beijing Institute of Ophthalmology	Beijing
Germany	Universitätsklinikum Tübingen Augenklinik	Tübingen
Hungary	Semmelweis University, Department of Ophthalmology	Budapest
Italy	Oculista Ospedale Parma	Parma
Switzerland	University Hospital Basel, Eye Clinic	Basel
United Kingdom	Moorfields Eye Hospital	London
United States	Bascom Palmer Eye Institute	Miami	Florida
United States	University of Pittsburgh, Department of Ophthalmology	Pittsburgh	Pennsylvania
United States	University of California San Francisco, Department of Ophthalmology	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	Institute of Molecular and Clinical Ophthalmology Basel, Switzerland

Countries where clinical trial is conducted

United States,  China,  Germany,  Hungary,  Italy,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Foveolar Volume (µm)	Volume of the foveolar hypercylinder centered around foveal center (µm)	Baseline (about 10 minutes)