Clinical trial NCT05294978: EyeConic: Qualification for Cone-Optogenetics
Official title: Qualification for Cone-Optogenetics (EyeConic)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Retinal Dystrophies
Keywords: Cone-Optogenetics
Rod-cone Dystrophy
Cone-rod Dystrophy
Generalized retinal dystrophies
Inherited retinal disease
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Institute of Molecular and Clinical Ophthalmology Basel
First posted: 2022-03-24
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Patients with diagnosis of generalized retinal dystrophy
* Normal controls

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.

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.

Eligibility 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

Primary outcomes:
measure: OCT - Central retinal volume
timeFrame: Baseline (about 10 minutes)
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco, Department of Ophthalmology
state: California
city: Miami
country: United States
facility: Bascom Palmer Eye Institute
state: Florida
city: Pittsburgh
country: United States
facility: University of Pittsburgh, Department of Ophthalmology
state: Pennsylvania
city: Beijing
country: China
facility: Beijing Institute of Ophthalmology
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen Augenklinik
city: Budapest
country: Hungary
facility: Semmelweis University, Department of Ophthalmology
city: Parma
country: Italy
facility: Oculista Ospedale Parma
city: Basel
country: Switzerland
facility: University Hospital Basel, Eye Clinic
city: London
country: United Kingdom
facility: Moorfields Eye Hospital
Study officials:
affiliation: University Hospital Basel/Institute of Molecular and Clinical Ophthalmology Basel, Switzerland
name: Nicolas Feltgen, MD
role: PRINCIPAL_INVESTIGATOR
References: