NCT05294978

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.

Trial Health

83
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
7mo left

Started Jul 2021

Longer than P75 for all trials

Geographic Reach
7 countries

9 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress90%
Jul 2021Dec 2026

Study Start

First participant enrolled

July 1, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 16, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 24, 2022

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

July 31, 2025

Status Verified

July 1, 2025

Enrollment Period

5.4 years

First QC Date

February 16, 2022

Last Update Submit

July 28, 2025

Conditions

Keywords

Cone-OptogeneticsRod-cone DystrophyCone-rod DystrophyGeneralized retinal dystrophiesInherited retinal disease

Outcome Measures

Primary Outcomes (1)

  • OCT - Central retinal volume

    Number of participants with preserved central retinal volume

    Baseline (about 10 minutes)

Study Arms (2)

Patients

-Availability of macular optical coherence tomography (OCT)

Diagnostic Test: Optical coherence tomography (OCT)

Controls

-Availability of macular optical coherence tomography (OCT)

Diagnostic Test: Optical coherence tomography (OCT)

Interventions

Data of macular optical coherence tomography (OCT)

ControlsPatients

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

* Patients with diagnosis of generalized retinal dystrophy * Normal controls

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

University of California San Francisco, Department of Ophthalmology

San Francisco, California, 94158, United States

RECRUITING

Bascom Palmer Eye Institute

Miami, Florida, 33136, United States

RECRUITING

University of Pittsburgh, Department of Ophthalmology

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

Beijing Institute of Ophthalmology

Beijing, China

RECRUITING

Universitätsklinikum Tübingen Augenklinik

Tübingen, Germany

RECRUITING

Semmelweis University, Department of Ophthalmology

Budapest, Hungary

RECRUITING

Oculista Ospedale Parma

Parma, Italy

RECRUITING

University Hospital Basel, Eye Clinic

Basel, 4031, Switzerland

RECRUITING

Moorfields Eye Hospital

London, United Kingdom

RECRUITING

MeSH Terms

Conditions

Retinal DystrophiesCone-Rod Dystrophies

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye DiseasesEye Diseases, HereditaryGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Tomography, OpticalOptical ImagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomographyInvestigative Techniques

Study Officials

  • Nicolas Feltgen, MD

    University Hospital Basel/Institute of Molecular and Clinical Ophthalmology Basel, Switzerland

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lucas Janeschitz-Kriegl, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2022

First Posted

March 24, 2022

Study Start

July 1, 2021

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

July 31, 2025

Record last verified: 2025-07

Locations