Glasses that 'Talk' to Gene-Edited eyes: a new hope for blindness?
NCT ID NCT03326336
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage trial tests a combination treatment for retinitis pigmentosa, a genetic disease that causes blindness. Ten adults receive a single injection of GS030 gene therapy into one eye, then use special glasses that send light signals to the treated retina. The main goal is to check safety, but researchers also measure any changes in vision. The study is still ongoing and not yet recruiting.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- GS030 gene therapy (injected into the eye) plus special glasses that stimulate the treated retina with light
- What this could lead to
- If it works, this could restore some vision in people with retinitis pigmentosa who have lost most sight.
- What could go wrong
- This is a very early, small trial (10 people) focused on safety, not proof of effectiveness. The gene therapy and glasses are experimental, and vision improvement is not guaranteed.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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10 people
The number who actually took part.
- Started
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Sep 2018
- Expected to finish
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Oct 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion criteria: * Age ≥18 years to ≤75 years at the time of ICF signature. * Diagnosis of non-syndromic RP defined as: * Clinical diagnosis of non-syndromic RP based on history, mid-peripheral visual dysfunction, and fundoscopic appearance. * Diagnosis of non-syndromic RP is confirmed on full-field ERG * Visual acuity: * Visual acuity in the dose-escalation cohorts of no better LP. * Visual acuity in the extension cohort of no better than CF pending review of dose-escalation cohort data by the DSMB. * Relatively preserved ganglion cell layer volume and retinal nerve fiber layer thickness, as measured with spectral domain optical coherence tomography (SD-OCT). * Interpupillary distance of ≥51 mm and ≤72 mm. * Refractive error of the study eye between -6 diopters and +6 diopters. Exclusion criteria * Prior receipt of any gene therapy. * Subjects who have undergone significant ocular surgery (per investigator determination) within 3 months prior to Visit 1. * Presence of narrow iridocorneal angles contraindicating pupillary dilation. * Presence of disorders of the ocular media which interfere with visual acuity and other ocular assessments, including SD-OCT, during the study period. * Presence of any systemic or ocular diseases, or pathologies, other than non-syndromic RP, or their associated therapies, that can cause or have the potential to cause vision loss. * Prior vitrectomy or vitreomacular surgery. * Presence of vitreo-macular adhesion or traction, epiretinal membrane, macular pucker and macular hole, evident by ophthalmoscopy and/or by SD-OCT examinations and assessed by the investigator to significantly affect central vision. * Current evidence of retinal detachment assessed by the investigator to significantly affect central vision. * Active ocular inflammation or recurrent history of idiopathic or autoimmune associated uveitis. * Presence of an Active Implantable Medical Device. * Subjects who have undergone thermal laser procedure to the retina within 3 months of trial entry, or any prior thermal laser procedure to the macular region.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Centre Hospitalier National d'Ophtalmologie (CHNP) des Quinze-Vingts
Paris, 75012, France
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Moorfields Eye Hospital NHS Foundation Trust, 162 City Road
London, United Kingdom
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UPMC Eye Center
Pittsburgh, Pennsylvania, 15213, United States