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Tiny nanowire implant aims to restore sight in rare eye disease

NCT ID NCT05853107

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This pilot study is testing a new retinal implant called AuTNA I in 7 people with retinitis pigmentosa, a genetic condition that causes progressive vision loss. The implant, a tiny array of nanowires placed under the retina, is designed to replace damaged light-sensing cells. Researchers will check safety and measure any vision improvements over one year using eye tests, brain scans, and electrical activity tests.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AuTNA I retinal prosthesis (nanoparticle-decorated titanium dioxide nanowire array device implanted under the retina)
What this could lead to
If successful, this could offer a new way to restore some vision in people with retinitis pigmentosa who have lost sight.
What could go wrong
This is a very early pilot study with only 7 people, so results may not apply widely. The implant is a new device, and risks like surgical complications or lack of vision improvement are possible.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 7 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2023

Expected to finish

Feb 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age: 18-70 years of age. 2. Clinically diagnosed as retinitis pigmentosa (one of the following two conditions): ① typical triadfundus manifestations: "osteoblastic" pigmentation of retina, arterial stenosis, and waxy atrophy of optic disc. ② typical fundus changes with both a and b, with or without c: 1. poor night vision before vision loss; 2. standard 5 ERG examination showing more severely damaged scotopic response than photopic, even non response 3. impaired peripheral visual field in perimetry (when the patient's vision permits). 3. No or suspicious light perception in the eye for AuTNA I implantation. 4. Intact inner retinal structure on OCT. No macular retinal or choroidal neovascularization. 5. Voluntary to participate in the study and sign the informed consent. Exclusion Criteria: 1. Entities that might interfere with the functioning of AuTNA I, e.g. open ocular trauma, retinal detachment, glaucoma, severe uveitis, etc. 2. Uncontrolled systemic diseases including hypertension (systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥100mmHg), diabetes (blood glucose ≥8.0mmol/L with medication); 3. Allergic constitution. 4. Entities that might prevent the observation of the fundus, e.g. corneal opacity, etc. 5. Ocular disease not suitable for undertaking the implantation surgery, e.g. corneal ulcers, etc. 6. Habits of rubbing the eyes. 7. Compromised liver function (ALT and AST 1.5 times over the normal limits), renal function (Cr 1.5 times over the normal limits), coagulation function (APTT 1.5 times over the normal limits). 8. Pregnancy, lactating or planning to be pregnant within 6 months. 9. History of epilepsy or serious psychiatric diseases. 10. Other local or systemic diseases that may affect the vision. 11. Participation in other clinical trials within 1 month before this study. 12. Other conditions that the researcher found imporper to be included into this study.

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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.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Chunhui Jiang

    RECRUITING

    Shanghai, Shanghai Municipality, 200030, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.