Retinitis PigmentosaNCT05853107
Pilot Study of AuTNA I
A study testing AuTNA I in people with Retinitis Pigmentosa, run by Eye & ENT Hospital of Fudan University at 1 site in China.
Trial summary
The objective of the study is to evaluate: 1. Safety of AuTNA I for subretinal implantation in patients with retinitis pigmentosa; 2. Efficacy of AuTNA I for subretinal implantation in patients with retinitis pigmentosa. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Retinitis Pigmentosa
- What is being tested?
- AuTNA I
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteChina
- Study dates
- 12 May 2023to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18-70 years of age.
- 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:
- poor night vision before vision loss;
- standard 5 ERG examination showing more severely damaged scotopic response than photopic, even non response
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- impaired peripheral visual field in perimetry (when the patient's vision permits).
- No or suspicious light perception in the eye for AuTNA I implantation.
- Intact inner retinal structure on OCT. No macular retinal or choroidal neovascularization.
- Voluntary to participate in the study and sign the informed consent.
Who cannot join
- Entities that might interfere with the functioning of AuTNA I, e.g. open ocular trauma, retinal detachment, glaucoma, severe uveitis, etc.
- Uncontrolled systemic diseases including hypertension (systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥100mmHg), diabetes (blood glucose ≥8.0mmol/L with medication);
- Allergic constitution.
- Entities that might prevent the observation of the fundus, e.g. corneal opacity, etc.
- Ocular disease not suitable for undertaking the implantation surgery, e.g. corneal ulcers, etc.
- Habits of rubbing the eyes.
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- 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).
- Pregnancy, lactating or planning to be pregnant within 6 months.
- History of epilepsy or serious psychiatric diseases.
- Other local or systemic diseases that may affect the vision.
- Participation in other clinical trials within 1 month before this study.
- Other conditions that the researcher found imporper to be included into this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Chunhui Jiang
Shanghai, Shanghai Municipality, 200030
Chunhui Jiang, +8621-64377134-2501, chhjiang70@163.com
About this study
Official title: Pilot Study of AuTNA I (Au Nanoparticle-decorated TiO2 Nanowire Arrays, Retinal Prothesis) -a Safety and Efficacy Evaluation.
The objective of the study is to evaluate:
- Safety of AuTNA I for subretinal implantation in patients with retinitis pigmentosa;
- Efficacy of AuTNA I for subretinal implantation in patients with retinitis pigmentosa.
Read the detailed description
In this study, AuTNA I (nanoparticle-decorated TiO2 Nanowire Arrays), which is designed to replace the damaged photoreceptors in RP patients, was implanted in one eye of the subjects. The change or improvement in the visual acuity of the subjects, as well as the potential side effects, was then fully evaluated.
- Conditions
- Retinitis Pigmentosa
- Being tested
- AuTNA I
- Medical subject headings
- Retinitis Pigmentosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AuTNA IDevice
AuTNA I means Au nanoparticle-decorated TiO2 Nanowire Arrays, a retinal prothesis designed for subretinal implantation.
| Study group | Role | What they receive |
|---|---|---|
| Implant AuTNA I | Experimental | This is a single arm study where the status and performance of the implanted eye prior to the surgery serves as the comparator. Receives: Device: AuTNA I |
What is being measured
The primary outcome is the main question the study is designed to answer.
FST
FST means Full-field Sensitivity Threshold. The thresholds of light with different wavelengths. The exam was performed at baseline and at various time points throughout the first year after the implantation.
Measured: Baseline and improvement of FST at 3 months.
BCVA
BCVA means Best-Corrected Visual Acuity, and is measured by Snellen Chart, EDTRS Chart and charts designed for people with low vision. It's performed at baseline and at various timepoints throughout the first year after the implantation.
Measured: Baseline and improvement of BCVA at 3 months.
Clinical electrophysiology of vision
Electrophysiological examinations of the visual pathway to evaluate the light responsiveness, including VEP, ERG and mfERG (Multifocal ERG). It's performed at baseline and at various timepoints throughout the first year after the implantation.
Measured: Baseline and improvement of electrophysiology at 3 months.
ElectroEncephaloGram
EEG(ElectroEncephaloGram) target frequency power amplitude and signal-to-noise ratio (SNR) would be used to analyse the visual stimulus steady-state evoked potential paradigms. It's performed at baseline and at various timepoints throughout the first year after the implantation.
Measured: Baseline and change of EEG at 3 months.
Functional Magnetic Resonance Imaging
Using fMRI (Functional Magnetic Resonance Imaging) to measure visual stimulus-induced brain activity caused by changes in blood flow. It's performed at baseline and at various timepoints throughout the first year after the implantation.
Measured: Baseline and change of fMRI at 3 months.
Secondary outcomes (3)
Visual field
The visual sensitivity of the implantation site of the fundus is measured with microfield perimetry. It's performed at baseline and at various timepoints throughout the first year after the implantation.
Measured: Recruitment (baseline) and 3 months, 6 months and 1 year after implantation.
Line task
To record the completion (completed/failed, time course if completed) of walking along a five-meter-long white strip on the black floor in a well-illuminated environment. It's performed at baseline and at various timepoints throughout the first year after the implantation.
Measured: Recruitment (baseline) and 3 months, 6 months and 1 year after implantation.
VisQoL
Vision-related quality of life is assessed with the VisQoL (Vision and Quality of Life) scale. It's performed at baseline and at various timepoints throughout the first year after the implantation.
Measured: Recruitment (baseline) and 3 months, 6 months and 1 year after implantation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2023
- Study start12 May 2023
- Primary completion28 Feb 2026 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinitis PigmentosaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eye & ENT Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Fudan University
- Responsible party
- Sponsor
- Investigators
- Chunhui Jiang, Study director, Eye & ENT Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05853107
- Sponsor's protocol ID
- AuTNA I
- Status last verified
- Sep 2025
- First submitted
- 15 Apr 2023
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of AuTNA I (Au Nanoparticle-decorated TiO2 Nanowire Arrays, Retinal Prothesis) -a Safety and Efficacy Evaluation.
- ClinicalTrials.gov ID
- NCT05853107
- Acronym / sponsor ID
- AuTNA I
- Conditions
- Retinitis Pigmentosa
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 7 participants (estimated)
- Lead sponsor
- Eye & ENT Hospital of Fudan UniversityUniversity, hospital or other
- Collaborators
- Fudan University
- Study start
- 12 May 2023 (actual)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 10 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the study is to evaluate:
- Safety of AuTNA I for subretinal implantation in patients with retinitis pigmentosa;
- Efficacy of AuTNA I for subretinal implantation in patients with retinitis pigmentosa.
Detailed description
In this study, AuTNA I (nanoparticle-decorated TiO2 Nanowire Arrays), which is designed to replace the damaged photoreceptors in RP patients, was implanted in one eye of the subjects. The change or improvement in the visual acuity of the subjects, as well as the potential side effects, was then fully evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Implant AuTNA I | Experimental | Device: AuTNA IThis is a single arm study where the status and performance of the implanted eye prior to the surgery serves as the comparator. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age: 18-70 years of age.
- 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.
- No or suspicious light perception in the eye for AuTNA I implantation.
- Intact inner retinal structure on OCT. No macular retinal or choroidal neovascularization.
Key exclusion criteria (12 listed)
- Entities that might interfere with the functioning of AuTNA I, e.g. open ocular trauma, retinal detachment, glaucoma, severe uveitis, etc.
- Uncontrolled systemic diseases including hypertension (systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥100mmHg), diabetes (blood glucose ≥8.0mmol/L with medication);
- Allergic constitution.
- Entities that might prevent the observation of the fundus, e.g. corneal opacity, etc.
- Ocular disease not suitable for undertaking the implantation surgery, e.g. corneal ulcers, etc.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AuTNA IAuTNA I means Au nanoparticle-decorated TiO2 Nanowire Arrays, a retinal prothesis designed for subretinal implantation. | Device | Implant AuTNA I |
Primary outcome
FST
Time frame: Baseline and improvement of FST at 3 months.
FST means Full-field Sensitivity Threshold. The thresholds of light with different wavelengths. The exam was performed at baseline and at various time points throughout the first year after the implantation.
BCVA
Time frame: Baseline and improvement of BCVA at 3 months.
BCVA means Best-Corrected Visual Acuity, and is measured by Snellen Chart, EDTRS Chart and charts designed for people with low vision. It's performed at baseline and at various timepoints throughout the first year after the implantation.
Clinical electrophysiology of vision
Time frame: Baseline and improvement of electrophysiology at 3 months.
Electrophysiological examinations of the visual pathway to evaluate the light responsiveness, including VEP, ERG and mfERG (Multifocal ERG). It's performed at baseline and at various timepoints throughout the first year after the implantation.
ElectroEncephaloGram
Time frame: Baseline and change of EEG at 3 months.
EEG(ElectroEncephaloGram) target frequency power amplitude and signal-to-noise ratio (SNR) would be used to analyse the visual stimulus steady-state evoked potential paradigms. It's performed at baseline and at various timepoints throughout the first year after the implantation.
Functional Magnetic Resonance Imaging
Time frame: Baseline and change of fMRI at 3 months.
Using fMRI (Functional Magnetic Resonance Imaging) to measure visual stimulus-induced brain activity caused by changes in blood flow. It's performed at baseline and at various timepoints throughout the first year after the implantation.
3 secondary outcomes
Visual field
Time frame: Recruitment (baseline) and 3 months, 6 months and 1 year after implantation.
Line task
Time frame: Recruitment (baseline) and 3 months, 6 months and 1 year after implantation.
VisQoL
Time frame: Recruitment (baseline) and 3 months, 6 months and 1 year after implantation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chunhui Jiang study director
Eye & ENT Hospital of Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AuTNA I in people with Retinitis Pigmentosa, run by Eye & ENT Hospital of Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chunhui Jiang (+8621-64377134-2501, chhjiang70@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FST (time frame: Baseline and improvement of FST at 3 months.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.