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RecruitingNCT05853107Updated Sep 19, 2025

Pilot Study of AuTNA I

An interventional study of AuTNA I in Retinitis Pigmentosa, sponsored by Eye & ENT Hospital of Fudan University. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-09-19.

Sponsored by Eye & ENT Hospital of Fudan University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Feb 2026, 7 months ago, but the record still lists the study as recruiting.
  • Started May 2023; still recruiting 3 years 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
7
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Retinitis Pigmentosa

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03

In context

Retinitis Pigmentosa

268 studies on the registry are indexed under Retinitis Pigmentosa; 71 are open to participants now.

This study's planned enrollment of 7 is below the median of 27 across 173 interventional studies indexed under Retinitis Pigmentosa.

Browse Retinitis Pigmentosa studies →

Lead sponsor

Eye & ENT Hospital of Fudan University is the lead sponsor of 121 studies on the registry; 67 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
7 participants (estimated)

Study arms

  • Experimental
    Implant AuTNA I

    This is a single arm study where the status and performance of the implanted eye prior to the surgery serves as the comparator.

    Device: AuTNA I

Interventions

  • DeviceAuTNA I

    AuTNA I means Au nanoparticle-decorated TiO2 Nanowire Arrays, a retinal prothesis designed for subretinal implantation.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline and improvement of FST at 3 months.

  2. 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.

    Time frame: Baseline and improvement of BCVA at 3 months.

  3. 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.

    Time frame: Baseline and improvement of electrophysiology at 3 months.

  4. 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.

    Time frame: Baseline and change of EEG at 3 months.

  5. 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.

    Time frame: Baseline and change of fMRI at 3 months.

Secondary outcomes

  1. 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.

    Time frame: Recruitment (baseline) and 3 months, 6 months and 1 year after implantation.

  2. 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.

    Time frame: Recruitment (baseline) and 3 months, 6 months and 1 year after implantation.

  3. 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.

    Time frame: Recruitment (baseline) and 3 months, 6 months and 1 year after implantation.

07

Study locations

1 of 1 sites recruiting
  • Chunhui Jiang
    Shanghai, Shanghai Municipality 200030, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05853107
Lead sponsor
Eye & ENT Hospital of Fudan University
Collaborators
Fudan University
Responsible party
Sponsor
First posted
May 10, 2023
Start date
May 12, 2023
Primary completion
Feb 28, 2026 (estimated)
Completion
Feb 28, 2026 (estimated)
Last update
Sep 19, 2025

Study contacts

Chunhui Jiang
Contact
chhjiang70@163.com
+8621-64377134-2501
Chunhui Jiang
study director · Eye and ENT Hospital of Fudan University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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