Pilot Study of AuTNA I

NCT05853107 | Recruiting

• 1 other identifier: AuTNA I
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the study is to evaluate:

1. 1.Safety of AuTNA I for subretinal implantation in patients with retinitis pigmentosa;
2. 2.Efficacy of AuTNA I for subretinal implantation in patients with retinitis pigmentosa.

Conditions

Retinitis Pigmentosa

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  Baseline and change of fMRI at 3 months.

Secondary Outcomes (3)

• Visual field

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

• Line task

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

• VisQoL

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

Study Arms (1)

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.

Device: AuTNA I

Interventions

AuTNA I DEVICE

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

Implant AuTNA I

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Eye & ENT Hospital of Fudan University: lead
• Fudan University: collaborator

Study Sites (1)

Chunhui Jiang

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

MeSH Terms

Conditions

Retinitis Pigmentosa

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Retinal Dystrophies; Retinal Degeneration; Retinal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Chunhui Jiang

  Eye and ENT Hospital of Fudan University

  STUDY DIRECTOR

Central Study Contacts

Chunhui Jiang

CONTACT

+8621-64377134-2501; chhjiang70@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2023
• First Posted: May 10, 2023
• Study Start: May 12, 2023
• Primary Completion: February 28, 2026
• Study Completion: February 28, 2026
• Last Updated: September 19, 2025

Record last verified: 2025-09

Locations

CN (1)