Pilot Study of AuTNA I

Not Applicable

Recruiting

• Conditions: Retinitis Pigmentosa
• Interventions: Device: AuTNA I

• Registration Number: NCT05853107
• Lead Sponsor: Eye & ENT Hospital of Fudan University

Brief 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.

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 Timeline

• Study First Submitted: 2023-04-15
• Status Verified: 2023-05
• Study First Submitted QC: 2023-05-02
• Last Update Submitted: 2023-05-02
• Study First Posted: 2023-05-10
• Last Update Posted: 2023-05-10
• Study Start: 2023-05-12
• Primary Completion: 2026-02-28
• Study Completion: 2026-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

1. Age: 18-60 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Implant AuTNA I	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.

Primary Outcome Measures

Name	Time	Method
FST	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	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	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	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	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.

Secondary Outcome Measures

Name	Time	Method
Visual field	Recruitment (baseline) and 3 months, 6 months and 1 year after implantation.	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.
Line task	Recruitment (baseline) and 3 months, 6 months and 1 year after implantation.	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.
VisQoL	Recruitment (baseline) and 3 months, 6 months and 1 year after implantation.	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.

Trial Locations

Locations (1)

Chunhui Jiang; 🇨🇳 Shanghai, Shanghai, China