Pilot Study of AuTNA I

Retinitis Pigmentosa Clinical Trial

Official title:

Pilot Study of AuTNA I (Au Nanoparticle-decorated TiO2 Nanowire Arrays, Retinal Prothesis) -a Safety and Efficacy Evaluation.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05853107
• Other study ID #: AuTNA I
• Status: Recruiting
• Phase: N/A
• Start date: May 12, 2023
• Est. completion date: February 28, 2026

Study information

• Verified date: May 2023
• Source: Eye & ENT Hospital of Fudan University
• Contact: Chunhui Jiang
• Phone: +8621-64377134-2501
• Email: chhjiang70[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 7
• Est. completion date: February 28, 2026
• Est. primary completion date: February 28, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Age: 18-60 years of age.

2. Clinically diagnosed as retinitis pigmentosa (one of the following two conditions):

? typical triadfundus manifestations: "osteoblastic" pigmentation of retina, arterial stenosis, and waxy atrophy of optic disc.

? 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.

Related Conditions & MeSH terms

• Retinitis
• Retinitis Pigmentosa

Intervention

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

Locations

Country	Name	City	State
China	Chunhui Jiang	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Eye & ENT Hospital of Fudan University	Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Secondary	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.	Recruitment (baseline) and 3 months, 6 months and 1 year after implantation.
Secondary	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.	Recruitment (baseline) and 3 months, 6 months and 1 year after implantation.
Secondary	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.	Recruitment (baseline) and 3 months, 6 months and 1 year after implantation.