Pilot Study of AuTNA I

NCT ID: NCT05853107

Last Updated: 2025-09-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-12
• Study Completion Date: 2026-02-28

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.

Conditions

Retinitis Pigmentosa

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

AuTNA I

Intervention Type: DEVICE

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

Interventions

AuTNA I

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

Intervention Type: DEVICE

Eligibility Criteria

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

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: collaborator

Eye & ENT Hospital of Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chunhui Jiang

Role: STUDY_DIRECTOR

Eye and ENT Hospital of Fudan University

Locations

Chunhui Jiang

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Chunhui Jiang

Role: CONTACT

chhjiang70@163.com

+8621-64377134-2501

Facility Contacts

Chunhui Jiang

Role: primary

chhjiang70@163.com

+8621-64377134-2501

Other Identifiers

AuTNA I

Identifier Type: -

Identifier Source: org_study_id