Pilot Study of AuTNA I

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

• FST [Time frame: Baseline and improvement of FST at 3 months.]
• BCVA [Time frame: Baseline and improvement of BCVA at 3 months.]
• Clinical electrophysiology of vision [Time frame: Baseline and improvement of electrophysiology at 3 months.]
• ElectroEncephaloGram [Time frame: Baseline and change of EEG at 3 months.]
• Functional Magnetic Resonance Imaging [Time frame: Baseline and change of fMRI at 3 months.]

Secondary outcome measures (3)

• Visual field [Time frame: Recruitment (baseline) and 3 months, 6 months and 1 year after implantation.]
• Line task [Time frame: Recruitment (baseline) and 3 months, 6 months and 1 year after implantation.]
• VisQoL [Time frame: Recruitment (baseline) and 3 months, 6 months and 1 year after implantation.]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Chunhui Jiang — Shanghai

Identifiers

NCT: NCT05853107 · AuTNA I

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗