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Pilot Study of AuTNA I

Primary Purpose

Retinitis Pigmentosa

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
AuTNA I
Sponsored by
Eye & ENT Hospital of Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Retinitis Pigmentosa

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age: 18-60 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.

Sites / Locations

  • Chunhui JiangRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Implant AuTNA I

Arm Description

This is a single arm study where the status and performance of the implanted eye prior to the surgery serves as the comparator.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
April 15, 2023
Last Updated
May 2, 2023
Sponsor
Eye & ENT Hospital of Fudan University
Collaborators
Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT05853107
Brief Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 12, 2023 (Anticipated)
Primary Completion Date
February 28, 2026 (Anticipated)
Study Completion Date
February 28, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eye & ENT Hospital of Fudan University
Collaborators
Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The objective of the study is to evaluate: Safety of AuTNA I for subretinal implantation in patients with retinitis pigmentosa; 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinitis Pigmentosa

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Implant AuTNA I
Arm Type
Experimental
Arm Description
This is a single arm study where the status and performance of the implanted eye prior to the surgery serves as the comparator.
Intervention Type
Device
Intervention Name(s)
AuTNA I
Intervention Description
AuTNA I means Au nanoparticle-decorated TiO2 Nanowire Arrays, a retinal prothesis designed for subretinal implantation.
Primary Outcome Measure Information:
Title
FST
Description
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.
Time Frame
Baseline and improvement of FST at 3 months.
Title
BCVA
Description
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.
Time Frame
Baseline and improvement of BCVA at 3 months.
Title
Clinical electrophysiology of vision
Description
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.
Time Frame
Baseline and improvement of electrophysiology at 3 months.
Secondary Outcome Measure Information:
Title
Visual field
Description
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.
Time Frame
Recruitment (baseline) and 3 months, 6 months and 1 year after implantation.
Title
Line task
Description
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.
Time Frame
Recruitment (baseline) and 3 months, 6 months and 1 year after implantation.
Title
VisQoL
Description
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.
Time Frame
Recruitment (baseline) and 3 months, 6 months and 1 year after implantation.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age: 18-60 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chunhui Jiang
Phone
+8621-64377134-2501
Email
chhjiang70@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chunhui Jiang
Organizational Affiliation
Eye and ENT Hospital of Fudan University
Official's Role
Study Director
Facility Information:
Facility Name
Chunhui Jiang
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chunhui Jiang
Phone
+8621-64377134-2501
Email
chhjiang70@163.com

12. IPD Sharing Statement

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Pilot Study of AuTNA I

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