Pilot Study of AuTNA I
ConditionRetinitis Pigmentosa
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorEye & ENT Hospital of Fudan University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age: 18-70 years of age.
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).
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
AuTNA I
DeviceAuTNA I means Au nanoparticle-decorated TiO2 Nanowire Arrays, a retinal prothesis designed for subretinal implantation.
Treatment groups
7 Participants
are divided into 1 treatment groupGroup A: Implant AuTNA IExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline and improvement of FST at 3 months.2
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.
Time frame
Baseline and improvement of BCVA at 3 months.3
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.
Time frame
Baseline and improvement of electrophysiology at 3 months.4
ElectroEncephaloGram
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.
Time frame
Baseline and change of EEG at 3 months.Secondary outcomes
1
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.
Time frame
Recruitment (baseline) and 3 months, 6 months and 1 year after implantation.2
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.
Time frame
Recruitment (baseline) and 3 months, 6 months and 1 year after implantation.3
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.
Time frame
Recruitment (baseline) and 3 months, 6 months and 1 year after implantation.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Eye & ENT Hospital of Fudan University
Lead sponsor
Fudan University
Collaborator
Source ClinicalTrials.gov