RecruitingNot ApplicableNCT05853107
Pilot Study of AuTNA I
Pilot Study of AuTNA I (Au Nanoparticle-decorated TiO2 Nanowire Arrays, Retinal Prothesis) -a Safety and Efficacy Evaluation.
Sponsor
Eye & ENT Hospital of Fudan University
Enrollment
7 participants
Start Date
May 12, 2023
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 18 YearsMax Age: 70 Years
Inclusion Criteria10
- 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 Criteria12
- 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.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
DEVICEAuTNA I
AuTNA I means Au nanoparticle-decorated TiO2 Nanowire Arrays, a retinal prothesis designed for subretinal implantation.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05853107
Related Trials
A Phase II Study of Intravitreal KIO-301 in Patients With Late-stage Retinitis Pigmentosa
NCT066289475 locations
Cell Collection to Study Eye Diseases
NCT014328471 location
Natural History Study of Patients With EYS-Associated RP
NCT072287931 location
Rod and Cone Mediated Function in Retinal Disease
NCT026179661 location
A Study to Investigate the Safety of DSP-3077 After a Unilateral Eye Injection in Male and Female Participants 18 Years of Age or Older With Retinitis Pigmentosa
NCT068918852 locations