Testing a Retinal Implant Device for Retinitis Pigmentosa
Tests a subretinal implant device for safety and effect in adults with retinitis pigmentosa.
Plain-language title generated from the registry record
Registry title: Pilot Study of AuTNA I
Key facts
- Where
- Shanghai, ChinaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT05853107, who can take part
Where in China
- Chunhui JiangShanghai, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Eye & ENT Hospital of Fudan University
- Trial code
- NCT05853107
- Record updated
- 19 September 2025
- Original description
The objective of the study is to evaluate:Read full original descriptionShow less
Pilot Study of AuTNA I (Au Nanoparticle-decorated TiO2 Nanowire Arrays, Retinal Prothesis) -a Safety and Efficacy Evaluation.
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.
Inclusion: 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: Participation in other clinical trials within 1 month before this study; Allergic constitution; Ocular disease not suitable for undertaking the implantation surgery, e.g. corneal ulcers, etc; History of epilepsy or serious psychiatric diseases; Other local or systemic diseases that may affect the vision; Other conditions that the researcher found imporper to be included into this study; Uncontrolled systemic diseases including hypertension (systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥100mmHg), diabetes (blood glucose ≥8.0mmol/L with medication); 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); Entities that might interfere with the functioning of AuTNA I, e.g. open ocular trauma, retinal detachment, glaucoma, severe uveitis, etc; Entities that might prevent the observation of the fundus, e.g. corneal opacity, etc; Habits of rubbing the eyes; Pregnancy, lactating or planning to be pregnant within 6 months.