Pilot Study of AuTNA I
Recruiting now · Not applicable
Conditions studied: Retinitis Pigmentosa
In brief
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.
Key facts
- Study ID
- NCT05853107
- Run by
- Eye & ENT Hospital of Fudan University
- People needed
- 7
- Starts
- 2023-05-12
- Expected to finish
- 2026-02-28
- Last updated by the study team
- 2025-09-19
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Chunhui Jiang — Shanghai, Shanghai Municipality, China (enrolling)
Full record on ClinicalTrials.gov
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