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โ† Trials
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Pilot Study of AuTNA I

RecruitingNAAges 18 Years - 70 YearsAllEye & ENT Hospital of Fudan University
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Age: 18-70 years of age. 2. Clinically diagnosed as retinitis pigmentosa (one of the following two conditions): โ‘  typical triadfundus manifestations: "osteoblastic" pigmentation of retina, arterial stenosis, and waxy atrophy of optic disc. โ‘ก typical fundus changes with both a and b, with or without c: 1. poor night vision before vision loss; 2. standard 5 ERG examination showing more severely damaged scotopic response than photopic, even non response 3. impaired peripheral visual field in perimetry (when the patient's vision permits). 3. No or suspicious light perception in the eye for AuTNA I implantation. 4. Intact inner retinal structure on OCT. No macular retinal or choroidal neovascularization. 5. Voluntary to participate in the study and sign the informed consent. Exclusion Criteria: 1. Entities that might interfere with the functioning of AuTNA I, e.g. open ocular trauma, retinal detachment, glaucoma, severe uveitis, etc. 2. Uncontrolled systemic diseases including hypertension (systolic blood pressure โ‰ฅ160mmHg and/or diastolic blood pressure โ‰ฅ100mmHg), diabetes (blood glucose โ‰ฅ8.0mmol/L with medication); 3. Allergic constitution. 4. Entities that might prevent the observation of the fundus, e.g. corneal opacity, etc. 5. Ocular disease not suitable for undertaking the implantation surgery, e.g. corneal ulcers, etc. 6. Habits of rubbing the eyes. 7. 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). 8. Pregnancy, lactating or planning to be pregnant within 6 months. 9. History of epilepsy or serious psychiatric diseases. 10. Other local or systemic diseases that may affect the vision. 11. Participation in other clinical trials within 1 month before this study. 12. Other conditions that the researcher found imporper to be included into this study.
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What it tests

  • AuTNA I
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Where

1 site
Chunhui Jiang
Shanghai, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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