| NCT ID | NCT05853107 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Eye & ENT Hospital of Fudan University |
| Condition | Retinitis Pigmentosa |
| Study Type | INTERVENTIONAL |
| Enrollment | 7 participants |
| Start Date | 2023-05-12 |
| Primary Completion | 2026-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 7 participants in total. It began in 2023-05-12 with a primary completion date of 2026-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: 1. Age: 18-70 years of age. 2. 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: 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 ≥160mmHg and/or diastolic blood pressure ≥100mmHg), diabetes (blood glucose ≥8.0mmol/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.
Contact & Investigator
Chunhui Jiang
STUDY DIRECTOR
Eye and ENT Hospital of Fudan University
Frequently Asked Questions
Who can join the NCT05853107 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Retinitis Pigmentosa. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05853107 currently recruiting?
Yes, NCT05853107 is actively recruiting participants. Contact the research team at chhjiang70@163.com for enrollment information.
Where is the NCT05853107 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT05853107 clinical trial?
NCT05853107 is sponsored by Eye & ENT Hospital of Fudan University. The principal investigator is Chunhui Jiang at Eye and ENT Hospital of Fudan University. The trial plans to enroll 7 participants.