Actively Recruiting
Pilot Study of AuTNA I
Led by Eye & ENT Hospital of Fudan University · Updated on 2025-09-19
7
Participants Needed
1
Research Sites
146 weeks
Total Duration
On this page
Sponsors
E
Eye & ENT Hospital of Fudan University
Lead Sponsor
F
Fudan University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Pilot Study of AuTNA I
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 70 years
- Clinically diagnosed with retinitis pigmentosa based on specific retinal changes
- No or suspicious light perception in the eye selected for AuTNA I implantation
- Intact inner retinal structure on OCT with no macular retinal or choroidal neovascularization
- Willing to participate and able to sign informed consent
You will not qualify if you...
- Conditions interfering with AuTNA I function such as ocular trauma, retinal detachment, glaucoma, or severe uveitis
- Uncontrolled systemic diseases including hypertension and diabetes
- Allergic constitution
- Conditions preventing fundus observation like corneal opacity
- Ocular diseases unsuitable for implantation surgery such as corneal ulcers
- Habit of rubbing the eyes
- Compromised liver, kidney, or coagulation functions
- Pregnancy, lactation, or planning pregnancy within 6 months
- History of epilepsy or serious psychiatric illness
- Other diseases affecting vision
- Participation in other clinical trials within 1 month
- Any other conditions deemed inappropriate by the researcher
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Chunhui Jiang
Shanghai, Shanghai Municipality, China, 200030
Actively Recruiting
Research Team
C
Chunhui Jiang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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