Pilot Study of AuTNA I
ConditionRetinitis Pigmentosa
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorEye & ENT Hospital of Fudan University
About this trial
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
Qualifiers
Age: 18-70 years of age.
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).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- AuTNA I
Treatment groups
7 Participants
are divided into 1 treatment groupSponsors and collaborators
Eye & ENT Hospital of Fudan University
Lead sponsor
Fudan University
Collaborator
Source ClinicalTrials.gov