Pilot Study of AuTNA I

Last updated: September 18, 2024
Sponsor: Eye & ENT Hospital of Fudan University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Retinitis Pigmentosa

Posterior Uveitis

Eye Disorders/infections

Treatment

AuTNA I

Clinical Study ID

NCT05853107
AuTNA I
  • Ages 18-65
  • All Genders

Study 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

Inclusion Criteria:

  1. Age: 18-65 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 thanphotopic, even non response

  3. impaired peripheral visual field in perimetry (when the patient's visionpermits).

  4. No or suspicious light perception in the eye for AuTNA I implantation.

  5. Intact inner retinal structure on OCT. No macular retinal or choroidalneovascularization.

  6. Voluntary to participate in the study and sign the informed consent.

Exclusion

Exclusion Criteria:

  1. Entities that might interfere with the functioning of AuTNA I, e.g. open oculartrauma, 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. cornealulcers, etc.

  6. Habits of rubbing the eyes.

  7. Compromised liver function (ALT and AST 1.5 times over the normal limits), renalfunction (Cr 1.5 times over the normal limits), coagulation function (APTT 1.5 timesover 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.

Study Design

Total Participants: 7
Treatment Group(s): 1
Primary Treatment: AuTNA I
Phase:
Study Start date:
May 12, 2023
Estimated Completion Date:
February 28, 2026

Study Description

In this study, AuTNA I (nanoparticle-decorated TiO2 Nanowire Arrays), which is designed to replace the damaged photoreceptors in RP patients, was implanted in one eye of the subjects. The change or improvement in the visual acuity of the subjects, as well as the potential side effects, was then fully evaluated.

Connect with a study center

  • Chunhui Jiang

    Shanghai, Shanghai 200030
    China

    Active - Recruiting

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