Clinical trial NCT05853107: Pilot Study of AuTNA I
Official title: Pilot Study of AuTNA I (Au Nanoparticle-decorated TiO2 Nanowire Arrays, Retinal Prothesis) -a Safety and Efficacy Evaluation.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Retinitis Pigmentosa
Lead sponsor: Eye & ENT Hospital of Fudan University
Sponsor class: OTHER
Collaborators: name: Fudan University
First posted: 2023-05-10
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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 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.

Primary outcomes:
measure: FST
timeFrame: Baseline and improvement of FST at 3 months.
measure: BCVA
timeFrame: Baseline and improvement of BCVA at 3 months.
measure: Clinical electrophysiology of vision
timeFrame: Baseline and improvement of electrophysiology at 3 months.
measure: ElectroEncephaloGram
timeFrame: Baseline and change of EEG at 3 months.
measure: Functional Magnetic Resonance Imaging
timeFrame: Baseline and change of fMRI at 3 months.
Secondary outcomes:
measure: Visual field
timeFrame: Recruitment (baseline) and 3 months, 6 months and 1 year after implantation.
measure: Line task
timeFrame: Recruitment (baseline) and 3 months, 6 months and 1 year after implantation.
measure: VisQoL
timeFrame: Recruitment (baseline) and 3 months, 6 months and 1 year after implantation.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Chunhui Jiang
state: Shanghai
Study officials:
affiliation: Eye and ENT Hospital of Fudan University
name: Chunhui Jiang
role: STUDY_DIRECTOR
References: