Evaluating a new treatment for retinitis pigmentosa

Pilot Study of AuTNA I (Au Nanoparticle-decorated TiO2 Nanowire Arrays, Retinal Prothesis) -a Safety and Efficacy Evaluation.

This study is testing a new eye implant to see if it can help improve vision in people with retinitis pigmentosa.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 7 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Eye & ENT Hospital of Fudan University (Academic / other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT05853107 on ClinicalTrials.gov

What this trial studies

This study aims to assess the safety and efficacy of AuTNA I, a nanoparticle-decorated TiO2 Nanowire Array, for subretinal implantation in patients diagnosed with retinitis pigmentosa. Participants aged 18-65 will receive the implant in one eye, and their visual acuity changes, along with any potential side effects, will be closely monitored. The study focuses on patients with specific retinal conditions and intact inner retinal structures to ensure the best outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-65 with a clinical diagnosis of retinitis pigmentosa and specific retinal characteristics.

Not a fit: Patients with conditions that could interfere with the implant's function, such as open ocular trauma or severe uveitis, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve vision for patients suffering from retinitis pigmentosa.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in the field of retinal implants, suggesting potential for success.

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.

Where this trial is running

Shanghai, Shanghai Municipality

• Chunhui Jiang — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Chunhui Jiang

Conditions Retinitis Pigmentosa