Evaluating a new treatment for retinitis pigmentosa

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Chunhui Jiang
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Chunhui Jiang
• Email: chhjiang70@163.com
• Phone: +8621-64377134-2501

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Functional visual field and navigation testing for moderate-to-profound inherited retinal disease

  This project will test whether functional visual field and navigation tests can measure real-world vision and mobility in people with moderate-to-profound inherited retinal diseases.

  Recruiting Ray Therapeutics, Inc. · Irvine, California · NCT07502664

• OCT-980 oral treatment for rhodopsin-associated autosomal dominant retinitis pigmentosa

  This program will test whether the oral drug OCT-980 is safe, well tolerated, and shows signs of benefit in adults with RHO-associated autosomal dominant retinitis pigmentosa and in healthy volunteers.

  Recruiting at 2 sites Phase 1/2 Octant, Inc. · Portland, Oregon and 1 other locations · NCT07408232

• Course of EYS-associated retinitis pigmentosa in adults from Russia and former CIS

  We will follow adults with pathogenic EYS gene variants from Russia and former CIS for four years to try to find reliable vision and retinal measures for future treatments.

  Recruiting Sensor Technology for Deafblind · Moscow · NCT07228793

• ZVS203e eye gene-editing therapy for a specific RHO-related retinitis pigmentosa

  This trial tests a single subretinal injection of ZVS203e to see if it’s safe and can help a specific RP caused by an RHO mutation.

  Recruiting Phase 1/2 Chigenovo Co., Ltd · Beijing, Beijing Municipality · NCT06952842

• Testing IGT001 for treating Retinitis Pigmentosa

  This study is testing a new treatment called IGT001 for people with retinitis pigmentosa to see if it can help improve their vision and how safe it is to use.

  Recruiting Phase 1 Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Shanghai · NCT06936787

• Safety of a one-time DSP-3077 retinal sheet injection in adults with retinitis pigmentosa

  This will test whether a single subretinal injection of DSP-3077 retinal sheets is safe and well tolerated in adults with retinitis pigmentosa.

  Recruiting at 2 sites Phase 1/2 Sumitomo Pharma America, Inc. · Boston, Massachusetts and 1 other locations · NCT06891885

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.