BridgeMD
New treatment option for Retinitis Pigmentosa
Official title Pilot Study of AuTNA I
ClinicalTrials.gov ID: NCT05853107
What this study is testing
- What it's testing
- The objective of the study is to evaluate: 1. Safety of AuTNA I for subretinal implantation in patients with retinitis pigmentosa; 2.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Age: 18-70 years of age.
- Clinically diagnosed as retinitis pigmentosa (one of the following two conditions): ① typical triadfundus manifestations: "osteoblastic" pigmentation...
- 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).
You likely can't join if
- 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...
- Allergic constitution.
- Entities that might prevent the observation of the fundus, e.g. corneal opacity, etc.
- Ocular disease not suitable for undertaking the implantation surgery, e.g. corneal ulcers, etc.
- Habits of rubbing the eyes.
See the full eligibility criteria
- Age: 18-70 years of age.
- 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...
- 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).
- No or suspicious light perception in the eye for AuTNA I implantation.
- Intact inner retinal structure on OCT. No macular retinal or choroidal neovascularization.
- Voluntary to participate in the study and sign the informed consent.
- 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.
- Ocular disease not suitable for undertaking the implantation surgery, e.g. corneal ulcers, etc.
- Habits of rubbing the eyes.
- 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).
- Pregnancy, lactating or planning to be pregnant within 6 months.
- History of epilepsy or serious psychiatric diseases.
- Other local or systemic diseases that may affect the vision.
- Participation in other clinical trials within 1 month before this study.
- Other conditions that the researcher found imporper to be included into this study.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.