Pilot Study of AuTNA I (Au Nanoparticle-decorated TiO2 Nanowire Arrays, Retinal Prothesis) -a Safety and Efficacy Evaluation.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- FST
研究概览
简要总结
The objective of the study is to evaluate:
- Safety of AuTNA I for subretinal implantation in patients with retinitis pigmentosa;
- Efficacy of AuTNA I for subretinal implantation in patients with retinitis pigmentosa.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 typical fundus changes with both a and b, with or without c:
- •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.
排除标准
- •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.
结局指标
主要结局
FST
时间窗: Baseline and improvement of FST at 3 months.
FST means Full-field Sensitivity Threshold. The thresholds of light with different wavelengths. The exam was performed at baseline and at various time points throughout the first year after the implantation.
BCVA
时间窗: Baseline and improvement of BCVA at 3 months.
BCVA means Best-Corrected Visual Acuity, and is measured by Snellen Chart, EDTRS Chart and charts designed for people with low vision. It's performed at baseline and at various timepoints throughout the first year after the implantation.
Clinical electrophysiology of vision
时间窗: Baseline and improvement of electrophysiology at 3 months.
Electrophysiological examinations of the visual pathway to evaluate the light responsiveness, including VEP, ERG and mfERG (Multifocal ERG). It's performed at baseline and at various timepoints throughout the first year after the implantation.
ElectroEncephaloGram
时间窗: Baseline and change of EEG at 3 months.
EEG(ElectroEncephaloGram) target frequency power amplitude and signal-to-noise ratio (SNR) would be used to analyse the visual stimulus steady-state evoked potential paradigms. It's performed at baseline and at various timepoints throughout the first year after the implantation.
Functional Magnetic Resonance Imaging
时间窗: Baseline and change of fMRI at 3 months.
Using fMRI (Functional Magnetic Resonance Imaging) to measure visual stimulus-induced brain activity caused by changes in blood flow. It's performed at baseline and at various timepoints throughout the first year after the implantation.
次要结局
- Line task(Recruitment (baseline) and 3 months, 6 months and 1 year after implantation.)
- Visual field(Recruitment (baseline) and 3 months, 6 months and 1 year after implantation.)
- VisQoL(Recruitment (baseline) and 3 months, 6 months and 1 year after implantation.)