CTIS2024-515553-17-00招募中1 期
Safety and efficacy of a bilateral single subretinal injection of rAAV.hCNGA3 in adult and minor patients with CNGA3-linked achromatopsia investigated in a randomized, wait list controlled, observer-masked trial (Colour Bridge) - RDC-CNGA3-01
niversitaetsklinikum Tuebingen AöR0 个研究点目标入组 14 人开始时间: 2024年7月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 14
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 年龄范围
- 0 至 65+（—）
- 性别
- All
入选标准
- •clinical diagnosis of achromatopsia, Female patients of childbearing potential must agree to use an effective method ofbirth control during the first 6 months post treatment., negative pregnancy test in women with childbearing potential (a woman who istwo years post-menopausal or surgically sterile is not considered to be ofchildbearing potential), 6-12 years of age, = 18 years of age, bi-allelic pathogenic or likely pathogenic mutation in CNGA3, BCVA = 20/400, a minimal outer nuclear layer thickness of 10µm at 3° eccentricity (normal =38±6µm), ability to understand and willingness to consent to study protocol, no infection with Human Immundeficiency Virus (HIV), Male patients must agree to use condoms during the first 6 months post treatment.
排除标准
- •any other retinopathy due to other diseases e.g. (but not limited to) arterialhypertension, trauma or acquired inflammatory diseases (uveitis serology) ,retinopathy of the premature, causal mutations in other genes for hereditary retinal diseases, contraindications in view of the planned surgery (e.g. anaemia Hb<8g/dl, severecoagulopathy, severe blood pressure fluctuations) including intolerance andcontraindications to general anaesthesia, ocular opacity and mature cataract, ocular infection with herpes simplex virus in medical history, history of ocular malignancies, disorders of the inner retina (e.g. retinal vascular occlusions in the patients history), glaucoma defined as damage of the optic nerve, history of poorly controlled (HbA1c > 7%) Diabetes Mellitus type 1 or type 2, patients treated with systemic corticoids within 14 days prior inclusion, systemic illness or medically significant abnormal laboratory values >3 UNL in bloodanalysis including renal and hepatic functions at inclusion, systemic conditions (e.g. coronary heart disease, congenital/genetic conditions,autoimmune disorders) which may affect study participation or outcome measures, absence of vision on the contralateral eye, contraindication to pharmacological mydriasis (e.g. history of angle blockglaucoma), current or recent participation in other study or administration of biologic agentwithin the last three months, recent (within the last 6 months) ocular surgery, intravitreal or subretinalimplantation of a medical device, known sensitivity to any compound used in the study, contraindications to systemic immunosuppression, subject/partner of childbearing potential unwilling to use adequate contraceptionfor six months after dosing, nursing or pregnant female subject, any other cause that, in the investigator‘s opinion, renders potential subjects notsuitable for the study
研究者
相似试验
进行中（未招募）
1/2 期
Safety and efficacy of a bilateral single subretinal injection of rAAV.hCNGA3 in adult and minor patients with CNGA3-linked achromatopsia investigated in a randomized, wait list controlled, observer-masked trial2024-515553-17-00Universitaetsklinikum Tuebingen AöR14
进行中（未招募）
1 期
Safety and Efficacy of rAAV.hCNGA3 Gene Therapy in Patients With CNGA3-linked AchromatopsiaAchromatopsiaNCT02610582STZ eyetrial13
招募中
1 期
Safety and Efficacy of a Unilateral Subretinal Administration of HORA PDE6B in Patients with Retinitis Pigmentosa Harbouring Mutations in the PDE6B Gene Leading to a Defect in PDE6ß Expressioretinitis pigmentosaMedDRA version: 20.0Level: PTClassification code: 10038914Term: Retinitis pigmentosa Class: 100000004850CTIS2024-511687-90-00eyeDNA Therapeutics23
招募中
2 期
Safety and Efficacy of a Unilateral Subretinal Administration of HORA PDE6B in Patients with Retinitis Pigmentosa Harbouring Mutations in the PDE6B Gene Leading to a Defect in PDE6ß Expression2024-511687-90-00eyeDNA Therapeutics23
招募中
不适用
Single tube drainage versus double tube drainage for reduction of jaundice in cancers of bile duct.CTRI/2015/04/005725nil120