EUCTR2016-003705-34-DE进行中（未招募）1 期
PIGMENT – PDE6A gene therapy for retinitis pigmentosa
niversitätsklinikum Tübingen0 个研究点目标入组 9 人开始时间: 2018年11月26日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 9
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
- 性别
- All
入选标准
- •clinical diagnosis of retinitis pigmentosa
- •confirmed mutation in PDE6A gene
- •= 18 years of age
- •visual acuity = 20/400
- •no infection with Human Immundeficiency Virus (HIV)
- •negative pregnancy test in women with childbearing potential (a woman who is two years post-menopausal or surgically sterile is not considered to be of childbearing potential)
- •Male patients must agree to use condoms during the first 6 months post treatment.
- •Female patients of childbearing potential must agree to use an effective method of birth control during the first 6 months post treatment.
- •ability to understand and willingness to consent to study protocol
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 9
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 9
排除标准
- •Ocular (study eye & fellow eye)
- •additional interfering ocular conditions with impact on study results (e.g. ocular opacity and advanced cataract, uveitis, amblyopia)
- •recent (6 months) ocular surgery, intravitreal or subretinal implantation of a medical device
- •disease causing mutations in another known retinitis pigmentosa gene
- •ocular infection with herpes simplex virus in medical history
- •history of ocular malignancies
- •disorders of the internal retina (e.g. retinal detachment in the patients history)
- •glaucoma defined as damage of the optic nerve
- •vascular retinal occlusion
- •diabetic patients suffering from retinopathy and/or macula edema
- •any other retinopathy due to other diseases e.g. (but not limited to) arterial hypertension, trauma or acquired inflammatory diseases (uveitis serology), contraindication to pharmacological mydriasis (e.g. history of angle block glaucoma)
- •absence of visual function on the contralateratel eye
- •systemic conditions (e.g. coronary heart disease, autoimmune disorders) which may affect study participation or outcome measures
- •history of poorly controlled Diabetes Mellitus type 1 or type 2
- •systemic illness or medically relevant abnormal laboratory values in blood analysis including renal and hepatic functions at inclusion
- •patients treated with oral corticoids within 14 days prior inclusion
- •current or recent participation in other study/or administration of biologic agent within the last three months
- •known sensitivity to any compound used in the study
- •contraindications to systemic immunosuppression
- •contraindications in view of the planned surgery (e.g. but not limited to anaemia Hb<10g/dl, coagulopathy with PT/PTT >1,5 fold upper limit, hypertension with values above 180 mmHg systolic and 110 mmHg diastolic) including intolerance and contraindications to general anaesthesia
- •intolerance to contrast agents used for diagnostic methods like angiography with fluoresceine or indocyanine green (e.g. but not limited to hyperthyroidism, hepatic insufficiency)
- •subject/partner of childbearing potential unwilling to use adequate contraception for four months
- •nursing or pregnant women
- •any other cause that, in the investigator‘s opinion, renders potential subjects not suitable for the study
研究者
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