EUCTR2016-004608-78-AT进行中（未招募）1 期
The Effect of Intravitreal Aflibercept on Ocular Perfusion – a Pilot Study
Kepler University Hospital, Institute of Ophthalmology0 个研究点开始时间: 2017年1月23日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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
- •- Men and women aged over 50 years
- •- If patient is a woman – post-menopausal (final menstruation period at least 3 years before Screening visit)
- •- written informed consent for participation in the study
- •- Scheduled for 3 consecutive intravitreal injections (4 week intervals) of aflibercept for treatment of exudative AMD in one eye
- •- Subject is generally healthy with no current significant or a history of a significant neurological, cardiovascular, pulmonary (including asthma), hepatic, metabolic, rheumatic, autoimmune, hematological or renal disorder, as determined by the investigator’s clinical judgment through collection of medical history and performance of a physical examination. A significant disorder is defined as a disease or medical condition associated with impaired health status, requiring regular or current medical treatment and/or follow up. For the purposes of this study, an investigator may classify a medical condition as a nonsignificant disorder despite the fact that the subject receives treatment. Subjects having controlled Stage 1 hypertension (blood pressure of 140-159 mmHg systolic and/or 90-99 mmHg diastolic) are eligible for participation in this study.
- •- Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant
- •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 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •- Active exudative AMD requiring treatment of both eyes
- •- Ocular surgery (including intravitreal injection) during the 3 months preceding the study
- •- Vitrectomized eyes
- •- History of diabetes
- •- Ametropia > 6 Dpt
- •- Relevant ophthalmic diseases/conditions that could interfere with LSFG measurements (e.g. glaucoma, optic nerve head drusen, tilted disc, etc.)
- •- Ocular infection or clinically significant inflammation
- •- Opacities of the cornea (e.g. corneal scars, corneal oedema), the lens (e.g. LOCS-II grading > 2, posterior capsule opacification) or the vitreous (e.g. vitreous haemorrhage, asteroid hyalosis)
- •- Patients who are not able to cooperate or with insufficient ability to fixate (tremor, nystagmus)
- •- Blood donation in the 3 weeks preceding the study
- •- Participation in a clinical trial in the 3 weeks preceding the study
- •- Pre- or perimenopausal women
研究者
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