EUCTR2013-004203-39-CZ进行中（未招募）1 期
A randomized, 12 months, active controlled study of the efficacy of repeated doses of intravitreal aflibercept in subjects with prolipherative diabetic retinopathy
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 50
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
- •1.Adults = 18 years with type 1 or 2 diabetes mellitus.
- •2.Subjects with PDR secondary to diabetes mellitus ( confirmed on fluorescein angiography FA)
- •3.BCVA ETDRS letter score of 20/20 to 20/320 in the study eye
- •4.Willing and able to comply with clinic visits and study-related procedures.
- •5.Provide a signed informed consent form (ICF)
- •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 25
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •A subject who meets any of the following criteria will be excluded from the study.
- •1.Decrease in vision determined to be primarily the result of DME in the study eye
- •2.Laser quadrant or panretinal photocoagulation in the study eye
- •3.Previous treatment with anti-antiangiogenic drugs in study eye (pegaptanib sodium, bevacizumab, ranibizumab etc.) within 90 days of Baseline visit
- •4.Proliferative diabetic retinopathy in the study eye, with the inactive, regressed vessels
- •5.Any intraocular surgery within 28 days of Baseline visit in the study eye
- •6.Presence of tractional or rhegmatogenous retinal detachment in the study eye
- •7.Any active ocular or/and periocular inflammation or infection in the study eye at Screening or Baseline visits
- •8.Intraocular pressure (IOP) = 30 mmHg in the study eye at Screening or Baseline visits
- •9.Concurrent disease in the study eye, other than PDR, that could require medical or surgical intervention during the study period, or could confound interpretation of the results (including retinal vascular occlusion, retinal detachment, macular hole, or choroidal neovascularization of any cause)
- •10.Ocular media of insufficient quality to obtain fundus images and ERG (e.g., cataract, corneal opacity, severe vitreous haemorrhage)
- •11.Uncontrolled blood pressure defined as systolic value of >160 mmHg or diastolic value >100 mmHg eye at Screening or Baseline visits
- •12.Stroke or and/or myocardial infarction less than 3 months prior to Baseline visit
- •13.Pregnant or breast-feeding women.
- •14.Hypersensitivity to aflibercept or to fluorescein
研究者
相似试验
已完成
4 期
Visual Field Assessment With Subjects Who Receive Either Lyrica Or Sugar PillsCTRI/2009/091/000872Pfizer Limited29
已完成
不适用
Optimal diet patterns for improving muscle strength in older adultsoss of muscle mass and strength in agingLoss of muscle mass and strength in agingMusculoskeletal - Other muscular and skeletal disordersACTRN12612000177853niversity of South Australia135
已完成
不适用
Are eggs good for people with type 2 diabetes?Type 2 diabetesDiet and Nutrition - ObesityMetabolic and Endocrine - DiabetesACTRN12612001266853Australian Egg Corporation140
已完成
不适用
A 12 month randomised controlled trial to determine biomarkers from the gut microbiota as management tools for overweight and obesityOverweight and obesityDiet and Nutrition - ObesityACTRN12612000603819The University of Sydney108
进行中（未招募）
1 期
A 12-month prospective, randomized, interventional, global, multi-center, active-controlled study comparing sustained benefit of two treatment paradigms in adult episodic migraine patientsMedDRA version: 20.0Level: PTClassification code 10027599Term: MigraineSystem Organ Class: 10029205 - Nervous system disordersMigraine preventionEUCTR2018-001228-20-DEovartis Pharma AG600