EUCTR2018-003817-16-DE进行中（未招募）1 期
A 52 weeks double blind, randomized and placebo controlled trial evaluating the effect of oral KIN001 150 mg plus pioglitazone 10 mg daily on injection frequency of Standard of Care in patients with diagnosed unilateral wet AMD undergoing a treat and extend regimen - Kinarus wet AMD treat and extend study
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Kinarus AG
- 入组人数
- 100
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. Male or female patients with confirmed diagnosis of unilateral wet AMD
- •2. Patients on SOC treatment for at least 9 months having failed two attempts to extend to a 6-week treatment interval, where failure is defined as having at least one of the following signs of disease activity of the choroidal neovascularization after the 6 week interval
- •a. Recurrent or new intra- or subretinal fluid
- •b. New macular haemorrhage
- •c. New choroidal neovascularization
- •3. Patients with Type III choroidal neovascular/retinal angiomatous proliferating (RAP) lesions are allowed for participation in the study. Randomization will be stratified.
- •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 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 80
排除标准
- •1. Patients = 50 years of age
- •2. Advanced fibrosis (more than 50% of the total lesion size on fluorescein angiography)
- •3. Fibrosis affecting the fovea as defined by SD-OCT
- •4. Subretinal hemorrhage of ?50% of the lesion area and atrophy
- •5. Retinal pigment epithelium rupture
- •6. BCVA letter score < 23 ETDRS letters
- •7. Concurrent conditions compromising visual acuity requiring medical or surgical intervention
- •8. Ocular media disturbing imaging (significant vitreous opacity or cataract)
- •9. Myopia of more than 6 dpt
- •10. Surgical intraocular intervention within 3 months prior to baseline
- •11. Patients who are being treated or were treated with pioglitazone or rosiglitazone, immunosuppresants (including oral corticosteroids >7.5mg/day) or gemfibrozil and rifampicin within 4 weeks prior randomization
- •12. Patients where oral administration of pioglitazone is contraindicated (i.e. cardiac failure or history of cardiac failure (NYHA stages I to IV), hepatic impairment, diabetic ketoacidosis, current bladder cancer or a history of bladder cancer, uninvestigated macroscopic haematuria
- •13. Any severe, progressive or uncontrolled medical condition at baseline that in the judgment of the investigator prevents the patient from participating in the study
- •14. Patients treated with insulin secretagogues
- •15. Patients with known hypersensitivities to the active substance or any of the ingredients
- •16. Any clinically significant abnormal laboratory tests at screening
- •17. Any other investigational treatment for wet AMD in the last 3 months prior to baseline
研究者
相似试验
进行中（未招募）
不适用
A 52 weeks, double blind, randomized, placebo-controlled trial evaluating the effect of oral BIBF 1120, 150 mg twice daily, on Forced Vital Capacity decline , in patients with Idiopathic Pulmonary Fibrosis (IPF)Idiopathic Pulmonary FibrosisEUCTR2010-024252-29-FIBoehringer Ingelheim485
进行中（未招募）
不适用
A 52 weeks, double blind, randomized, placebo-controlled trial evaluating the effect of oral BIBF 1120, 150 mg twice daily, on Forced Vital Capacity decline , in patients with Idiopathic Pulmonary Fibrosis (IPF)MedDRA version: 14.0Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersIdiopathic Pulmonary FibrosisEUCTR2010-024252-29-PTBoehringer Ingelheim France485
进行中（未招募）
不适用
Safety and Efficacy of BIBF 1120 at high dose in Idiopathic Pulmonary Fibrosis patientsIdiopathic Pulmonary FibrosisEUCTR2010-024252-29-DEBoehringer Ingelheim Pharma GmbH & Co. KG485
进行中（未招募）
1 期
Safety and efficacy of BIBF 1120 at high dose in Idiopathic Pulmonary Fibrosis patientsMedDRA version: 14.1Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersIdiopathic Pulmonary FibrosisEUCTR2010-024251-87-GBBoehringer Ingelheim Limited485
进行中（未招募）
不适用
Safety and Efficacy of BIBF 1120 at high dose in Idiopathic Pulmonary Fibrosis patientsMedDRA version: 14.1Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersIdiopathic Pulmonary FibrosisEUCTR2010-024251-87-CZBoehringer Ingelheim RCV GmBH & Co KG485