EUCTR2017-001221-40-DE进行中（未招募）1 期
Safety, tolerability and pharmacodynamics of single rising intravitreal and multiple rising intravitreal doses of BI 836880 in patients with wAMD (open label, non-randomized, uncontrolled).
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 42
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
- •SRD part and MRD cohort 1:
- •- Men and women over the age of 55 with active CNV secondary to AMD despite anti-VEGF therapies (at least 3 prior injections with the last
- •injection within 16 to 4 weeks before treatment).
- •- For MRD cohort 1 only: Central subfield retinal thickness >330 microns in the study eye.
- •- Presence of sub- and/or intraretinal fluid on SD-OCT in the study eye.
- •- Any active CNV with subfoveal leakage in the study eye as determined by OCT.
- •- Best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) VA in the study eye between 70 and 24 letters inclusive (approximately
- •20/40 and 20/320 or 6/12 and 6/95) at screening.
- •- Best-corrected VA in the non-study eye better than best-corrected VA in the study-eye. If both eyes are eligible and have identical VA the
- •investigator may select the study eye.
- •MRD cohort 2:
- •- Men and women over the age of 55 with treatment-naïve CNV secondary to AMD.
- •- Any CNV with subfoveal activity in the study eye defined as evidence of sub- and/or intraretinal fluid, or subretinal hyper-reflective material, or
- •angiographic leakage.
- •- Best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) VA in the study eye between 80 and 24 letters inclusive (approximately
- •20/25 and 20/320 or 6/7.5 and 6/95) at screening.
- •- Best-corrected ETDRS VA in the non-study eye 50 letters inclusive (approximately 20/100 or 6/30) or better at screening.
- •- If both eyes are eligible at screening, the study eye is the eye with the worse best-corrected VA.
- •All trial parts:
- •- No subretinal hemorrhage involving the fovea in the study eye.
- •- No subfoveal fibrosis or atrophy on SD-OCT in the study eye.
- •- Female subjects must be of non-childbearing potential.
- •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 5
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 37
排除标准
- •- Additional eye disease in the study eye that could compromise best corrected VA (BCVA) with visual field loss, uncontrolled glaucoma (IOP>24 mmHg on more than 2 consecutive measurements prior to screening), clinically significant diabetic maculopathy, history of ischemic optic neuropathy or retinalvascular occlusion, symptomatic vitreomacular traction, or genetic disorders such as retinitis pigmentosa);
- •history of high myopia >8 diopters in the study eye. Anterior segment and vitreous abnormalities in the study eye that would preclude adequate observation with SD-OCT.
- •- Any prior intraocular surgery in the study eye other then uneventful lens replacement for cataract within 3 months prior to screening.
- •- Aphakia or total absence of the posterior capsule. Yttrium aluminum garnet (YAG) laser capsulotomy permitted, more than 1 month prior to
- •enrollment in the study eye.
- •- Current or planned use of medications known to be toxic to the retina, lens or optic nerve.
- •- Active intraocular inflammation in the study eye.
- •- Active infectious conjunctivitis in either eye.
- •- Participation in trials:
- •- Previous participation in this trial.
- •- Previous participation in other trials for treatment of wAMD with systemic administration if washout period from last administration is
- •shorter than 3 months.
- •- MRD cohort 1: Previous participation in other trials for treatment of wAMD with IVT injections in the study eye if washout period from last
- •administration/injection is shorter than 3 months (IVT injections allowed if fellow eye was treated).
- •- MRD cohort 2: No previous IVT injections for wAMD in the study eye (IVT injections allowed if fellow eye was treated).
研究者
相似试验
暂停
1 期
A study in healthy Japanese men to test how different doses of BI 894416 are toleratedJPRN-jRCT2080225328ippon Boehringer Ingelheim Co., Ltd.24
招募中
1 期
A study in healthy Japanese men to test how well different dosesof BI 1569912 are toleratedMajor Dipressive DisorderJPRN-jRCT2071210037Furuichi Takumi44
尚未招募
1 期
A study in healthy Japanese men to test how well different doses of BI 764198 are toleratedAJPRN-jRCT2071200055Ogawa Shintaro44
已完成
1 期
A study in healthy Japanese men to test how different doses of BI 1323495 are tolerated and how itraconazole influences the amount of BI 1323495 in the bloodJPRN-jRCT2071200056Katakabe Tetsuya74
进行中（未招募）
不适用
The purpose of this study is to describe the pharmacokinetics of moxifloxacin in children to see what the best dose should be for children in the future. Pharmacokinetics is to see how the body absorbs, distributes, breaks down and gets rid of the study drug.o medical condition specified as the purpose of this study is to describe the pharmacokinetics of moxifloxacin in children for future antibiotic treatment.EUCTR2012-000737-40-Outside-EU/EEABayer HealthCare Pharmaceuticals36