EUCTR2013-004567-30-DE进行中（未招募）1 期
A single arm open label study to evaluate the pharmacodynamics and safety of a 4 wk treatment with BI 144807 in patients with newly diagnosed wet age related macular degeneration (wAMD)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
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. Men and women with newly diagnosed unilateral active choroidal neovascularization secondary to AMD
- •2. No prior treatment for neovascular AMD in the study eye and no current or planned concomitant intravitreal anti-vascular endothelial growth factor treatment in the fellow eye
- •3. Central subfield retinal thickness = 250 µm
- •4. Presence of sub- and/or intraretinal fluid on SD-OCT
- •5. Any active CNV with subfoveal leakage
- •6. Total lesion size not greater than 12 disc areas
- •7. No subretinal hemorrhage involving the fovea, if the size of hemorrhage is > 50% of the total lesion area
- •8. No subfoveal fibrosis or atrophy
- •9. Best-corrected ETDRS visual acuity in the study eye between 80 and 24 letters inclusive (approximately 20/25 and 20/320 or 4/5 and 4/63) at screening
- •10. Patients 50 years of age or older
- •11. Female subjects must be of non-childbearing potential
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •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 50
排除标准
- •1. Additional eye disease that could compromizse best corrected visual acuity, such as uncontrolled glaucoma
- •2. The presence of polypoidal choroidal vasculopathy or retinal angiomatous proliferation in the study eye
- •3. Anterior segment and vitreous abnormalities in the study eye that would preclude adequate observation
- •4. Intraocular surgery in the study eye within 3 months prior to screening
- •5. Aphakia or total absence of the posterior capsule in the study eye
- •6. Known allergy to fluorescein sodium for injection
- •7. Current or planned use of medications known to be toxic to the retina, lens or optic nerve
- •8. Medical history or condition: Uncontrolled diabetes mellitus, with hemoglobin A1c (HbA1c) > 10%, myocardial infarction or stroke within 12 months of screening, active bleeding disorder, concomitant use of warfarin or anticoagulation therapy, major surgery within 1 month of screening or when planned within the study period, hepatic impairment, uncontrolled hypertension
- •9. Planned concomitant use of strong CYP 3A4 or P-gp inhibitors or inducers during the study
- •10. Planned concomitant use of P-gp substrates, that are narrow therapeutic index drugs
- •11. Use of systemic steroids (>10 mg prednisone or equivalent/day) within 14 days of first dose or known diseases which could require the use of systemic steroids within the study period
- •12. Patients with a clinically relevant abnormal screening haematology, blood chemistry, or urinalysis, if the abnormality defines a significant disease as defined in other exclusion criteria. AST or ALT greater than 2.0-fold the upper limit of normal at screening. Patients with total bilirubin TB or INR> 1.5 x upper limit of normal at screening.
- •13. Patient with impaired renal function defined as calculated GFR< 30 mL/min
- •14. Significant alcohol or drug abuse within past 2 years
- •15. Based on central ECG reading, patients with a risk of prolonged QT interval effects
- •16. Significant disease or other medical conditions (as determined by medical history, examination and clinical investigations at screening) that may, in the opinion of the investigator result in the any of the following:
- •Put the patient at risk because of participation in the study,
- •Influence the results of the study,
- •Cause concern regarding the patient’s ability to participate in the study.
研究者
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