EUCTR2012-003763-22-SK进行中（未招募）1 期
A combined Phase IIa / IIb study of the efficacy, safety, and tolerability of repeated topical doses of regorafenib eye drops, in treatment-naïve subjects with neovascular age related macular degeneration - Regorafenib eye drops: Investigation of efficacy and safety in wet AMD
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
- 540
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
- •2. Signed informed consent
- •3. Men and women = 50 years of age
- •4. Active primary subfoveal choroidal neovascularization lesions secondary to age related macular degeneration, including juxtafoveal lesions that affect the fovea as evidenced by fluorescein angiography in the study eye and reviewed by the central reading center
- •5. The area of choroidal neovascularization must occupy at least 50% of total lesion in the study eye, as determined by fluorescein angiography review at the central reading center
- •6. Evidence of intraretinal and/or subretinal fluid on OCT and reviewed by the central reading center
- •7. Early Treatment Diabetic Retinopathy Study best corrected visual acuity of 73 to 25 letters (20/40 to 20/320 Snellen equivalent) in the study eye
- •8. Willing, committed, and able to return for all clinic visits and complete all study related procedures Subjects who participate in Part A of the protocol are ineligible for Part B.
- •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 95
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 445
排除标准
- •1.Concurrent disease in the study eye, other than AMD (e.g., corneal diseases and dystrophies, conjunctival diseases, eye lid abnormalities, or any other diseases of the cornea and macula, or optic nerve abnormality) that could compromise visual acuity, likely require medical or surgical intervention during the study period, would limit the potential to gain or lose vision during study treatment, or could otherwise confound interpretation of the results
- •2.Any findings in the study eye that would limit the potential to benefit from study treatment, or could otherwise confound interpretation of the results such as total lesion size (including structural damage to the center of macula, neovascularization, scar, blood) >12 disc areas (30.5 mm2) and subfoveal fibrosis as assessed by FA
- •3.Only one functional eye, even if that eye is otherwise eligible for the study
- •4.Prior ocular or systemic treatment or surgery for neovascular AMD in the study eye except dietary supplements or vitamins
- •5.Prior treatment with any systemic anti-VEGF agent 6.Use of systemic or ocular treatment with an investigational drug within 12 weeks prior to start of study treatment
- •12.History or current use of long-acting steroids, either systemically or injected intraocularly, periocularly, subconjunctivally
- •15. Intraocular pressure = 25 millimeters of mercury (mmHg) in the study eye as well as uncontrolled glaucoma
- •16. Any other condition that would require frequent chronic co-administration of other topical eye medications that would interfere with study drug administration
- •17. Symptoms or conditions consistent with contraindications listed in the current local label for ranibizumab
- •18. Participation in an investigational study within 30 days prior to start of study treatment that involved treatment with any drug (excluding vitamins and minerals) or device
- •27.Lactating women and women of child-bearing potential with either a positive pregnancy test result or no pregnancy test at s are excluded. Postmenopausal women must be amenorrheic for at least 12 months in order not to be considered of child bearing potential. For more please refer to protocol.
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