EUCTR2015-001961-20-CZ进行中（未招募）1 期
Efficacy and safety of the biosimilar ranibizumab FYB201 in comparison to Lucentis in patients with neovascular age-related macular degeneration (COLUMBUS-AMD)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Bioeq GmbH
- 入组人数
- 500
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. Age = 50 years of either gender
- •2. Signed informed consent form must be obtained before any study-related procedure is performed
- •3. Willingness and ability to undertake all scheduled visits and assessments
- •4. Women must be postmenopausal or surgically sterile
- •5. Newly diagnosed, angiographically documented, primary active CNV lesion secondary to age-related macular degeneration (AMD)
- •6. Sufficiently clear ocular media and adequate pupillary dilation to permit good quality ocular imaging
- •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 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 400
排除标准
- •1. Any prior treatment with IVT anti-vascular endothelial growth factor (VEGF) agent (e.g., bevacizumab, aflibercept, ranibizumab) in either eye
- •2. History of vitrectomy, macular surgery or other surgical intervention for AMD in the study eye
- •3. History of IVT or periocular injections of corticosteroids or device implantation within six months prior to Screening in the study eye
- •4. Prior treatment with verteporfin (photodynamic therapy), transpupillary thermotherapy, radiation therapy, or retinal laser treatment (e.g. focal laser photocoagulation) in the study eye
- •5. Topical ocular corticosteroids administered for at least 30 consecutive days within three months prior to Screening
- •6. Any other intraocular surgery (including cataract surgery) in the study eye within three months prior to Screening
- •7. Sub- or intra-retinal hemorrhage that comprises more than 50% of the entire lesion in the study eye
- •8. Fibrosis or atrophy involving the center of the fovea or influencing central visual function in the study eye
- •9. CNV in either eye due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia
- •10. Retinal pigment epithelial tear involving the macula in the study eye
- •11. History of full-thickness macular hole (stage 2 and above by clinical examination or full thickness macular hole by SD-OCT imaging of any size) in the study eye
- •12. History of retinal detachment in the study eye
- •13. Current vitreous hemorrhage in the study eye
- •14. Spherical equivalent of the refractive error in the study eye demonstrating more than 8 diopters of myopia
- •15. For patients who have undergone prior refractive or cataract surgery in the study eye, the preoperative refractive error in the study eye cannot exceed 8 diopters of myopia
- •16. History of corneal transplant in the study eye
- •17. Aphakia in the study eye. Absence of an intact posterior capsule is allowed if it occurred as a result of YAG laser posterior capsulotomy in association with prior posterior chamber intraocular lens (IOL) implantation
- •18. Active or recent (within 4 weeks) intraocular inflammation of clinical significance in the study eye such as active infections of the anterior segment (excluding mild blepharitis) including conjunctivitis, keratitis, scleritis, uveitis or endophthalmitis
- •19. Uncontrolled hypertension or glaucoma in the study eye (defined as intraocular pressure [IOP] =30 mm Hg, despite treatment with anti-glaucomatous medication)
研究者
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