EUCTR2015-001961-20-ES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
- 650
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 (? 12 months of non-therapy-induced amenorrhea) or surgically sterile (with documentation in the patient?s medical records)
- •5. Newly diagnosed, angiographically documented, primary active CNV lesion secondary to age-related macular degeneration (AMD)
- •a. All subtypes of wet AMD CNV lesions are eligible (classic, occult, some classical component, retinal angiomatous proliferation lesions). Active primary CNV must be subfoveal or juxtafoveal with subfoveal component related to CNV activity (such as sub- or intraretinal fluid by spectral domain optical coherence tomography (SD-OCT) or retinal pigment epithelium (RPE) detachment)
- •b. Total area of whole lesion must be equal or less than 12 disc areas
- •c. Total CNV area encompasses equal or more than 50% of total lesion area based on fluorescein angiography (FA), including all subtypes of wet AMD
- •6. Sufficiently clear ocular media and adequate pupillary dilation to permit good quality ocular imaging
- •7. BCVA in the study eye, determined by standardized Early Treatment Diabetic Retinopathy Study (ETDRS) testing, between 20/32 (0.63) and 20/100 (0.2) Snellen equivalent
- •8. FCP retinal thickness at Screening ? 350 µm. (FCP thickness is defined as the distance between the vitreoretinal interface and Bruch?s membrane at the geometric center of the fovea)
- •9. BCVA in the fellow eye, determined by standardized ETDRS testing, at least 20/100 (0.2) Snellen equivalent
- •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 250
- •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 previous 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 treatment with 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)
- •20. Ocular disorders in the study eye (i.e. retinal detachment, pre-retinal membrane of the macula or cataract with significant impact on visual acuity) at the time of enrollment that may confound interpretation of study results and compromise visual acuity
- •21. Any concurrent intraocular condition in the study eye (e.g. glaucoma, cataract or diabetic retinopathy) that, in the opinion of the Investigator, would either require surgical intervention during the study to prevent or treat visual loss that might result from that condition or affect interpretation of study results.
- •22. Use of other investigational drugs (excluding vitamins, minerals) within 30 days or 5 half-lives from Screening, whichever is longer
- •23. Any type of advanced, severe or unstable disease, including any medical condition (controlled or uncontrolled) that could be expected to progress, recur, or change to such an extent that it may bias the assessment of the clinical status of the patient to a significant degree or put the patient at special risk
- •24. Stroke or myocardial infa
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