EUCTR2008-008200-40-AT进行中（未招募）不适用
A Double-Masked, Randomized, Controlled Study of the Safety, Tolerability andBiological Effect of Repeated Intravitreal Administration of VEGF Trap-Eye inPatients with Diabetic Macular Edema (DME) - DAVINCI
Regeneron Pharmaceuticals, Inc0 个研究点目标入组 200 人开始时间: 2009年4月3日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
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. Patients with clinically significant DME with central involvement defined as OCT central subfield thickness = 250 µm.
- •2. Adults = 18 years with type 1 or 2 diabetes mellitus with diabetic macular edema
- •3. ETDRS BCVA: 20/40 to 20/320 (letter score of 73 to 24) in the study eye
- •4. For men and women of childbearing potential, willingness to utilize adequate contraception and not become pregnant (or have their partner[s] become pregnant) during the full course of the study. Adequate contraceptive measures include oral contraceptives (stable use for 2 or more cycles prior to screening) and other prescription pharmaceutical contraceptives; IUD; bilateral tubal ligation; vasectomy; condom or diaphragm plus either contraceptive sponge, foam or jelly.
- •5. Willing, committed, and able to return for ALL clinic visits and complete all study-related procedures.
- •6. Willingness to provide written informed consent and, at U.S. sites, Health Insurance Portability and Accountability Act (HIPAA) authorization and in other countries, as applicable according to national laws
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. History of vitreoretinal surgery in the study eye
- •2. Panretinal laser photocoagulation or macular laser photocoagulation in the study eye within 3 months of Screening
- •3. Vision decrease due to causes other than diabetic macular edema
- •4. Previous use of intraocular or periocular corticosteroids in the study eye within3 months of Screening
- •5. Previous treatment with anti-angiogenic drugs in either eye (pegaptanib sodium, anecortave acetate, bevacizumab, ranibizumab, etc.) within 3 months of Screening
- •6. Proliferative Diabetic Retinopathy (PDR) in the study eye, with the exception of inactive, regressed PDR
- •7. Iris neovascularization, vitreous hemorrhage, traction retinal detachment, or preretinal fibrosis involving the macula in either eye
- •8. Vitreomacular traction or epiretinal membrane in either eye evident biomicroscopically or on OCT that is considered by the investigator to significantly affect central vision
- •9. Ocular inflammation (including trace or above) in the study eye
- •10. History of idiopathic or autoimmune uveitis in either eye
- •11. Structural damage to the center of the macula in either eye that is likely to preclude improvement in VA following the resolution of macular edema
- •12. Concurrent disease in the study eye that would compromise VA or require medical or surgical intervention during the study period
- •13. Cataract surgery in the study eye within 3 months, yttrium-aluminum-garnet (YAG) laser capsulotomy within the past 2 months, or any other intraocular surgery within the 90 days preceding Screening
- •14. Aphakia or absence of the posterior capsule in the study eye
- •15. Uncontrolled glaucoma or previous filtration surgery in either eye. Uncontrolled glaucoma is defined as intraocular pressure greater than or equal to 25 mm Hg on an optimal medical regimen
- •16. Spherical equivalent of the refractive error in the study eye of more than - 8 diopters myopia (for subjects who have had refractive or cataract surgery in the study eye, preoperative spherical equivalent refractive error of more than - 8 diopters myopia)
- •17. Evidence at examination of infectious blepharitis, keratitis, scleritis, or conjunctivitis in either eye or current treatment for serious systemic infection
- •18. Any ocular disorders in the study eye that, in the opinion of the Investigator, may confound interpretation of study results
- •19. Uncontrolled diabetes mellitus
- •20. Uncontrolled hypertension defined as systolic > 180 mmHg or > 160 mmHg on 2 consecutive measurements or diastolic > 100 mmHg on optimal medical regimen
- •21. History of cerebral vascular accident or myocardial infarction within 6 months prior to Day 1
- •22. Renal failure requiring dialysis or renal transplant
- •23. Participation in an investigational study within 30 days prior to Screening that involved treatment with any drug (excluding vitamins and minerals) or device
- •24. History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use an investigational drug, might affect interpretation of the results of the study, or renders the subject at high risk from treatment complications
- •25. Pregnancy or lactation
- •26. History of allergy to fluorescein
- •27. History of allergy to povidone iodine
- •28. Inability to obtain fundus photographs or fluorescein angiograms of sufficientquality to be analyzed by the site
- •29. Only one functional eye even if the eye is otherwise eligible for th
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