CTRI/2019/09/021202已完成3 期
A Multi Center, Randomized, Double-Masked, Active-Controlled, Comparative Clinical Study to Evaluate the Efficacy and Safety of MYL-1701P and Eylea�® in Subjects with Diabetic Macular Edema
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Mylan Inc
- 入组人数
- 77
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Male or female subjects age more than or equal to 18 years.
- •2.Subjects have type 1 or type 2 diabetes mellitus who present with central DME involvement in the study eye.
- •3.The cause of decreased vision in the study eye has been attributed primarily to DME by the Investigator.
- •4.Subject is able to understand and voluntarily provide written informed consent to participate in the study.
- •5.If female of child bearing potential, the subject must have a negative serum pregnancy test at the Screening visit and a negative urine pregnancy test at baseline visit, and should not be nursing or planning a pregnancy.
- •6.If female, subject must be:
- •a.Surgically sterilized via hysterectomy, bilateral oophorectomy, or bilateral tubal ligation; or
- •b.Of childbearing potential and practicing an acceptable form of birth control (defined as the use of an intrauterine device; a barrier method, like condom, with spermicide; any form of hormonal contraceptives; or abstinence from sexual intercourse) starting 60 days prior to dosing and continuing at least 90 days following the last treatment.
- •c.Of non-childbearing potential (i.e., postmenopausal for at least 1year).
- •7.If male, subject must be surgically or biologically sterile. If not sterile, the subject must agree to use an acceptable form of birth control with sexual partner (as described in inclusion criteria #6b of protocol) or abstain from sexual relations during the study period and up to 90 days following the last treatment dose.
- •8.Subject is willing to comply with the study duration, study visits and study related procedures.
排除标准
- •1.Subjects with known hypersensitivity to aflibercept or any of the excipients
- •2.Subjects with current or planned use of systemic medications known to be toxic to the lens, retina or optic nerve, including deferoxamine, chloroquine/hydroxychloroquine, tamoxifen, phenothiazines and ethambutol
- •3.Subjects with uncontrolled hypertension defined as systolic blood pressure >160mm Hg or diastolic blood pressure > 95 mm of Hg.
- •4.Subjects with a history of cerebrovascular accident or myocardial infarction within 6 months of randomization.
- •5.Subjects with a clinical diagnosis of glaucoma (controlled or uncontrolled)
- •6.Subjects who have only one functional eye, even if the eye met all other study requirements, or who have an ocular condition on the fellow eye with a poorer prognosis than the study eye.
研究者
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