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
- 356
- 试验地点
- 17
- 主要终点
- Primary Endpoints: The mean change from baseline in BCVA at week 8
研究概览
简要总结
Three hundred and twenty-four (324) eligible adult subjects with diabetes mellitus with central DME involvement will be randomized 1:1 to intravitreal treatment with MYL-1701P or Eylea®. Subjects will receive the assigned treatment until Week 48.
All subjects will return to clinic every 4 weeks to assess safety, efficacy and to guide treatment. There will be additional visits during the study as specified in the study schedule for safety and pharmacokinetic evaluation.
Pharmacokinetics (PK) and Immunogenicity will be assessed in the subjects participating in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
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.
- •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).
- •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.
结局指标
主要结局
Primary Endpoints: The mean change from baseline in BCVA at week 8
时间窗: 8 week
次要结局
- Secondary Endpoints(1.The mean change from baseline in CRT over time)
研究者
研究点 (17)
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