CTRI/2020/11/028961已完成3 期
A Multi center, Extension Study to Evaluate the Safety and Efficacy of MYL-1701P in Subjects with Diabetic Macular Edema Completed MYL-1701P-3001 Study.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Mylan Inc
- 入组人数
- 70
- 试验地点
- 15
- 主要终点
- Incidence of Treatment emergent adverse events (TEAEs).
研究概览
简要总结
This Extension Study(AFIL-IJZ-3002) is designed to evaluate the safety, efficacy and immunogenicityof MYL-1701P among a group of participants successfully completingMYL-1701P-3001. Subjects participating in this study will receive 3 doses ofMYL-1701P, every 8 weeks. The total study duration will be 24 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
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.Subject participated in the MYL-1701P-3001 study 2.Subject requires treatment with intravitreal anti-VEGF therapy 3.Subject is able to understand and voluntarily provide written informed consent to participate in the study.
- •4.If female of childbearing potential, the subject must have negative pregnancy tests and should not be nursing or planning a pregnancy.
- •5.Subject is willing to comply with the study duration, study visits and study related procedures.
- •6.If female, subject must be: •Surgically sterilized via hysterectomy, bilateral oophorectomy, or bilateral tubal ligation; or •Of childbearing potential and practicing an acceptable form of birth control •Of non-childbearing potential 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.
排除标准
- •1.Subjects with known hypersensitivity to aflibercept or any of the excipients 2.Subjects will be excluded if any of the following conditions are met in the study eye: •Subjects with active ocular inflammation.
- •â€¢Subjects with uncontrolled glaucoma •Surgery for glaucoma in the past or likely to be needed in the future.
- •3.Subjects with active or suspected ocular or periocular infection including but not limited to infectious blepharitis, keratitis, scleritis, or conjunctivitis in either eye.
- •4.Subjects who plan to participate in another clinical study while enrolled in this study.
- •5.Subjects receiving treatment for a serious systemic infection.
- •6.Subjects with uncontrolled hypertension defined as systolic blood pressure > 160 mm Hg or diastolic blood pressure > 95 mm Hg. 7.Subjects with a history of cerebrovascular accident or myocardial infarction within 6 months of enrollment visit.
- •8.Subjects with renal failure requiring dialysis or renal transplant.
- •9.Subjects with a history or presence of any clinically significant condition, that in the opinion of the Investigator would jeopardize the safety of the subject or the validity of the study results.
结局指标
主要结局
Incidence of Treatment emergent adverse events (TEAEs).
时间窗: Week 24
次要结局
- Change from baseline in CRT(Weeks 8, 16 and 20)
- Change from baseline in BCVA(Week 20)
研究者
研究点 (15)
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