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
- 入组人数
- 52
- 试验地点
- 17
- 主要终点
- Incidence of Treatment emergent adverse events (TEAEs).
研究概览
简要总结
This Study (AFIL-IJZ-3002) is designed to evaluate the safety, efficacy and immunogenicity of MYL-1701P among a group of participants successfully completing MYL-1701P-3001 (NCT03610646) study.
详细描述
Diabetic retinopathy is an important cause of blindness worldwide. The International Diabetes Federation estimates that 285 million people worldwide have diabetes mellitus and approximately 7% of these individuals are affected by diabetic macular edema.
EYLEA® (aflibercept) injection, an anti-Vascular Endothelial Growth Factor (VEGF) agent, has been approved by the FDA and EMA for the treatment of Diabetic Macular Edema (DME).
Mylan Inc. and Momenta Pharmaceuticals, Inc. are developing MYL-1701P, a proposed biosimilar to Eylea.
MYL-1701P-3001 (NCT03610646) study was designed to evaluate the efficacy, safety, pharmacokinetics, and immunogenicity of MYL-1701P in the treatment of subjects with Diabetic Macular Edema (DME). Eligible subjects from MYL-1701P-3001 (NCT03610646) study will be enrolled in the AFIL-IJZ-3002 study. All enrolled subjects will receive three doses of MYL-1701P every eight weeks. Subjects will attend the clinic visits for safety and efficacy assessments including Best Corrected Visual Acuity (BCVA), Spectral domain- Optical Coherence Tomography (SD-OCT), complete ophthalmological examinations during the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject participated in the MYL-1701P-3001 study
- •Subject requires treatment with intravitreal anti-VEGF therapy
- •Subject is able to understand and voluntarily provide written informed consent to participate in the study.
- •If female of childbearing potential, the subject must have negative pregnancy tests and should not be nursing or planning a pregnancy.
- •Subject is willing to comply with the study duration, study visits and study related procedures.
- •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
- •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
- •Subjects with known hypersensitivity to aflibercept or any of the excipients
- •Subjects will be excluded if any of the following conditions are met in the study eye:
- •Subjects with active ocular inflammation.
- •Subjects with uncontrolled glaucoma
- •Surgery for glaucoma in the past or likely to be needed in the future.
- •Subjects with active or suspected ocular or periocular infection including but not limited to infectious blepharitis, keratitis, scleritis, or conjunctivitis in either eye.
- •Subjects who plan to participate in another clinical study while enrolled in this study.
- •Subjects receiving treatment for a serious systemic infection.
- •Subjects with uncontrolled hypertension defined as systolic blood pressure > 160 mm Hg or diastolic blood pressure > 95 mm Hg.
- •Subjects with a history of cerebrovascular accident or myocardial infarction within 6 months of enrollment.
- •Subjects with renal failure requiring dialysis or renal transplant.
- •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.
研究组 & 干预措施
Single, test arm
Open label, single arm study
干预措施: MYL-1701P, a proposed biosimilar to Eylea (Biological)
结局指标
主要结局
Incidence of Treatment emergent adverse events (TEAEs).
时间窗: Week 20
Number of participants with TEAEs
Incidence of Treatment Emergent Adverse Events (TEAEs).
时间窗: Week 20
Incidence of treatment-emergent adverse events was defined as the number and percentage of participants experiencing at least one TEAE during the study period. Incidence is reported as categorical participant counts rather than person-time-based rates due to the fixed study duration.
次要结局
- Change from baseline in BCVA(Weeks 8, 16 and 20)
- Change from baseline in CRT(Weeks 8, 16 and 20)
- Change From Baseline in CRT at Week 16(Week 16)
- Change From Baseline in BCVA at Week 8(Week 8)
- Change From Baseline in CRT at Week 8(Weeks 8)
- Change From Baseline in BCVA at Week 16(Week 16)
- Change From Baseline in BCVA at Week 20(Week 20)
- Change From Baseline in CRT at Week 20(Week 20)