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 (DME)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 355
- 试验地点
- 3
- 主要终点
- Mean Change From Baseline in Best Corrected Visual Acuity (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 to be randomized 1:1 to intravitreal treatment with MYL-1701P or Eylea®.
The primary endpoint is mean change from baseline in Best Corrected Visual Acuity (BCVA) as assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) letters. Pharmacokinetics (PK) and immunogenicity to be evaluated in the subjects participating in the study.
详细描述
Three hundred and twenty-four (324) eligible adult subjects with diabetes mellitus with central DME involvement to be randomized 1:1 to intravitreal treatment with MYL-1701P or Eylea®. Subjects to receive the assigned treatment until Week 48.
All subjects to return to clinic every 4 weeks to assess safety, efficacy and to guide treatment. Additional visits allowed during the study as specified in the study schedule for safety and pharmacokinetic evaluation.
Pharmacokinetics (PK) and Immunogenicity to be assessed in the subjects participating in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Masked study drug kits will be supplied to sites as necessary during the study. The outside label of the box will not reveal the identity of the product inside (whether it is Eylea or MYL-1701P) and will be assigned in a masked fashion through the Interactive Response Technology (IRT) system. An un-masked team will identified at site, to be responsible for preparation and administration of the study drug.
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
- •Male or female subjects age ≥ 18 years.
- •Subjects have type 1 or type 2 diabetes mellitus who present with central DME involvement in the study eye.
- •The cause of decreased vision in the study eye has been attributed primarily to DME by the Investigator.
- •Subject is able to understand and voluntarily provide written informed consent to participate in the study.
- •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.
- •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 (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.
- •Of non-childbearing potential (i.e., postmenopausal for at least 1 year).
- •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.
- •Subject is willing to comply with the study duration, study visits and study related procedures.
排除标准
- •Subjects with known hypersensitivity to aflibercept or any of the excipients
- •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
- •Subjects with uncontrolled hypertension defined as systolic blood pressure >160mm Hg or diastolic blood pressure > 95 mm of Hg.
- •Subjects with a history of cerebrovascular accident or myocardial infarction within 6 months of randomization.
- •Subjects with history of use of intraocular corticosteroids anytime in the past or periocular (subconjunctival, intra-scleral, sub-tenon or retrobulbar) corticosteroids within 4 months of randomization
- •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.
研究组 & 干预措施
MYL-1701P
MYL-1701P
干预措施: MYL-1701P (Drug)
Eylea
Eylea
干预措施: Eylea (Drug)
结局指标
主要结局
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Week 8
时间窗: Baseline and 8 weeks
Mean change from baseline in BCVA as assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) letters at week 8. Best Corrected Visual Acuity (BCVA) is measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the ETDRS chart, the worse the vision (or visual acuity). A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening.
次要结局
- The Mean Change From Baseline in Central Retinal Thickness (CRT)(From baseline to week 52)
- Concentration of Aflibercept in Blood (Pharmacokinetics)(2 Days after Week 16 Injection)
- The Mean Change in BCVA(From baseline to week 52)
- Number of Subjects Who Gained ≥15 Letters From Baseline in BCVA(From baseline to week 52)
- Number of Administrations of Study Drug Required(From baseline to week 52)
- Number of Participants With Treatment Emergent Adverse Events(From baseline to week 52)
- Number of Subjects With Induced and Boosted Anti-Drug Antibodies(From baseline to week 52)