2025-520809-12-00招募中3 期
A Randomized, Double-masked, Multi-center, 3-Arm Pivotal Phase 2/3 Study to Evaluate the Efficacy and Safety of Intravitreal EYE103 Compared with Intravitreal ranibizumab (0.5mg) in Participants with Diabetic Macular Edema
Eyebiotech Limited66 个研究点 分布在 9 个国家目标入组 465 人开始时间: 2025年6月24日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 465
- 试验地点
- 66
- 主要终点
- The primary endpoint is defined as the mean change in ETDRS BCVA from Baseline (Day 1) to Year 1 (average of Weeks 48 and 52).
研究概览
简要总结
The primary objective of the study is to demonstrate that EYE103 (0.5 mg or 0.8 mg) is non-inferior to ranibizumab 0.5 mg, as measured by the mean change in BCVA up to and including Week 52. This change will be measured using the standardized ETDRS chart from Day 1 to Year 1 (average of Weeks 48 and 52).
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Participants must be willing and able to understand the study procedures and the risks involved and provide written informed consent before the first study-related activity
- •Be male or female ≥18 years of age.
- •If female, have a negative serum pregnancy test at screening and further negative urine tests immediately before each dose of study medication if the participant is a female of childbearing potential (including those with <2 years since the onset of menopause, amenorrhea for <1 year, or not surgically sterile); such participants must agree to use a highly effective method of contraception from screening up to and including 3 months after the last dose of study drug (see Appendix B). She must also agree not to donate oocytes from screening up to and including 3 months after the last dose of study drug.
- •If male, be surgically sterile for at least 12 weeks, or agree to use an acceptable method of contraception, such as a condom, and a second highly effective method of contraception (see Appendix F) from Screening up to and including 90 days after the last dose of study drug (see Appendix B). He must also agree not to donate sperm from the time of the first dose until 12 weeks after the last dose of study drug.
排除标准
- •Be pregnant or breastfeeding.
- •Have aphakia in the study eye.
- •Have an allergy to fluorescein dye.
- •Have had vitrectomy in the study eye.
- •Have active retinal disease other than the condition (DME/diabetic retinopathy) under investigation in the study eye.
- •Have active or suspected ocular or periocular infection or inflammation in either eye at day
- •Currently have evidence of, or a history of any clinically significant autoimmune, cardiovascular, hematologic, hepatic, metabolic, peripheral vascular, renal, or respiratory disease, which, in the opinion of the investigator, would prevent the participant from completing the required assessments for this study.
- •Have a known hypersensitivity to any of the components of EYE103 formulation or prior hypersensitivity to mAbs.
- •Have had renal failure requiring renal transplant, hemodialysis, or peritoneal dialysis or have renal failure anticipated to require hemodialysis or peritoneal dialysis at any time during the study.
- •Have previously participated in any study of EYE
- •Have uncontrolled blood pressure, defined as systolic ≥180 mmHg and/or diastolic ≥100 mmHg while a participant is at rest If a participant’s initial reading exceeds these values, a second reading may be obtained later the same day or on another day during the screening period. If the participant’s blood pressure is controlled by antihypertensive medication, the participant should be taking the same medication continuously for at least 30 days prior to Day
- •Have history of cataract surgery and/or minimally invasive glaucoma surgery in the study eye within 90 days of screening.
- •Have history of stroke (cerebral vascular accident) or myocardial infarction within 180 days prior to Day
- •Have any active malignancy.
- •Have any history of organ transplant.
- •If treatment-experienced for DME have a history of any of the following treatments within the noted time windows: • Have had prior treatment with 8 mg aflibercept (EYLEA HD) or faricimab (VABYSMO) within 120 days prior to the Screening visit in the study eye • Have had an IVT with other anti-VEGF treatments (ranibizumab, bevacizumab, aflibercept [2 mg], brolucizumab, pegaptanib sodium) in the study eye within 90 days of the Screening visit • Had prior IVT investigational agents in either eye at any time • Had treatment with ocriplasmin (JETREA®) in the study eye at any time • Had previous use of ILUVIEN® at any time, of OZURDEX® IVT implants within 180 days of the Screening visit, or any other intraocular or periocular corticosteroids in the study eye within 90 days of the Screening visit
- •Have any treatment for complications of cataract surgery with steroids or yttrium-aluminum garnet (YAG) laser capsulotomy within 90 days of Screening.
- •Have had pan-retinal photocoagulation or focal/grid thermal laser photocoagulation in the study eye within 90 days of screening.
- •Have any history of retinal detachment or treatment or surgery for retinal detachment in the study eye.
- •Have any history of uveitis in either eye.
- •Have significant media opacities, including cataract, in the study eye that might interfere with VA, assessment of safety, OCT, or fundus photography in the opinion of the reading center.
- •Have been committed to an institution by virtue of an order issued either by the judicial or the administrative authorities.
- •Have a cataract in the study eye that, in the judgment of the investigator is expected to require surgical extraction within 4 months of screening.
结局指标
主要结局
The primary endpoint is defined as the mean change in ETDRS BCVA from Baseline (Day 1) to Year 1 (average of Weeks 48 and 52).
The primary endpoint is defined as the mean change in ETDRS BCVA from Baseline (Day 1) to Year 1 (average of Weeks 48 and 52).
次要结局
未报告次要终点
研究者
Loni Da Silva
Scientific
Eyebiotech Limited
研究点 (66)
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