A Phase 3 Trial for Intravitreal Injection of 4D-150 in Adults With Diabetic Macular Edema (DME). (4SIGHT)
A Phase 3, Randomized, Double-Masked, Active-Controlled Trial to Evaluate the Efficacy, Safety, and Durability of a Single Intravitreal Injection of 4D-150 Versus Aflibercept in Adults With Diabetic Macular Edema (4SIGHT)
A Phase 3, Randomized, Double-Masked, Active-Controlled Trial to Evaluate the Safety, Efficacy, and Durability of a Single Intravitreal Injection of 4D-150 versus Aflibercept in Adults with Diabetic Macular Edema (4SIGHT)
研究概览
地位
研究类型
注册 (估计的)
阶段
- 第三阶段
联系人和位置
学习联系方式
- 姓名：4DMT Patient Advocacy
- 电话号码：(888) 748-8881
- 邮箱：clinicaltrials@4DMT.com
研究联系人备份
- 姓名：4SIGHT Medical Monitoring Distribution List
- 邮箱：4D150C005_MM@4dmt.com
学习地点
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Beijing、中国、100730
- 尚未招聘
- Beijing Tongren Hospital
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Changchun、中国、130041
- 尚未招聘
- The Second Hospital of Jilin University
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Changsha、中国、410300
- 尚未招聘
- The Second Xiangya Hospital of Central South University
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Haerbin、中国、150001
- 尚未招聘
- The Second Affiliated Hospital of Harbin Medical University
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Hangzhou、中国、310015
- 尚未招聘
- Zhejiang Provincial People's Hospital
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Jinan、中国、250021
- 尚未招聘
- Eye Hospital of Shandong First Medical University
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Jinan、中国、450006
- 尚未招聘
- Zhengzhou Second Peoples Hospital
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Lanzhou、中国、730030
- 尚未招聘
- Lanzhou University Second Hospital
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Nanchang、中国、330006
- 尚未招聘
- Nanchang University Affiliated Eye Hospital
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Shanghai、中国、200080
- 尚未招聘
- Shanghai First People's Hospital
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Shanghai、中国、200031
- 尚未招聘
- Fudan University - Eye & ENT Hospital
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Taiyuan、中国、030032
- 尚未招聘
- Shanxi Academy of Medical Sciences - Shanxi Bethune Hospital
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Taizhou、中国、317000
- 尚未招聘
- Taizhou Hospital of Zhejiang Province
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Tianjin、中国、300384
- 尚未招聘
- Tianjin Medical University Eye Hospital
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Weifang、中国、261021
- 尚未招聘
- Weifang Eye Hospital
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Wuhan、中国、430014
- 尚未招聘
- Huazhong University of Science and Technology-Tongji Medical College-The Central Hospital of Wuhan
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Wuhan、中国、430060
- 尚未招聘
- Wuhan University Renmin Hospital (Hubei General Hospital)
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Zhengzhou、中国、450003
- 尚未招聘
- Henan Eye Hospital, Henan Provincial People's Hospital
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-
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Amagasaki-shi、日本、660-8550
- 尚未招聘
- Hyogo Prefectural Amagasaki General Medical Center (Hyogo AGMC)
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Fukuoka、日本、812-8582
- 尚未招聘
- Kyushu University Hospital
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Fukuoka、日本、812-0011
- 尚未招聘
- Hayashi Eye Hospital
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Fukushima、日本、960-1295
- 尚未招聘
- Fukushima Medical University Hospital
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Hachioji-shi、日本、193-0998
- 尚未招聘
- Tokyo Medical University Hachioji Medical Center
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Kagoshima、日本、890-8520
- 尚未招聘
- Kagoshima University Hospital
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Kita-Gun、日本、761-0793
- 尚未招聘
- Kagawa University Hospital
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Kobe、日本、650-0047
- 尚未招聘
- Kobe City Eye Hospital
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Kyoto、日本、606-8507
- 尚未招聘
- Kyoto University Hospital
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Mitaka-shi、日本、181-8611
- 尚未招聘
- Kyorin University - Kyorin University Hospital - Mitaka
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Miyazaki、日本、889-1692
- 尚未招聘
- University of Miyazaki Hospital
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Nagoya、日本、466-8560
- 尚未招聘
- Nagoya University Hospital
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Sakura-shi、日本、285-8741
- 尚未招聘
- Toho University Sakura Medical Center
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Tokyo、日本、152-8902
- 尚未招聘
- National Hospital Organization Tokyo Medical Center
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Tokyo、日本、113-8431
- 尚未招聘
- Juntendo University Hospital
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Ibaraki
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Mito、Ibaraki、日本、310-0845
- 尚未招聘
- Kozawa Eye Hospital and Diabetes Center
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Arecibo、波多黎各、00612
- 尚未招聘
- Emanuelli Research & Development Center, LLC (ERD)
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Arizona
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Scottsdale、Arizona、美国、85255
- 招聘中
- Research Network Arizona
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California
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Encino、California、美国、91436
- 招聘中
- The Retina Partners
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Fullerton、California、美国、92835
- 尚未招聘
- Retina Consultants of Orange County
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Huntington Beach、California、美国、90266
- 尚未招聘
- Retina Associates of Southern California
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Sacramento、California、美国、95825
- 尚未招聘
- Retinal Consultants Medical Group Inc.
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San Diego、California、美国、92064
- 尚未招聘
- Retina Consultants San Diego
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San Mateo、California、美国、94401
- 尚未招聘
- Retina Institute of New England
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Walnut Creek、California、美国、94598
- 尚未招聘
- Bay Area Retina Associates - Walnut Creek
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Colorado
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Aurora、Colorado、美国、80012
- 招聘中
- Retina Specialists of Colorado - Aurora
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Colorado Springs、Colorado、美国、80909
- 尚未招聘
- Retina Consultants of Southern Colorado P.C.
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Durango、Colorado、美国、81303
- 招聘中
- Southwest Retina Consultants
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Connecticut
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Greenwich、Connecticut、美国、06830
- 招聘中
- Coastal Eye- Greenwich
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Waterford、Connecticut、美国、06385
- 尚未招聘
- Retina Institute of New England, PC
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Florida
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Fort Lauderdale、Florida、美国、33308
- 尚未招聘
- Retina Group of Florida
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Orlando、Florida、美国、32806
- 尚未招聘
- Florida Retina Institute
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Pensacola、Florida、美国、32503
- 招聘中
- Retinal Specialty Institute
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Plantation、Florida、美国、33324
- 尚未招聘
- Fort Lauderdale Eye Institute (FLEI)-Plantation
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Tampa、Florida、美国、33607
- 招聘中
- Retina Vitreous Associates of Florida
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Illinois
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Elmhurst、Illinois、美国、60126
- 招聘中
- Retina Associates, Ltd.
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Lemont、Illinois、美国、60439
- 招聘中
- University Retina and Macula Associates, PC - Lemont
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Oak Park、Illinois、美国、60304
- 尚未招聘
- Illinois Retina Associates
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Springfield、Illinois、美国、62703
- 尚未招聘
- Springfield Clinic
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Indiana
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Carmel、Indiana、美国、46032
- 尚未招聘
- Midwest Eye Institute
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Maryland
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Chevy Chase、Maryland、美国、20815
- 尚未招聘
- The Retina Group of Washington
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Hagerstown、Maryland、美国、21740
- 尚未招聘
- Cumberland Valley Retina Consultants
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Hagerstown、Maryland、美国、21740
- 尚未招聘
- Mid Atlantic Retina Specialist
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Mississippi
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Madison、Mississippi、美国、39110
- 尚未招聘
- Mississippi Retina Associates
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Southaven、Mississippi、美国、38671
- 招聘中
- Deep Blue Retina Clinical Research, PLLC
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Missouri
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St Louis、Missouri、美国、63128
- 尚未招聘
- The Retina Institute
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Nevada
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Reno、Nevada、美国、89502
- 招聘中
- Sierra Eye Associates
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New Jersey
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Bloomfield、New Jersey、美国、07003
- 招聘中
- Envision Ocular, LLC
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Edison、New Jersey、美国、08820
- 尚未招聘
- NJ Retina
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New York
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New York、New York、美国、10017
- 尚未招聘
- NYU Langone Health
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New York、New York、美国、13088
- 招聘中
- Retina Vitreous Surgeons of CNY, PC
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Westbury、New York、美国、11590
- 尚未招聘
- Vitreoretinal Consultants of New York (VRCNY)
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North Carolina
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Asheville、North Carolina、美国、28803
- 招聘中
- Asheville Eye Associates - Retina Division
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Cary、North Carolina、美国、27511
- 尚未招聘
- North Carolina Retina Associates - Cary Office
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Wake Forest、North Carolina、美国、27587
- 尚未招聘
- North Carolina Retina Associates- Wake Forest
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Ohio
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Middleburg Heights、Ohio、美国、44130
- 尚未招聘
- Retina Associates of Cleveland
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Oklahoma
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Edmund、Oklahoma、美国、73013
- 招聘中
- Retina Vitreous Center
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Oregon
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Portland、Oregon、美国、97233
- 尚未招聘
- EyeHealth Northwest
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Pennsylvania
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Bethlehem、Pennsylvania、美国、18017
- 撤销
- Mid Atlantic Retina
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Philadelphia、Pennsylvania、美国、19107
- 尚未招聘
- Mid Atlantic Retina - Philadelphia
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South Dakota
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Rapid City、South Dakota、美国、57701
- 招聘中
- Black Hills Regional Eye Institute
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Tennessee
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Nashville、Tennessee、美国、37203
- 尚未招聘
- Tennessee Retina
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Texas
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Abilene、Texas、美国、79606
- 尚未招聘
- West Texas Retina Consultants
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Austin、Texas、美国、78750
- 招聘中
- Austin Clinical Research
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Austin、Texas、美国、78705
- 尚未招聘
- Austin Retina Associates
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Austin、Texas、美国、78705
- 尚未招聘
- Austin Research Center for Retina
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Dallas、Texas、美国、75231
- 招聘中
- Texas Retina Associate
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Houston、Texas、美国、77030
- 招聘中
- Texas Retina Center
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Katy、Texas、美国、77494
- 尚未招聘
- Retina Consultants of Texas - Katy
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The Woodlands、Texas、美国、77384
- 尚未招聘
- Retina Consultants of Texas
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Tyler、Texas、美国、75703
- 招聘中
- Tyler Retina Consultants
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Virginia
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Fairfax、Virginia、美国、22031
- 招聘中
- The Retina Group of Washington
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Lynchburg、Virginia、美国、24502
- 招聘中
- Piedmont Eye Center
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Wisconsin
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Wausau、Wisconsin、美国、55403
- 尚未招聘
- Eye Clinic of Wisconsin
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
5.2 Inclusion Criteria
Individuals eligible to participate in the trial must meet the following inclusion criteria:
General Inclusion Criteria
- Signed informed consent before any protocol-specified assessment is performed
- Ability and willingness to comply with the protocol-specified procedures (including IVT injection) and visits, in the Investigator's judgment
- ≥18 years of age at time of signing informed consent
- Documented diagnosis of diabetes mellitus (Type 1 or Type 2)
- WOCBP must agree to use highly effective contraception from the time of informed consent, through duration of trial participation
- Agree to use a barrier method (e.g., condom) during intercourse for 3 months after Day 1 to prevent fluid transmission; sexually active males should not father a child or donate sperm during this period Ocular Inclusion Criteria
- Macular thickening secondary to DME involving the center of the fovea (confirmed by the Reading Center) in the study eye
- Study eye amenable to IVT injection identified
- Presence of intraretinal fluid and/or subretinal fluid secondary to DME
- Decreased visual acuity attributable primarily to DME, as determined by the Investigator
- Demonstrated clinical response to aflibercept and functional stability in the study eye
Exclusion Criteria: Individuals who meet any of the following exclusion criteria will not be eligible to participate:
Ocular Condition
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Macular conditions other than DME
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History or presence of moderate Proliferative Diabetic Retinopathy or worse
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History of retinal detachment in the study eye
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History or presence of active inflammation or infection in either eye
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History or presence of low Intraocular Pressure
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Uncontrolled glaucoma or intraocular hypertension
Ocular Treatments/Interventions:
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Any prior concomitant treatment for DME
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History of prior significant ocular surgery or treatment
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Any prior investigational drug, agent, device, or gene therapy
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：4D-150 IVT (3x10^10 vg/eye)
|
If randomized to the 4D-150 treatment arm, 4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1 |
|
有源比较器：Active Comparator (AFLB) 2mg IVT
|
EYLEA ® (aflibercept) will be administered at applicable visits |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Mean change from baseline in Early Treatment Diabetic Retinopathy Study best-corrected visual acuity letter score at Week 52
大体时间：52 weeks
|
The minimum and maximum values are: 0 to 100 The higher the value the better the result |
52 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Mean annualized number of aflibercept injections after Week 4 through Week 52
大体时间：Week 4 through Week 52
|
Minimum 0 maximum 12 One injection per visit, one visit every four weeks |
Week 4 through Week 52
|
|
Proportion of participants with a ≥ 2-step improvement from baseline in Early Treatment Diabetic Retinopathy Study Diabetic Retinopathy Severity Scale (ETDRS-DRSS) at Week 52
大体时间：52 weeks
|
ETDRS-DRSS is a visual acuity test Results are analyzing using a generalized estimating equations model |
52 weeks
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 4D-150-C005
- 4SIGHT (其他标识符：Sponsor)
- 4D-150-C005 (其他标识符：Sponsor)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
Data obtained through this study may be provided, after deidentification, to qualified researchers with academic interest in DME in compliance with ICMJE policy. Data or samples shared will be coded, with no Protected Health Information included. Additionally, descriptions of the study protocol, Statistical Analysis Plan (SAP), informed consent and clinical study report may be shared publicly. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party. Data requests can be submitted starting after final Clinical Study Report and the data will be made accessible for a duration determined by the Sponsor, and in accordance with ICMJE policy. Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and SAP and execution of a Data Sharing Agreement (DSA)
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.