Pegaptanib Sodium Compared to Sham Injection in Patients With Recent Vision Loss Due to Macular Edema Secondary to Central Retinal Vein Occlusion (CRVO)
A Phase II Randomized, Dose-Ranging, Double-Masked, Multi-Center Trial, in Parallel Groups, Determining Safety, Efficacy and PK of Intravitreous Injections of Pegaptanib Sodium Compared to Sham Injection for 30 Weeks in Patients With Recent Vision Loss Due to Macular Edema Secondary to CRVO
Eyetech Pharmaceuticals Inc. and Pfizer, Inc. are studying an investigational drug, MacugenTM, for the possible treatment of CRVO. An investigational drug is one that has not been approved by the U.S. Food and Drug Administration (FDA). This investigational drug may slow the growth of abnormal blood vessels in the eye and may reduce tissue swelling in the eye.
The purpose of this study is to compare the safety and efficacy of a Macugen™ injection to a "pretend" injection. In addition, the purpose of this study is to measure the action of the study drug in the body over a period of time and to check for the presence of the study drug in your blood (called pharmacokinetics or PK).
This study will involve approximately 90 people. People who decide to participate will have an equal chance (1 in 3) to receive one of three study injections, two of which are Macugen™ and one of which is a "pretend" injection.
研究概览
详细说明
研究类型
注册
阶段
- 阶段2
联系人和位置
学习地点
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Arizona
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Tucson、Arizona、美国、85704
- Retina Centers, P.C., Northwest Location
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Tucson、Arizona、美国、85710
- Retina Associates, SW
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California
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Los Angeles、California、美国、90095
- Jules Stein Institute
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Santa Ana、California、美国、92705
- Orange County Retina Associates
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Connecticut
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Hamden、Connecticut、美国、06518
- New England Retina Associates
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Florida
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Fort Lauderdale、Florida、美国、33334
- Retina Group of Florida
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Miami、Florida、美国、33136
- Bascom Palmer Eye Institute
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Illinois
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Chicago、Illinois、美国、60637
- The University of Chicago
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Indiana
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Indianapolis、Indiana、美国、46280
- Macula-Retina-Vitreous Service
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Kansas
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Wichita、Kansas、美国、67214
- Vitreo-Retinal Consultants & Surgeons, P.A.
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Louisiana
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New Orleans、Louisiana、美国、70155
- Retina Associates
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Maryland
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Chevy Chase、Maryland、美国、20815
- Retina Group of Washington
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Hagerstown、Maryland、美国、21740
- Cumberland Valley Retina Center
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Massachusetts
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Boston、Massachusetts、美国、02114
- Massachusetts Eye & Ear Infirmary
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Boston、Massachusetts、美国、02111
- New England Eye Center
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Peabody、Massachusetts、美国、01960
- Lahey Clinic, The Eye Institute
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Michigan
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Detroit、Michigan、美国、48201
- Kresge Eye Institute
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Royal Oak、Michigan、美国、48073
- Associated Retinal Consultants
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Missouri
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Kansas City、Missouri、美国、64108
- Eye Foundation of Kansas City
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North Carolina
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Charlotte、North Carolina、美国、28210
- Charlotte Eye, Ear, Nose and Throat Associates, P.A.
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Durham、North Carolina、美国、27710
- Duke University Eye Center
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Ohio
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Cleveland、Ohio、美国、44195
- The Cleveland Clinic
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Lakewood、Ohio、美国、44107
- Retina Associates of Cleveland Inc.
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Oklahoma
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Oklahoma City、Oklahoma、美国、73104
- Dean A. McGee Eye Institute
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Oregon
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Portland、Oregon、美国、97239
- Casey Eye Institute
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Pennsylvania
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Philadelphia、Pennsylvania、美国、19107
- Wills Eye Institute Retina Research
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South Carolina
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Columbia、South Carolina、美国、29204
- Palmetto Retina Center
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Tennessee
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Knoxville、Tennessee、美国、37909
- Southeastern Retina Associates
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Texas
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Abilene、Texas、美国、79606
- Retina Research Institute of Texas, LLC
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Austin、Texas、美国、78705
- Austin Retina Associates
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Dallas、Texas、美国、75231
- Texas Retina Associates
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Houston、Texas、美国、77030
- Vitreoretinal Consultants
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McAllen、Texas、美国、78503
- Valley Retina Associates, P.A.
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Wisconsin
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Madison、Wisconsin、美国、53705
- University of Wisconsin
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Milwaukee、Wisconsin、美国、53226
- The Eye Institute
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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
Inclusion Criteria:
- CRVO must have occurred within the past 6 months and be associated with macular edema determined by OCT.
- Vision in the study eye corresponding to between approximately 20/50 to 20/400 and better than or equal to approximately 20/200 in the fellow eye.
Exclusion Criteria:
- Presence of signs of old branch retinal vein occlusion (BRVO) or CRVO in the study eye or any other retinal vascular disease including diabetic retinopathy.
- Vitreous hemorrhage except breakthrough hemorrhage from intraretinal hemorrhage.
- Prior pan retinal photocoagulation (PRP) or sector scatter photocoagulation.
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:双倍的
合作者和调查者
合作者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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.
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