Pegaptanib Sodium Compared to Sham Injection in Patients With Recent Vision Loss Due to Macular Edema Secondary to Central Retinal Vein Occlusion (CRVO)
17. januar 2007 opdateret af: Eyetech Pharmaceuticals
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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This study will consist of 3 phases: a screening phase which will last up to two weeks, a confirmation phase which will last one day, and a randomization phase (the patient will be assigned by chance to a study group in this phase) which will last approximately 52 weeks.
Undersøgelsestype
Interventionel
Tilmelding
90
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Arizona
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Tucson, Arizona, Forenede Stater, 85704
- Retina Centers, P.C., Northwest Location
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Tucson, Arizona, Forenede Stater, 85710
- Retina Associates, SW
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California
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Los Angeles, California, Forenede Stater, 90095
- Jules Stein Institute
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Santa Ana, California, Forenede Stater, 92705
- Orange County Retina Associates
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Connecticut
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Hamden, Connecticut, Forenede Stater, 06518
- New England Retina Associates
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Florida
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Fort Lauderdale, Florida, Forenede Stater, 33334
- Retina Group of Florida
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Miami, Florida, Forenede Stater, 33136
- Bascom Palmer Eye Institute
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Illinois
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Chicago, Illinois, Forenede Stater, 60637
- The University of Chicago
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Indiana
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Indianapolis, Indiana, Forenede Stater, 46280
- Macula-Retina-Vitreous Service
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Kansas
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Wichita, Kansas, Forenede Stater, 67214
- Vitreo-Retinal Consultants & Surgeons, P.A.
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Louisiana
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New Orleans, Louisiana, Forenede Stater, 70155
- Retina Associates
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Maryland
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Chevy Chase, Maryland, Forenede Stater, 20815
- Retina Group of Washington
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Hagerstown, Maryland, Forenede Stater, 21740
- Cumberland Valley Retina Center
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02114
- Massachusetts Eye & Ear Infirmary
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Boston, Massachusetts, Forenede Stater, 02111
- New England Eye Center
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Peabody, Massachusetts, Forenede Stater, 01960
- Lahey Clinic, The Eye Institute
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Michigan
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Detroit, Michigan, Forenede Stater, 48201
- Kresge Eye Institute
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Royal Oak, Michigan, Forenede Stater, 48073
- Associated Retinal Consultants
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Missouri
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Kansas City, Missouri, Forenede Stater, 64108
- Eye Foundation of Kansas City
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North Carolina
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Charlotte, North Carolina, Forenede Stater, 28210
- Charlotte Eye, Ear, Nose and Throat Associates, P.A.
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Durham, North Carolina, Forenede Stater, 27710
- Duke University Eye Center
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Ohio
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Cleveland, Ohio, Forenede Stater, 44195
- The Cleveland Clinic
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Lakewood, Ohio, Forenede Stater, 44107
- Retina Associates of Cleveland Inc.
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Oklahoma
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Oklahoma City, Oklahoma, Forenede Stater, 73104
- Dean A. McGee Eye Institute
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Oregon
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Portland, Oregon, Forenede Stater, 97239
- Casey Eye Institute
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Pennsylvania
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Philadelphia, Pennsylvania, Forenede Stater, 19107
- Wills Eye Institute Retina Research
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South Carolina
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Columbia, South Carolina, Forenede Stater, 29204
- Palmetto Retina Center
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Tennessee
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Knoxville, Tennessee, Forenede Stater, 37909
- Southeastern Retina Associates
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Texas
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Abilene, Texas, Forenede Stater, 79606
- Retina Research Institute of Texas, LLC
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Austin, Texas, Forenede Stater, 78705
- Austin Retina Associates
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Dallas, Texas, Forenede Stater, 75231
- Texas Retina Associates
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Houston, Texas, Forenede Stater, 77030
- Vitreoretinal Consultants
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McAllen, Texas, Forenede Stater, 78503
- Valley Retina Associates, P.A.
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Wisconsin
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Madison, Wisconsin, Forenede Stater, 53705
- University of Wisconsin
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Milwaukee, Wisconsin, Forenede Stater, 53226
- The Eye Institute
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. maj 2004
Datoer for studieregistrering
Først indsendt
23. juli 2004
Først indsendt, der opfyldte QC-kriterier
23. juli 2004
Først opslået (Skøn)
26. juli 2004
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
19. januar 2007
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
17. januar 2007
Sidst verificeret
1. januar 2007
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- EOP 1011B
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .