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Open-label Extension Study of Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) in Neovascular ("Wet") Age-related Macular Degeneration (AMD)

10. marts 2015 opdateret af: Regeneron Pharmaceuticals

An Open-label, Long-term, Safety and Tolerability Extension Study of Intravitreal VEGF Trap-Eye in Neovascular Age-Related Macular Degeneration

The primary objective is to assess long-term safety and tolerability of Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) in patients with neovascular AMD.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The dose evaluated in this study, Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) 2mg, will be the higher of the 2 dose strengths evaluated in parent study VGFT-OD-0605 (NCT00509795) and is the dose level administered in study VGFT-OD-0702 (NCT00527423), a long-term open-label extension study. For these reasons, this dose has been selected for this extension study.

Participants will be seen in the clinic for quarterly visits starting with day 1 to assess safety. Study drug will be administered on an as-needed basis at the discretion of the investigator with a minimum allowed interval of every 4 weeks and a maximum allowed interval of every 12 weeks. This study will assess the frequency that re-treatment is needed and the effect of continued Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) treatment on BCVA.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

323

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Canada
    • Alberta
      • Calgary, Alberta, Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
      • Victoria, British Columbia, Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
    • Ontario
      • London, Ontario, Canada
      • Mississauga, Ontario, Canada
      • Ottawa, Ontario, Canada
    • Quebec
      • Montreal (2 locations), Quebec, Canada
    • Saskatchewan
      • Regina, Saskatchewan, Canada
  • Forenede Stater
    • Alabama
      • Birmingham (2 locations), Alabama, Forenede Stater
    • Arizona
      • Phoenix (2 locations), Arizona, Forenede Stater
      • Tucson (2 locations), Arizona, Forenede Stater
    • California
      • Arcadia, California, Forenede Stater
      • Beverly Hills, California, Forenede Stater
      • Campbell, California, Forenede Stater
      • Fresno, California, Forenede Stater
      • Fullerton, California, Forenede Stater
      • La Jolla, California, Forenede Stater
      • Loma Linda, California, Forenede Stater
      • Mountain View, California, Forenede Stater
      • Oakland, California, Forenede Stater
      • Orange, California, Forenede Stater
      • Palm Desert, California, Forenede Stater
      • Sacramento, California, Forenede Stater
      • San Mateo, California, Forenede Stater
      • Santa Ana, California, Forenede Stater
      • Torrance, California, Forenede Stater
      • Westlake Village, California, Forenede Stater
      • Yorba Linda, California, Forenede Stater
    • Colorado
      • Colorado Springs, Colorado, Forenede Stater
      • Denver (2 Locations), Colorado, Forenede Stater
    • Connecticut
      • Bridgeport, Connecticut, Forenede Stater
      • New Haven, Connecticut, Forenede Stater
      • New London, Connecticut, Forenede Stater
    • Florida
      • Altamonte Springs, Florida, Forenede Stater
      • Boynton Beach, Florida, Forenede Stater
      • Fort Myers (2 locations), Florida, Forenede Stater
      • Jacksonville, Florida, Forenede Stater
      • Miami, Florida, Forenede Stater
      • Orlando (2 locations), Florida, Forenede Stater
      • Oscala, Florida, Forenede Stater
      • Palm Beach Gardens, Florida, Forenede Stater
      • Pensacola, Florida, Forenede Stater
      • Stuart, Florida, Forenede Stater
      • Tampa, Florida, Forenede Stater
      • Winter Haven, Florida, Forenede Stater
    • Georgia
      • Augusta, Georgia, Forenede Stater
    • Hawaii
      • Aiea, Hawaii, Forenede Stater
    • Illinois
      • Glenview, Illinois, Forenede Stater
    • Indiana
      • Fort Wayne, Indiana, Forenede Stater
      • Indianapolis, Indiana, Forenede Stater
      • New Albany, Indiana, Forenede Stater
    • Iowa
      • Iowa City, Iowa, Forenede Stater
    • Kansas
      • Wichita, Kansas, Forenede Stater
    • Kentucky
      • Louisville, Kentucky, Forenede Stater
    • Louisiana
      • New Orleans, Louisiana, Forenede Stater
    • Maine
      • Bangor, Maine, Forenede Stater
      • Portland, Maine, Forenede Stater
    • Maryland
      • Baltimore (3 Locations), Maryland, Forenede Stater
      • Chevy Chase, Maryland, Forenede Stater
      • Hagerstown, Maryland, Forenede Stater
    • Massachusetts
      • Boston (2 Locations), Massachusetts, Forenede Stater
      • Peabody, Massachusetts, Forenede Stater
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater
      • Battle Creek, Michigan, Forenede Stater
      • Grand Rapids, Michigan, Forenede Stater
      • Jackson, Michigan, Forenede Stater
      • Southfield, Michigan, Forenede Stater
    • Minnesota
      • Minneapolis, Minnesota, Forenede Stater
      • Rochester, Minnesota, Forenede Stater
    • Missouri
      • Florissant, Missouri, Forenede Stater
      • Kansas City, Missouri, Forenede Stater
      • Springfield, Missouri, Forenede Stater
      • St. Louis, Missouri, Forenede Stater
    • Montana
      • Missoula, Montana, Forenede Stater
    • Nebraska
      • Lincoln, Nebraska, Forenede Stater
    • Nevada
      • Las Vegas, Nevada, Forenede Stater
    • New Hampshire
      • Portsmouth, New Hampshire, Forenede Stater
    • New Jersey
      • Lawrenceville, New Jersey, Forenede Stater
      • Northfield, New Jersey, Forenede Stater
      • Toms River, New Jersey, Forenede Stater
    • New Mexico
      • Albuquerque, New Mexico, Forenede Stater
    • New York
      • Albany, New York, Forenede Stater
      • Brooklyn, New York, Forenede Stater
      • Lynbrook, New York, Forenede Stater
      • New York (6 locations), New York, Forenede Stater
      • Rochester (2 locations), New York, Forenede Stater
      • Slingerlands, New York, Forenede Stater
      • Syracuse, New York, Forenede Stater
    • North Carolina
      • Asheville, North Carolina, Forenede Stater
      • Charlotte, North Carolina, Forenede Stater
      • Raleigh, North Carolina, Forenede Stater
      • Winston-Salem, North Carolina, Forenede Stater
    • Ohio
      • Cincinnati, Ohio, Forenede Stater
      • Cleveland, Ohio, Forenede Stater
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater
    • Oregon
      • Ashland, Oregon, Forenede Stater
      • Portland (3 Locations), Oregon, Forenede Stater
      • Salem, Oregon, Forenede Stater
    • Pennsylvania
      • Kingston, Pennsylvania, Forenede Stater
      • Philadelphia (3 locations), Pennsylvania, Forenede Stater
      • Pittsburgh (2 locations), Pennsylvania, Forenede Stater
      • West Mifflin, Pennsylvania, Forenede Stater
    • South Carolina
      • Columbia, South Carolina, Forenede Stater
      • Greenville, South Carolina, Forenede Stater
      • West Columbia, South Carolina, Forenede Stater
    • South Dakota
      • Rapid City, South Dakota, Forenede Stater
    • Tennessee
      • Nashville, Tennessee, Forenede Stater
    • Texas
      • Austin (3 Locations), Texas, Forenede Stater
      • Dallas, Texas, Forenede Stater
      • Fort Worth (2 locations), Texas, Forenede Stater
      • Houston, Texas, Forenede Stater
      • McAllen, Texas, Forenede Stater
      • Odessa, Texas, Forenede Stater
      • San Antonio (2 locations), Texas, Forenede Stater
      • Tyler, Texas, Forenede Stater
    • Utah
      • Salt Lake City (2 locations), Utah, Forenede Stater
    • Vermont
      • Burlington, Vermont, Forenede Stater
    • Virginia
      • Charlottesville, Virginia, Forenede Stater
      • Fairfax, Virginia, Forenede Stater
      • Richmond, Virginia, Forenede Stater
    • Washington
      • Seattle, Washington, Forenede Stater
    • Wisconsin
      • Madison (2 Locations), Wisconsin, Forenede Stater
      • Milwaukee, Wisconsin, Forenede Stater

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

50 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Participation in Study VGFT-OD-0605 through week 96.
  • In the opinion of the investigator, the study eye has neovascular AMD and may continue to require treatment.

Exclusion Criteria:

  • Presence of any condition that would jeopardize the patient's participation in this study.
  • Females who are pregnant, breastfeeding, or of childbearing potential, unwilling to practice adequate contraception throughout the study.

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: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Open-label Intravitreal Aflibercept Injection
Open-label Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) 2mg (40 mg/mL) was administered no more frequently than every 4 weeks, but no less frequently than every 12 weeks until amendment 4. Starting with amendment 4, Intravitreal Aflibercept Injection was administered no less frequently than every 8 weeks. Within these limits, the investigator would determine the interval of Intravitreal Aflibercept Injection administration on an as-needed basis according to the protocol-suggested re-treatment criteria, however the injections must have occurred at least every 12 weeks prior to amendment 4, and at least every 8 weeks starting from amendment 4 as noted above.
Medicin: Intravitreal Aflibercept Injection 2mg
Andre navne:
  • IAI; EYLEA®; BAY86-5321; VEGF Trap-Eye

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Safety and Tolerability of Intravitreal Aflibercept Injection in Participants With Neovascular AMD
Tidsramme: Baseline (day 1) through end of treatment (Week 180)

The primary endpoint in the study is the safety and tolerability of Intravitreal Aflibercept Injection in patients with neovascular AMD (Age-related Macular Degeneration) from day 1 through the end of treatment visit (week 180) based on the number of participants who experienced any treatment-emergent adverse event (TEAE).

Treatment-emergent adverse events were categorized according to Ocular TEAEs in the study eye, Ocular TEAEs in the fellow eye, and Non-Ocular TEAEs
Baseline (day 1) through end of treatment (Week 180)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in BCVA Letter Score (mLOCF)
Tidsramme: Baseline through Week 116

The secondary endpoint in the study is the change in BCVA letter score from baseline through Week 116.

(mLOCF: The last non-missing observation prior to the missing visit was carried forward to impute the missing data; no imputation after last visit; no baseline value carried forward).
Baseline through Week 116

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Summary of Treatment Duration (Weeks)
Tidsramme: Baseline through end of treatment (Week 180)
Treatment Duration = (last dose date - first dose date + 28)/7
Baseline through end of treatment (Week 180)
Summary of Study Duration (Weeks)
Tidsramme: Baseline through end of treatment (Week 180)
Study Duration = (last visit/ discontinuation date - first dose date + 28)/7
Baseline through end of treatment (Week 180)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Regeneron Pharmaceuticals

Samarbejdspartnere

Bayer

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. december 2009

Primær færdiggørelse (Faktiske)

1. august 2013

Studieafslutning (Faktiske)

1. august 2013

Datoer for studieregistrering

Først indsendt

20. august 2009

Først indsendt, der opfyldte QC-kriterier

24. august 2009

Først opslået (Skøn)

25. august 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

23. marts 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. marts 2015

Sidst verificeret

1. marts 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • VGFT-OD-0910

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 .

Kliniske forsøg med Intravitreal Aflibercept Injection 2mg

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in China

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner