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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. mars 2015 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Faktiske)

323

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

50 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Legemiddel: Intravitreal Aflibercept Injection 2mg
Andre navn:
  • IAI; EYLEA®; BAY86-5321; VEGF Trap-Eye

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Regeneron Pharmaceuticals

Samarbeidspartnere

Bayer

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. desember 2009

Primær fullføring (Faktiske)

1. august 2013

Studiet fullført (Faktiske)

1. august 2013

Datoer for studieregistrering

Først innsendt

20. august 2009

Først innsendt som oppfylte QC-kriteriene

24. august 2009

Først lagt ut (Anslag)

25. august 2009

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

23. mars 2015

Siste oppdatering sendt inn som oppfylte QC-kriteriene

10. mars 2015

Sist bekreftet

1. mars 2015

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • VGFT-OD-0910

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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