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

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ClinicalTrials.gov Identifier: NCT00964795
Recruitment Status : Completed
First Posted : August 25, 2009
Results First Posted : March 23, 2015
Last Update Posted : March 23, 2015
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Neovascular Age-related Macular Degeneration Drug: Intravitreal Aflibercept Injection 2mg Phase 3

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 323 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Long-term, Safety and Tolerability Extension Study of Intravitreal VEGF Trap-Eye in Neovascular Age-Related Macular Degeneration
Study Start Date : December 2009
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 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.
Drug: Intravitreal Aflibercept Injection 2mg
Other Name: IAI; EYLEA®; BAY86-5321; VEGF Trap-Eye

Primary Outcome Measures :
  1. Safety and Tolerability of Intravitreal Aflibercept Injection in Participants With Neovascular AMD [ Time Frame: 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

Secondary Outcome Measures :
  1. Change in BCVA Letter Score (mLOCF) [ Time Frame: 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).

Other Outcome Measures:
  1. Summary of Treatment Duration (Weeks) [ Time Frame: Baseline through end of treatment (Week 180) ]
    Treatment Duration = (last dose date - first dose date + 28)/7

  2. Summary of Study Duration (Weeks) [ Time Frame: Baseline through end of treatment (Week 180) ]
    Study Duration = (last visit/ discontinuation date - first dose date + 28)/7

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00964795

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United States, Alabama
Birmingham (2 locations), Alabama, United States
United States, Arizona
Phoenix (2 locations), Arizona, United States
Tucson (2 locations), Arizona, United States
United States, California
Arcadia, California, United States
Beverly Hills, California, United States
Campbell, California, United States
Fresno, California, United States
Fullerton, California, United States
La Jolla, California, United States
Loma Linda, California, United States
Mountain View, California, United States
Oakland, California, United States
Orange, California, United States
Palm Desert, California, United States
Sacramento, California, United States
San Mateo, California, United States
Santa Ana, California, United States
Torrance, California, United States
Westlake Village, California, United States
Yorba Linda, California, United States
United States, Colorado
Colorado Springs, Colorado, United States
Denver (2 Locations), Colorado, United States
United States, Connecticut
Bridgeport, Connecticut, United States
New Haven, Connecticut, United States
New London, Connecticut, United States
United States, Florida
Altamonte Springs, Florida, United States
Boynton Beach, Florida, United States
Fort Myers (2 locations), Florida, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Orlando (2 locations), Florida, United States
Oscala, Florida, United States
Palm Beach Gardens, Florida, United States
Pensacola, Florida, United States
Stuart, Florida, United States
Tampa, Florida, United States
Winter Haven, Florida, United States
United States, Georgia
Augusta, Georgia, United States
United States, Hawaii
Aiea, Hawaii, United States
United States, Illinois
Glenview, Illinois, United States
United States, Indiana
Fort Wayne, Indiana, United States
Indianapolis, Indiana, United States
New Albany, Indiana, United States
United States, Iowa
Iowa City, Iowa, United States
United States, Kansas
Wichita, Kansas, United States
United States, Kentucky
Louisville, Kentucky, United States
United States, Louisiana
New Orleans, Louisiana, United States
United States, Maine
Bangor, Maine, United States
Portland, Maine, United States
United States, Maryland
Baltimore (3 Locations), Maryland, United States
Chevy Chase, Maryland, United States
Hagerstown, Maryland, United States
United States, Massachusetts
Boston (2 Locations), Massachusetts, United States
Peabody, Massachusetts, United States
United States, Michigan
Ann Arbor, Michigan, United States
Battle Creek, Michigan, United States
Grand Rapids, Michigan, United States
Jackson, Michigan, United States
Southfield, Michigan, United States
United States, Minnesota
Minneapolis, Minnesota, United States
Rochester, Minnesota, United States
United States, Missouri
Florissant, Missouri, United States
Kansas City, Missouri, United States
Springfield, Missouri, United States
St. Louis, Missouri, United States
United States, Montana
Missoula, Montana, United States
United States, Nebraska
Lincoln, Nebraska, United States
United States, Nevada
Las Vegas, Nevada, United States
United States, New Hampshire
Portsmouth, New Hampshire, United States
United States, New Jersey
Lawrenceville, New Jersey, United States
Northfield, New Jersey, United States
Toms River, New Jersey, United States
United States, New Mexico
Albuquerque, New Mexico, United States
United States, New York
Albany, New York, United States
Brooklyn, New York, United States
Lynbrook, New York, United States
New York (6 locations), New York, United States
Rochester (2 locations), New York, United States
Slingerlands, New York, United States
Syracuse, New York, United States
United States, North Carolina
Asheville, North Carolina, United States
Charlotte, North Carolina, United States
Raleigh, North Carolina, United States
Winston-Salem, North Carolina, United States
United States, Ohio
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
United States, Oklahoma
Oklahoma City, Oklahoma, United States
United States, Oregon
Ashland, Oregon, United States
Portland (3 Locations), Oregon, United States
Salem, Oregon, United States
United States, Pennsylvania
Kingston, Pennsylvania, United States
Philadelphia (3 locations), Pennsylvania, United States
Pittsburgh (2 locations), Pennsylvania, United States
West Mifflin, Pennsylvania, United States
United States, South Carolina
Columbia, South Carolina, United States
Greenville, South Carolina, United States
West Columbia, South Carolina, United States
United States, South Dakota
Rapid City, South Dakota, United States
United States, Tennessee
Nashville, Tennessee, United States
United States, Texas
Austin (3 Locations), Texas, United States
Dallas, Texas, United States
Fort Worth (2 locations), Texas, United States
Houston, Texas, United States
McAllen, Texas, United States
Odessa, Texas, United States
San Antonio (2 locations), Texas, United States
Tyler, Texas, United States
United States, Utah
Salt Lake City (2 locations), Utah, United States
United States, Vermont
Burlington, Vermont, United States
United States, Virginia
Charlottesville, Virginia, United States
Fairfax, Virginia, United States
Richmond, Virginia, United States
United States, Washington
Seattle, Washington, United States
United States, Wisconsin
Madison (2 Locations), Wisconsin, United States
Milwaukee, Wisconsin, United States
Canada, Alberta
Calgary, Alberta, Canada
Canada, British Columbia
Vancouver, British Columbia, Canada
Victoria, British Columbia, Canada
Canada, Nova Scotia
Halifax, Nova Scotia, Canada
Canada, Ontario
London, Ontario, Canada
Mississauga, Ontario, Canada
Ottawa, Ontario, Canada
Canada, Quebec
Montreal (2 locations), Quebec, Canada
Canada, Saskatchewan
Regina, Saskatchewan, Canada
Sponsors and Collaborators
Regeneron Pharmaceuticals
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Study Director: Clinical Trial Management Regeneron Pharmaceuticals
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Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00964795    
Other Study ID Numbers: VGFT-OD-0910
First Posted: August 25, 2009    Key Record Dates
Results First Posted: March 23, 2015
Last Update Posted: March 23, 2015
Last Verified: March 2015
Keywords provided by Regeneron Pharmaceuticals:
Macular Degeneration
VEGF Trap-Eye
Best Corrected Visual Acuity
Additional relevant MeSH terms:
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Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents