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 |
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Recruitment Status :
Completed
First Posted : August 25, 2009
Results First Posted : March 23, 2015
Last Update Posted : March 23, 2015
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Sponsor:
Regeneron Pharmaceuticals
Collaborator:
Bayer
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
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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 |
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.
| 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
MedlinePlus Genetics related topics:
Age-related macular degeneration
MedlinePlus related topics:
Macular Degeneration
| Arm | Intervention/treatment |
|---|---|
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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.
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Drug: Intravitreal Aflibercept Injection 2mg
Other Name: IAI; EYLEA®; BAY86-5321; VEGF Trap-Eye |
Primary Outcome Measures :
- 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 :
- 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:
- Summary of Treatment Duration (Weeks) [ Time Frame: Baseline through end of treatment (Week 180) ]Treatment Duration = (last dose date - first dose date + 28)/7
- 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 |
Criteria
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
Locations
Hide 124 study locations
| 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
Bayer
Investigators
| Study Director: | Clinical Trial Management | Regeneron Pharmaceuticals |
| 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:
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Eyes Neovascular Macular Degeneration Retina |
AMD VEGF Trap-Eye Best Corrected Visual Acuity |
Additional relevant MeSH terms:
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Macular Degeneration Wet Macular Degeneration Retinal Degeneration Aflibercept Retinal Diseases Eye Diseases |
Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Antineoplastic Agents |