Study to Assess Best Corrected Visual Acuity (BCVA) in Patients With Neovascular Age-Related Macular Degeneration (AMD) Who Are Administered VEGF Trap-Eye (Intravitreal Aflibercept Injection)
NCT ID: NCT01722045
Last Updated: 2017-12-22
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE4
154 participants
INTERVENTIONAL
2012-11-30
2015-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Open label IAI
Intravitreal Aflibercept Injection (IAI)
Interventions
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Intravitreal Aflibercept Injection (IAI)
Eligibility Criteria
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Inclusion Criteria
2. BCVA ETDRS letter score of 73 to 24 (20/40 to 20/320) in the study eye
3. Active primary subfoveal choroidal neovascularization (CNV) lesions secondary to AMD, including juxtafoveal lesions that affect the fovea as evidenced by FA in the study eye
4. The CNV area must be at least 50% of total lesion size
5. Willing and able to comply with clinic visits and study-related procedures
6. Provide signed informed consent
7. Provide signed Health Insurance Portability and Accountability Act (HIPAA) authorization
Exclusion Criteria
2. Corneal endothelial measures as judged by an independent reading center
3. Any prior use of intraocular anti-VEGF treatment for neovascular AMD in either eye
4. Structural damage to the center of the macula in the study eye that is likely to preclude improvement in BCVA following the resolution of macular edema
5. History of cataract surgery, or other intraocular surgery in either eye, within 1 year of screening
6. History of cataract surgery, or other intraocular surgery in either eye, within 1 year of screening, or yttrium aluminum garnet (YAG) Capsulotomy within 3 months of screening
7. Contact lens wear in either eye within 6 months of screening
8. History of angle closure glaucoma in either eye
9. Intraocular laser therapy including selective laser trabeculoplasty (SLT), YAG, prophylactic peripheral iridotomy (PI) in either eye within 1 year of screening, or YAG Capsulotomy within 3 months of screening
10. History of cataract surgery requiring an anterior chamber intraocular lens implant at any time in either eye
11. Any prior ocular trauma (blunt or penetrating) in either eye
12. Embedded corneal foreign body in either eye
13. Evidence of infectious blepharitis, keratitis, scleritis, or conjunctivitis in either eye
14. Ocular media of insufficient quality to obtain fundus and OCT images in the study eye
15. Any prior ocular inflammation/infection in either eye within 3 months of the screening visit
16. Any prior use of amantadine
17. Significant pre-retinal fibrosis involving the macula in the study eye (where, in the opinion of the investigator, the pre-retinal fibrosis is causing distortion or traction on the central macular region which may be limiting vision, or inducing retinal edema/thickening, beyond that due to underlying CNV)
18. Intraocular pressure (IOP) greater than or equal to 30 mm Hg in the study eye at screening
19. Uncontrolled diabetes mellitus (DM) (HbA1c ≥8)
20. Current treatment with systemic anti-VEGF therapeutics at screening
21. Known serious allergy to the fluorescein sodium for injection in angiography
22. Participation in an investigational study within 30 days prior to the screening visit that involved treatment with any drug (excluding vitamins and minerals) or device.
23. Positive serum hCG pregnancy test at the screening visit
50 Years
ALL
No
Sponsors
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Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trial Management
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
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Phoenix, Arizona, United States
Tucson, Arizona, United States
Beverly Hills, California, United States
Oakland, California, United States
Palm Desert, California, United States
Sacramento, California, United States
Santa Ana, California, United States
Westlake Village, California, United States
Colorado Springs, Colorado, United States
Golden, Colorado, United States
Boynton Beach, Florida, United States
Fort Lauderdale, Florida, United States
Fort Myers, Florida, United States
Pensacola, Florida, United States
Plantation, Florida, United States
Tampa, Florida, United States
Winter Haven, Florida, United States
Augusta, Georgia, United States
Oak Park, Illinois, United States
New Albany, Indiana, United States
Wichita, Kansas, United States
Lexington, Kentucky, United States
Boston, Massachusetts, United States
Worcester, Massachusetts, United States
Jackson, Michigan, United States
Lincoln, Nebraska, United States
Las Vegas, Nevada, United States
Portsmouth, New Hampshire, United States
Bloomfield, New Jersey, United States
Lawrenceville, New Jersey, United States
Northfield, New Jersey, United States
Teaneck, New Jersey, United States
Rochester, New York, United States
Asheville, North Carolina, United States
Oklahoma City, Oklahoma, United States
Portland, Oregon, United States
Salem, Oregon, United States
Kingston, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Florence, South Carolina, United States
Ladson, South Carolina, United States
West Columbia, South Carolina, United States
Rapid City, South Dakota, United States
Nashville, Tennessee, United States
Arlington, Texas, United States
Fort Worth, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Seattle, Washington, United States
Countries
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Other Identifiers
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VGFTe-AMD-1124
Identifier Type: -
Identifier Source: org_study_id