Safety and Efficacy of Repeated Intravitreal Administration of Vascular Endothelial Growth Factor (VEGF) Trap in Patients With Wet Age-Related Macular Degeneration (AMD)
NCT ID: NCT00320788
Last Updated: 2012-03-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
159 participants
INTERVENTIONAL
2006-04-30
2008-08-31
Brief Summary
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The purpose of this trial is to assess the ocular and systemic safety and tolerability of repeated intravitreal doses of VEGF Trap in patients with subfoveal choroidal neovascularization (CNV) due to AMD.
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Detailed Description
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After Week 12, patients will be evaluated every 4 weeks. Patients will remain on study or may be eligible to enter a long-term extension study, in which they will continue to receive VEGF Trap.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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aflibercept injection (VEGF Trap-Eye, BAY86-5321) 0.5mg q4
aflibercept injection (VEGF Trap-Eye, BAY86-5321)
Participants received 0.5 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 4 week intervals through Week 12
aflibercept injection (VEGF Trap-Eye, BAY86-5321) 0.5mg q12
aflibercept injection (VEGF Trap-Eye, BAY86-5321)
Participants received 0.5 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 12 week intervals through Week 12.
aflibercept injection (VEGF Trap-Eye, BAY86-5321) 2.0mg q4
aflibercept injection (VEGF Trap-Eye, BAY86-5321)
Participants received 2.0 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 4 week intervals through Week 12
aflibercept injection (VEGF Trap-Eye, BAY86-5321) 2.0mg q12
aflibercept injection (VEGF Trap-Eye, BAY86-5321)
Participants received 2.0 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 12 week intervals through Week 12.
aflibercept injection (VEGF Trap-Eye, BAY86-5321) 4.0mg q12
aflibercept injection (VEGF Trap-Eye, BAY86-5321)
Participants received 4.0 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 12 week intervals through Week 12.
Interventions
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aflibercept injection (VEGF Trap-Eye, BAY86-5321)
Participants received 0.5 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 4 week intervals through Week 12
aflibercept injection (VEGF Trap-Eye, BAY86-5321)
Participants received 0.5 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 12 week intervals through Week 12.
aflibercept injection (VEGF Trap-Eye, BAY86-5321)
Participants received 2.0 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 4 week intervals through Week 12
aflibercept injection (VEGF Trap-Eye, BAY86-5321)
Participants received 2.0 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 12 week intervals through Week 12.
aflibercept injection (VEGF Trap-Eye, BAY86-5321)
Participants received 4.0 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 12 week intervals through Week 12.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Central retinal (including lesion) thickness ≥ 300 µm as measured by Optical Coherence Tomography (OCT).
* Early Treatment of Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity of 73 letters to 34 letters.
Exclusion Criteria
* Aphakia.
* Significant subfoveal atrophy or scarring.
* Prior treatment with the following in the study eye:
* Subfoveal thermal laser therapy.
* Submacular surgery or other surgical intervention for the treatment of AMD.
* Extrafoveal laser coagulation treatment within 12 weeks prior to Day 1.
* Photodynamic therapy (PDT) within 12 weeks prior to Visit 2 (Day 1).
* Pegaptanib sodium (Macugen) within 8 weeks of Visit 2 (Day 1).
* Juxtascleral steroids or anecortave acetate within 24 weeks (6 months) prior to Visit 2 (Day 1).
* Intravitreal administration of triamcinolone acetonide or other steroids within 24 weeks prior to Visit 2 (Day 1), unless no visible residue of drug substance can be seen in the vitreous cavity using indirect ophthalmoscopy.
* Prior systemic or intravitreal treatment with VEGF Trap, ranibizumab (Lucentis) or bevacizumab (Avastin).
* Presence of any other condition or laboratory abnormality, which, in the opinion of the Investigator, would interfere with the assessment of disease status/progression or jeopardize the patient's appropriate participation in this Phase II study.
50 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
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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Associated Retina Consultants
Phoenix, Arizona, United States
Retina Centers, PC
Tucson, Arizona, United States
Retina Vitreous Associates Medical Group
Beverly Hills, California, United States
Loma Linda University Health Care
Loma Linda, California, United States
Southeast Retina Center
Augusta, Georgia, United States
University of Chicago
Chicago, Illinois, United States
Midwest Eye Institute
Indianapolis, Indiana, United States
Johns Hopkins Hospital School of Medicine
Baltimore, Maryland, United States
Ophthalmic Consultants of Boston
Boston, Massachusetts, United States
New England Retina Consultants PC
West Springfield, Massachusetts, United States
Charlotte Eye, Ear, Nose & Throat Asssociates
Charlotte, North Carolina, United States
Dean A. McGee Eye Institute
Oklahoma City, Oklahoma, United States
Retina Northwest PC
Portland, Oregon, United States
Retina Diagnostic and Treatment Assoc., LLC
Philadelphia, Pennsylvania, United States
Black Hills Regional Eye Institute
Rapid City, South Dakota, United States
Retina-Vitreous Associates, P.C.
Nashville, Tennessee, United States
Vitreoretinal Consultants Scurlock Tower Texas Medical Center
Houston, Texas, United States
Medical Center Ophthamology
San Antonio, Texas, United States
Countries
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References
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Li E, Donati S, Lindsley KB, Krzystolik MG, Virgili G. Treatment regimens for administration of anti-vascular endothelial growth factor agents for neovascular age-related macular degeneration. Cochrane Database Syst Rev. 2020 May 5;5(5):CD012208. doi: 10.1002/14651858.CD012208.pub2.
Related Links
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Primary endpoint results of a phase II study of vascular endothelial growth factor trap-eye in wet age-related macular degeneration.
The 1-year results of CLEAR-IT 2, a phase 2 study of vascular endothelial growth factor trap-eye dosed as-needed after 12-week fixed dosing.
Other Identifiers
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VGFT-OD-0508
Identifier Type: -
Identifier Source: org_study_id
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