A 24 Month Phase 2a Open Label, Randomized Study of Avastin®, Lucentis®, or Eylea® (Anti-VEGF Therapy) Administered in Combination With Fovista® (Anti-PDGF BB Pegylated Aptamer)
NCT ID: NCT02387957
Last Updated: 2024-10-30
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
63 participants
INTERVENTIONAL
2016-04-26
2017-01-31
Brief Summary
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Detailed Description
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* Avastin® 1.25 mg/eye (20 subjects)
* Lucentis® 0.5 mg/eye (20 subjects)
* Eylea® 2.0 mg/eye (20 subjects)
Subjects will be stratified by lesion size (≤2 DA vs. \>2 DA).
Subjects will be treated with "combination therapy" of IVT Fovista® and IVT anti-VEGF therapy every month for the first 5 months (Day 1, Months 1,2,3,4), followed by Q12W (every 12 weeks) administration (Months 7,10, 13,16, 19 and 22), for a total of 24 months.
When administered, IVT Fovista® will be given first, followed by IVT anti-VEGF (same day).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Fovista® plus bevacizumab
Fovista® 1.5 mg intravitreal injection + bevacizumab 1.25 mg intravitreal injection
Fovista®
bevacizumab
Fovista® plus ranibizumab
Fovista® 1.5 mg intravitreal injection + 0.5 mg ranibizumab intravitreal injection
Fovista®
ranibizumab
Fovista® plus aflibercept
Fovista® 1.5 mg intravitreal injection + 2.0 mg aflibercept intravitreal injection
Fovista®
aflibercept
Interventions
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Fovista®
bevacizumab
ranibizumab
aflibercept
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Active subfoveal choroidal neovascularization (CNV) due to AMD.
Exclusion Criteria
* Subjects with subfoveal scar or subfoveal atrophy
* Any ocular or periocular infection in the past twelve (12) weeks.
* History of any of the following conditions or procedures in the study eye: Rhegmatogenous retinal detachment, pars plana vitrectomy, filtering surgery (e.g. trabeculectomy), glaucoma drainage device, corneal transplant.
50 Years
ALL
No
Sponsors
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Ophthotech Corporation
INDUSTRY
Responsible Party
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Locations
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Phoenix, Arizona, United States
Beverly Hills, California, United States
Sacramento, California, United States
Santa Ana, California, United States
New London, Connecticut, United States
Fort Lauderdale, Florida, United States
Fort Myers, Florida, United States
Augusta, Georgia, United States
Oak Forest, Illinois, United States
Boston, Massachusetts, United States
Worcester, Massachusetts, United States
Southfield, Michigan, United States
Minneapolis, Minnesota, United States
Reno, Nevada, United States
Rochester, New York, United States
Cleveland, Ohio, United States
Huntingdon Valley, Pennsylvania, United States
Ladson, South Carolina, United States
Abilene, Texas, United States
Amarillo, Texas, United States
San Antonio, Texas, United States
The Woodlands, Texas, United States
Silverdale, Washington, United States
Morgantown, West Virginia, United States
Countries
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Other Identifiers
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OPH1006
Identifier Type: -
Identifier Source: org_study_id
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