- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02387957
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)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
60 subjects randomized 1:1:1 and treated with IVT Fovista® 1.5 mg/eye in combination with anti-VEGF therapy as follows:
- 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).
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Arizona
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Phoenix, Arizona, United States, 85014
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California
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Beverly Hills, California, United States, 90211
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Sacramento, California, United States, 95819
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Santa Ana, California, United States, 92705
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Connecticut
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New London, Connecticut, United States, 06320
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Florida
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Fort Lauderdale, Florida, United States, 33308
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Fort Myers, Florida, United States, 33912
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Georgia
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Augusta, Georgia, United States, 30909
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Illinois
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Oak Forest, Illinois, United States, 60452
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Massachusetts
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Boston, Massachusetts, United States, 02114
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Worcester, Massachusetts, United States, 01605
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Michigan
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Southfield, Michigan, United States, 48034
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Minnesota
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Minneapolis, Minnesota, United States, 55435
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Nevada
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Reno, Nevada, United States, 89502
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New York
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Rochester, New York, United States, 14620
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Ohio
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Cleveland, Ohio, United States, 44130
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Pennsylvania
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Huntingdon Valley, Pennsylvania, United States, 19006
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South Carolina
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Ladson, South Carolina, United States, 29456
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Texas
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Abilene, Texas, United States, 85014
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Amarillo, Texas, United States, 79106
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San Antonio, Texas, United States, 78240
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The Woodlands, Texas, United States, 77384
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Washington
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Silverdale, Washington, United States, 98383
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West Virginia
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Morgantown, West Virginia, United States, 26506
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Subjects of either gender aged ≥ 50 years.
- Active subfoveal choroidal neovascularization (CNV) due to AMD.
Exclusion Criteria:
- Any intraocular surgery or thermal laser within three (3) months of trial entry. Any prior thermal laser in the macular region, regardless of indication.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Fovista® plus bevacizumab
Fovista® 1.5 mg intravitreal injection + bevacizumab 1.25 mg intravitreal injection
|
Other Names:
|
Experimental: Fovista® plus ranibizumab
Fovista® 1.5 mg intravitreal injection + 0.5 mg ranibizumab intravitreal injection
|
Other Names:
|
Experimental: Fovista® plus aflibercept
Fovista® 1.5 mg intravitreal injection + 2.0 mg aflibercept intravitreal injection
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total Numer of Systemic Adverse Events
Time Frame: 2 years
|
Number of Patients with Systemic Adverse Events
|
2 years
|
Total Number of Other Adverse Events (>5%)
Time Frame: 2 years
|
Number of Patients with Other Adverse Events
|
2 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OPH1006
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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