A Depot Formulation of Sunitinib Malate (GB-102) Compared to Aflibercept in Subjects With Wet AMD
NCT ID: NCT03953079
Last Updated: 2022-01-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
56 participants
INTERVENTIONAL
2019-09-26
2021-06-03
Brief Summary
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Detailed Description
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Extension Study:
To monitor the safety and duration of effect of IVT GB-102 administered every 6 months compared to IVT aflibercept administered every 2 months in subjects in ALTISSIMO (Core Study) who complete all study visits through Month 12 (Day 360) and who do not require/receive rescue treatment at the Month 12 (Day 360) final study visit
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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GB-102 1 mg/1 mg
Participants will receive intravitreal (IVT) GB-102 1 mg in the study eye at Baseline and Month 6 and sham at Months 2, 4, 8 and 10.
Drug: GB-102
Intravitreal injection of GB-102
GB-102 2 mg/1 mg
Participants will receive intravitreal (IVT) GB-102 2 mg in the study eye at Baseline, intravitreal (IVT) GB-102 1 mg at Month 6 and sham at Months 2, 4, 8 and 10.
Drug: GB-102
Intravitreal injection of GB-102
Aflibercept 2 mg
Participants will receive intravitreal (IVT) aflibercept 2 mg in the study eye at Baseline, Months 2, 4, 6, 8 and 10.
Aflibercept
Intravitreal injection of aflibercept (2 mg dose)
Interventions
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Drug: GB-102
Intravitreal injection of GB-102
Aflibercept
Intravitreal injection of aflibercept (2 mg dose)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Presence of a choroidal neovascularization (CNV) lesion secondary to AMD treated with at least 3 prior intravitreal (IVT) injections of an anti-vascular endothelial growth factor (VEGF) agent (aflibercept, bevacizumab, or ranibizumab).
* Demonstrated response to prior anti-VEGF treatment since diagnosis
* Best-corrected visual acuity (BCVA) of 35 letters or better
Exclusion Criteria
* Uncontrolled hypertension, diabetes mellitus or intraocular pressure (IOP)
* Chronic renal disease
* Abnormal liver function
* Women who are pregnant or lactating
50 Years
ALL
No
Sponsors
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Graybug Vision
INDUSTRY
Responsible Party
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Principal Investigators
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Chief Medical Officer
Role: STUDY_DIRECTOR
Graybug Vision, Inc.
Locations
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Retinal Consultants AZ
Gilbert, Arizona, United States
Retinal Research Institute
Phoenix, Arizona, United States
California Retina Research Consultants
Bakersfield, California, United States
Retinal Diagnostic Center of Northern California
Campbell, California, United States
The Retina Partners
Encino, California, United States
Retina Consultants of Orange County
Fullerton, California, United States
Northern California Retina Vitreous Associates Medical Group, Inc.
Mountain View, California, United States
West Coast Retina Medical Group, Inc.
San Francisco, California, United States
California Retina Consultants - CRC
Santa Barbara, California, United States
Bay Area Retina Associates
Walnut Creek, California, United States
Specialty Retina Center
Coral Springs, Florida, United States
Florida Retina Institute
Orlando, Florida, United States
Retina Specialty Institute
Pensacola, Florida, United States
Eye Associates of Pinellas
Pinellas Park, Florida, United States
Southeast Retina Center
Augusta, Georgia, United States
Retina Consultants of Hawaii
‘Aiea, Hawaii, United States
University Retina and Macula
Lemont, Illinois, United States
Wolfe Eye Clinic - West Des Moines
Des Moines, Iowa, United States
Eye Associates of Northeast Louisiana
West Monroe, Louisiana, United States
Cumberland Valley Retina Consultants
Hagerstown, Maryland, United States
Mid Atlantic Retina Specialists
Hagerstown, Maryland, United States
Sierra Eye Associates
Reno, Nevada, United States
Ophthalmic Consultants of Long Island
Oceanside, New York, United States
Sterling Research
Cincinnati, Ohio, United States
Black Hills Regional Eye Institute
Rapid City, South Dakota, United States
Retina Research Institute of Texas
Abilene, Texas, United States
Austin Retina Associates
Austin, Texas, United States
Retina Research Center, PLLC
Austin, Texas, United States
Retina Specialists
Plano, Texas, United States
Retina Consultants of Houston
The Woodlands, Texas, United States
Strategic Clinical Research Group LLC
Willow Park, Texas, United States
Piedmont Eye Center
Lynchburg, Virginia, United States
Retina Center NW PLLC
Silverdale, Washington, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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GBV-102-002
Identifier Type: -
Identifier Source: org_study_id
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