A Depot Formulation of Sunitinib Malate (GB-102) in Subjects With Diabetic Macular Edema and Retinal Vein Occlusion
NCT ID: NCT04085341
Last Updated: 2021-11-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
21 participants
INTERVENTIONAL
2019-09-11
2020-06-05
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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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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GB-102 Dose 1 (1 mg)
Participants will receive intravitreal (IVT) GB-102 (1 mg) in the study eye at Baseline.
GB-102
Intravitreal injection of GB-102
GB-102 Dose 2 (2 mg)
Participants will receive intravitreal (IVT) GB-102 (2 mg) in the study eye at Baseline.
GB-102
Intravitreal injection of GB-102
Interventions
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GB-102
Intravitreal injection of GB-102
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Known diagnosis of macular edema secondary to diabetic macular edema or retinal vein occlusion treated with at least 3 prior IVT injections of an anti-VEGF agent (aflibercept, bevacizumab, or ranibizumab)
* Demonstrated response to prior anti-VEGF treatment since diagnosis
* BCVA of 31 letters or better
Exclusion Criteria
* Uncontrolled hypertension, diabetes mellitus or IOP
* Chronic renal disease
21 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 Research Institute
Phoenix, Arizona, United States
Southern Retina
Savannah, Georgia, United States
Eye Care Institute
Louisville, Kentucky, United States
Boston Retina
Boston, Massachusetts, United States
Sierra Eye Associates
Reno, Nevada, United States
Texoma Retina Center
Denison, Texas, 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-102-003
Identifier Type: -
Identifier Source: org_study_id