Status:
COMPLETED
A Depot Formulation of Sunitinib Malate (GB-102) in Subjects With Diabetic Macular Edema and Retinal Vein Occlusion
Lead Sponsor:
Graybug Vision
Conditions:
Diabetic Macular Edema
Retina Vein Occlusion
Eligibility:
All Genders
21+ years
Phase:
PHASE2
Brief Summary
Phase 2a multicenter, open-label, parallel-arm design study to evaluate the safety, tolerability and pharmacodynamics of a single intravitreal injection comparing 2 dose levels of GB-102 on subjects w...
Detailed Description
Phase 2a multicenter, open-label, parallel-arm design study to evaluate the safety, tolerability and pharmacodynamics of a single intravitreal injection comparing 2 dose levels (1 mg and 2 mg) of GB-1...
Eligibility Criteria
Inclusion
- Males or females ≥ 21 years of age
- 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
- History, within 6 months prior to screening, of any of the following: myocardial infarction, any cardiac event requiring hospitalization, treatment for acute congestive heart failure, transient ischemic attack, or stroke
- Uncontrolled hypertension, diabetes mellitus or IOP
- Chronic renal disease
Key Trial Info
Start Date :
September 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 5 2020
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT04085341
Start Date
September 11 2019
End Date
June 5 2020
Last Update
November 22 2021
Active Locations (6)
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1
Retinal Research Institute
Phoenix, Arizona, United States, 85053
2
Southern Retina
Savannah, Georgia, United States, 31405
3
Eye Care Institute
Louisville, Kentucky, United States, 40206
4
Boston Retina
Boston, Massachusetts, United States, 02482