A Depot Formulation of Sunitinib Malate (GB-102) in Subjects With Diabetic Macular Edema and Retinal Vein Occlusion

• Status: Completed
• Trial end date: 2020-06-05
• Target enrollment: 0
• Participant gender: All

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 with Diabetic Macular Edema and Retinal Vein Occlusion

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Graybug Vision
• Treatments: Sunitinib

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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