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

Launched by GRAYBUG VISION · Sep 9, 2019

Keywords

ClinConnect 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 (1 mg and 2 mg) of GB-102 on subjects with Diabetic Macular Edema and Retinal Vein Occlusion who have received prior treatment with anti-vascular endothelial growth factor (VEGF)

Gender

ALL

Eligibility 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