A Depot Formulation of Sunitinib Malate (GB-102) Compared to Aflibercept in Subjects With Wet AMD

Launched by GRAYBUG VISION · May 14, 2019

Keywords

ClinConnect Summary

Phase 2b, multicenter, visual examiner-masked, randomized active-controlled, parallel-arm design study to evaluate the safety and duration of the effect of GB-102, as measured by time to first rescue treatment across multiple dose levels of GB-102 administered every 6 months as compared to intravitreal (IVT) aflibercept administered every 2 months in subjects with neovascular (wet) age-related macular degeneration who have received prior induction with anti-vascular endothelial growth factor (VEGF)

Extension Study:

To monitor the safety and duration of effect of IVT GB-102 administered ev...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Males or females ≥ 50 years of age
• • 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:
• • 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 intraocular pressure (IOP)
• • Chronic renal disease
• • Abnormal liver function
• • Women who are pregnant or lactating