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

• Status: Completed
• Trial end date: 2021-06-03
• Target enrollment: 0
• Participant gender: All

Summary

Phase 2b, multicenter, visual examiner-masked, randomized active-controlled, parallel-arm design study to evaluate the safety and duration of repeated IVT injections of 3 dose levels of GB-102 compared with aflibercept.

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

Details

• Lead Sponsor: Graybug Vision
• Treatments: Aflibercept; Sunitinib

Criteria

Inclusion Criteria:

• Males or females ≥ 50 years of age

• Presence of a CNV lesion secondary to AMD 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 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 IOP

• Chronic renal disease

• Abnormal liver function

• Women who are pregnant or lactating