A Depot Formulation of Sunitinib Malate (GB-102) in Subjects With Neovascular (Wet) Age-related Macular Degeneration

Launched by GRAYBUG VISION · Aug 10, 2017

Keywords

ClinConnect Summary

In this 2-part study, Part 1 is a multicenter, open-label, safety, tolerability, and systemic exposure evaluation to Sunitinib in escalating doses of a single IVT injection of GB-102, while Part 2 is a multicenter, double-masked, randomized (1:1:1), parallel-group, safety, and efficacy evaluation of repeated IVT injections of 2 dose levels of GB-102 compared with aflibercept.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • 1. Males or females of any race, ≥ 50 years of age
• • 2. Presence of an active CNV lesion secondary to AMD treated with at least 3 monthly injections of an anti-VEGF agent (aflibercept, bevacizumab, or ranibizumab)
• • 3. Evidence of increased vascular permeability and/or loss of visual acuity
• Key Exclusion Criteria:
• • 1. 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
• • 2. Uncontrolled hypertension, diabetes mellitus, IOP, hypothyroidism, or hyperthyroidism
• • 3. Chronic renal disease
• • 4. Abnormal liver function
• • 5. Women who are pregnant or lactating