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

• Status: Completed
• Trial end date: 2019-01-16
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and efficacy of single and repeated intravitreal injections of GB-102 in subjects with neovascular (wet) age-related macular degeneration.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

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

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