Status:
COMPLETED
A Depot Formulation of Sunitinib Malate (GB-102) in Subjects With Neovascular (Wet) Age-related Macular Degeneration
Lead Sponsor:
Graybug Vision
Conditions:
Neovascular Age-Related Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
PHASE1
Brief 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.
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Key
- Males or females of any race, ≥ 50 years of age
- 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)
- Evidence of increased vascular permeability and/or loss of visual acuity
- Key
Exclusion
- 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, IOP, hypothyroidism, or hyperthyroidism
- Chronic renal disease
- Abnormal liver function
- Women who are pregnant or lactating
Key Trial Info
Start Date :
August 29 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 16 2019
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT03249740
Start Date
August 29 2017
End Date
January 16 2019
Last Update
December 20 2019
Active Locations (8)
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1
Retinal Consultants of Arizona
Gilbert, Arizona, United States, 85296
2
Retina-Vitreous Associates Medical Group
Beverly Hills, California, United States, 90211
3
Midwest Eye Institute
Indianapolis, Indiana, United States, 46290
4
Ophthalmic Consultants of Long Island
Lynbrook, New York, United States, 11563