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

Completed · Phase 2

Conditions studied: Neovascular Age-Related Macular Degeneration

In brief

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.

Key facts

Study ID

NCT03953079

Run by

Graybug Vision

People needed

56

Starts

2019-09-26

Expected to finish

2021-06-03

Last updated by the study team

2022-01-19

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Retinal Consultants AZ — Gilbert, Arizona, United States
• Retinal Research Institute — Phoenix, Arizona, United States
• California Retina Research Consultants — Bakersfield, California, United States
• Retinal Diagnostic Center of Northern California — Campbell, California, United States
• The Retina Partners — Encino, California, United States
• Retina Consultants of Orange County — Fullerton, California, United States
• Northern California Retina Vitreous Associates Medical Group, Inc. — Mountain View, California, United States
• West Coast Retina Medical Group, Inc. — San Francisco, California, United States
• California Retina Consultants - CRC — Santa Barbara, California, United States
• Bay Area Retina Associates — Walnut Creek, California, United States
• Specialty Retina Center — Coral Springs, Florida, United States
• Florida Retina Institute — Orlando, Florida, United States
• Retina Specialty Institute — Pensacola, Florida, United States
• Eye Associates of Pinellas — Pinellas Park, Florida, United States
• Southeast Retina Center — Augusta, Georgia, United States
• Retina Consultants of Hawaii — ‘Aiea, Hawaii, United States
• University Retina and Macula — Lemont, Illinois, United States
• Wolfe Eye Clinic - West Des Moines — Des Moines, Iowa, United States
• Eye Associates of Northeast Louisiana — West Monroe, Louisiana, United States
• Cumberland Valley Retina Consultants — Hagerstown, Maryland, United States
• Mid Atlantic Retina Specialists — Hagerstown, Maryland, United States
• Sierra Eye Associates — Reno, Nevada, United States
• Ophthalmic Consultants of Long Island — Oceanside, New York, United States
• Sterling Research — Cincinnati, Ohio, United States
• Black Hills Regional Eye Institute — Rapid City, South Dakota, United States

Full record on ClinicalTrials.gov

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