A Depot Formulation of Sunitinib Malate (GB-102) in Subjects With Diabetic Macular Edema and Retinal Vein Occlusion

Completed · Phase 2

Conditions studied: Diabetic Macular Edema, Retina Vein Occlusion

In brief

Phase 2a multicenter, open-label, parallel-arm design study to evaluate the safety, tolerability and pharmacodynamics of a single intravitreal injection comparing 2 dose levels of GB-102 on subjects with Diabetic Macular Edema and Retinal Vein Occlusion

Key facts

Study ID

NCT04085341

Run by

Graybug Vision

People needed

21

Starts

2019-09-11

Expected to finish

2020-06-05

Last updated by the study team

2021-11-22

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males or females ≥ 21 years of age
• Known diagnosis of macular edema secondary to diabetic macular edema or retinal vein occlusion 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 31 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 IOP
• Chronic renal disease

Where it is running

• Retinal Research Institute — Phoenix, Arizona, United States
• Southern Retina — Savannah, Georgia, United States
• Eye Care Institute — Louisville, Kentucky, United States
• Boston Retina — Boston, Massachusetts, United States
• Sierra Eye Associates — Reno, Nevada, United States
• Texoma Retina Center — Denison, Texas, United States

Full record on ClinicalTrials.gov

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