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

Graybug Vision21 enrolled

Overview

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

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 (1 mg and 2 mg) of GB-102 on subjects with Diabetic Macular Edema and Retinal Vein Occlusion who have received prior treatment with anti-vascular endothelial growth factor (VEGF)

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetic Macular Edema Retina Vein Occlusion

Interventions

GB-102DRUG

Intravitreal injection of GB-102

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Locations (6)

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

Outcomes

Primary Outcomes

Occurrence of Adverse Events (AEs) Across All Study Visits

Number of subjects with an adverse event across all study visits

Time frame: Baseline through Month 6

Secondary Outcomes

Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) (ETDRS) at All Study Visits

BCVA = best corrected visual acuity; ETDRS = early treatment of diabetic retinopathy BCVA = 0 (worst) to 100 (best) Assessment of change in BCVA (ETDRS letter score) from baseline at all visits

Time frame: Baseline to Month 6

Mean Change From Baseline in Central Subfield Thickness (CST) (SD-OCT) at All Study Visits

CST = central subfield thickness SD-OCT = spectral domain-optical coherence tomography Assessment of change in CST (μm) measurement from baseline at all visits

Time frame: Baseline to Month 6

Time to Rescue Treatment

Assessment of time to rescue treatment over 6 months of treatment

Time frame: Baseline through Month 6

Data from ClinicalTrials.gov

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