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

Phase 2

Completed

• Conditions: Diabetic Macular Edema; Retina Vein Occlusion
• Interventions: Drug: GB-102

• Registration Number: NCT04085341
• Lead Sponsor: Graybug Vision

Brief Summary

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

Detailed Description

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 Timeline

• Study First Submitted: 2019-09-09
• Study First Submitted QC: 2019-09-09
• Study Start: 2019-09-11
• Study First Posted: 2019-09-11
• Primary Completion: 2020-06-05
• Study Completion: 2020-06-05
• Results First Submitted: 2021-05-27
• Results First Submitted QC: 2021-07-13
• Results First Posted: 2021-07-15
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-18
• Last Update Posted: 2021-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GB-102 Dose 1 (1 mg)	GB-102	Participants will receive intravitreal (IVT) GB-102 (1 mg) in the study eye at Baseline.
GB-102 Dose 2 (2 mg)	GB-102	Participants will receive intravitreal (IVT) GB-102 (2 mg) in the study eye at Baseline.

Primary Outcome Measures

Name	Time	Method
Occurrence of Adverse Events (AEs) Across All Study Visits	Baseline through Month 6	Number of subjects with an adverse event across all study visits

Secondary Outcome Measures

Name	Time	Method
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) (ETDRS) at All Study Visits	Baseline to Month 6	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
Mean Change From Baseline in Central Subfield Thickness (CST) (SD-OCT) at All Study Visits	Baseline to Month 6	CST = central subfield thickness; SD-OCT = spectral domain-optical coherence tomography; Assessment of change in CST (μm) measurement from baseline at all visits
Time to Rescue Treatment	Baseline through Month 6	Assessment of time to rescue treatment over 6 months of treatment

Trial Locations

Locations (6)

Sierra Eye Associates; 🇺🇸 Reno, Nevada, United States

Texoma Retina Center; 🇺🇸 Denison, Texas, United States

Boston Retina; 🇺🇸 Boston, Massachusetts, United States

Retinal Research Institute; 🇺🇸 Phoenix, Arizona, United States

Eye Care Institute; 🇺🇸 Louisville, Kentucky, United States

Southern Retina; 🇺🇸 Savannah, Georgia, United States