NCT04085341

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

A Phase 2a Multicenter Study Evaluating the Safety, Tolerability, and Pharmacodynamics of Sunitinib Malate Depot Formulation (GB-102) in Subjects With Diabetic Macular Edema (DME) and Retinal Vein Occlusion (RVO)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Graybug Vision · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Diabetic Macular Edema
• Retina Vein Occlusion

Interventions

Type	Name	Description
DRUG	GB-102	Intravitreal injection of GB-102

Timeline

• Start date: 2019-09-11
• Primary completion: 2020-06-05
• Completion: 2020-06-05
• First posted: 2019-09-11
• Last updated: 2021-11-22
• Results posted: 2021-07-15

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study