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

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Status and phase: Completed; Phase 2

Conditions: Retina Vein Occlusion; Diabetic Macular Edema

Treatments: Drug: GB-102

Study type: Interventional

Funder types: Industry

Identifiers

NCT04085341

GBV-102-003

Details and patient eligibility

About

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

Full 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)

Enrollment: 21 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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21 participants in 2 patient groups

GB-102 Dose 1 (1 mg)

Experimental group

Description:

Participants will receive intravitreal (IVT) GB-102 (1 mg) in the study eye at Baseline.

Treatment:

Drug: GB-102

GB-102 Dose 2 (2 mg)

Experimental group

Description:

Participants will receive intravitreal (IVT) GB-102 (2 mg) in the study eye at Baseline.

Treatment:

Drug: GB-102