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

Study Overview
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Brief Summary
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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
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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)

Official Title
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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)

Conditions
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Diabetic Macular Edema, Retina Vein Occlusion

Intervention / Treatment
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* Drug: GB-102


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel-arm design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GB-102 Dose 1 (1 mg)<br>Participants will receive intravitreal (IVT) GB-102 (1 mg) in the study eye at Baseline. | Drug: GB-102<br>* Intravitreal injection of GB-102<br>* Other names: Sunitinib malate;|
| Experimental: GB-102 Dose 2 (2 mg)<br>Participants will receive intravitreal (IVT) GB-102 (2 mg) in the study eye at Baseline. | Drug: GB-102<br>* Intravitreal injection of GB-102<br>* Other names: Sunitinib malate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of Adverse Events (AEs) Across All Study Visits | Number of subjects with an adverse event across all study visits | Baseline through Month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | Baseline to Month 6 | 
| Time to Rescue Treatment | Assessment of time to rescue treatment over 6 months of treatment | Baseline through Month 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Macular Edema