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

Diabetic Macular Edema Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04085341
• Other study ID #: GBV-102-003
• Status: Completed
• Phase: Phase 2
• Start date: September 11, 2019
• Est. completion date: June 5, 2020

Study information

• Verified date: November 2021
• Source: Graybug Vision
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: June 5, 2020
• Est. primary completion date: June 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema
• Retina Vein Occlusion
• Retinal Vein Occlusion

Intervention

Drug:
• GB-102
Intravitreal injection of GB-102

Locations

Country	Name	City	State
United States	Boston Retina	Boston	Massachusetts
United States	Texoma Retina Center	Denison	Texas
United States	Eye Care Institute	Louisville	Kentucky
United States	Retinal Research Institute	Phoenix	Arizona
United States	Sierra Eye Associates	Reno	Nevada
United States	Southern Retina	Savannah	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Graybug Vision

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Time to Rescue Treatment	Assessment of time to rescue treatment over 6 months of treatment	Baseline through Month 6