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)

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

Study Overview

• Status: Completed
• Conditions: Diabetic Macular Edema; Retina Vein Occlusion
• Intervention / Treatment: Drug: GB-102

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 Type: Interventional
• Enrollment (Actual): 21
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85053
      • Retinal Research Institute
  • Georgia
    • Savannah, Georgia, United States, 31405
      • Southern Retina
  • Kentucky
    • Louisville, Kentucky, United States, 40206
      • Eye Care Institute
  • Massachusetts
    • Boston, Massachusetts, United States, 02482
      • Boston Retina
  • Nevada
    • Reno, Nevada, United States, 89502
      • Sierra Eye Associates
  • Texas
    • Denison, Texas, United States, 75020
      • Texoma Retina Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Graybug Vision

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 11, 2019
• Primary Completion (ACTUAL): June 5, 2020
• Study Completion (ACTUAL): June 5, 2020

Study Registration Dates

• First Submitted: September 9, 2019
• First Submitted That Met QC Criteria: September 9, 2019
• First Posted (ACTUAL): September 11, 2019

Study Record Updates

• Last Update Posted (ACTUAL): November 22, 2021
• Last Update Submitted That Met QC Criteria: November 18, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Macular Edema
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Retinal Degeneration; Retinal Diseases; Embolism and Thrombosis; Venous Thrombosis; Thrombosis; Macular Degeneration; Macular Edema; Retinal Vein Occlusion; Edema; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Protein Kinase Inhibitors; Sunitinib
• Other Study ID Numbers: GBV-102-003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No