Back to resultsA Depot Formulation of Sunitinib Malate (GB-102) in Subjects With Diabetic Macular Edema and Retinal Vein Occlusion
Primary Purpose
Diabetic Macular Edema, Retina Vein Occlusion
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
GB-102
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Macular Edema focused on measuring Macular Edema
Eligibility Criteria
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
Sites / Locations
- Retinal Research Institute
- Southern Retina
- Eye Care Institute
- Boston Retina
- Sierra Eye Associates
- Texoma Retina Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
GB-102 Dose 1 (1 mg)
GB-102 Dose 2 (2 mg)
Arm Description
Participants will receive intravitreal (IVT) GB-102 (1 mg) in the study eye at Baseline.
Participants will receive intravitreal (IVT) GB-102 (2 mg) in the study eye at Baseline.
Outcomes
Primary Outcome Measures
Occurrence of Adverse Events (AEs) Across All Study Visits
Number of subjects with an adverse event across all study visits
Secondary Outcome Measures
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
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
Time to Rescue Treatment
Assessment of time to rescue treatment over 6 months of treatment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04085341
Brief Title
A Depot Formulation of Sunitinib Malate (GB-102) in Subjects With Diabetic Macular Edema and Retinal Vein Occlusion
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)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
September 11, 2019 (Actual)
Primary Completion Date
June 5, 2020 (Actual)
Study Completion Date
June 5, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Graybug Vision
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema, Retina Vein Occlusion
Keywords
Macular Edema
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Parallel-arm design
Masking
None (Open Label)
Masking Description
Open-label study design
Allocation
Non-Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GB-102 Dose 1 (1 mg)
Arm Type
Experimental
Arm Description
Participants will receive intravitreal (IVT) GB-102 (1 mg) in the study eye at Baseline.
Arm Title
GB-102 Dose 2 (2 mg)
Arm Type
Experimental
Arm Description
Participants will receive intravitreal (IVT) GB-102 (2 mg) in the study eye at Baseline.
Intervention Type
Drug
Intervention Name(s)
GB-102
Other Intervention Name(s)
Sunitinib malate
Intervention Description
Intravitreal injection of GB-102
Primary Outcome Measure Information:
Title
Occurrence of Adverse Events (AEs) Across All Study Visits
Description
Number of subjects with an adverse event across all study visits
Time Frame
Baseline through Month 6
Secondary Outcome Measure Information:
Title
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) (ETDRS) at All Study Visits
Description
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
Time Frame
Baseline to Month 6
Title
Mean Change From Baseline in Central Subfield Thickness (CST) (SD-OCT) at All Study Visits
Description
CST = central subfield thickness
SD-OCT = spectral domain-optical coherence tomography
Assessment of change in CST (μm) measurement from baseline at all visits
Time Frame
Baseline to Month 6
Title
Time to Rescue Treatment
Description
Assessment of time to rescue treatment over 6 months of treatment
Time Frame
Baseline through Month 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chief Medical Officer
Organizational Affiliation
Graybug Vision, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Retinal Research Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85053
Country
United States
Facility Name
Southern Retina
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31405
Country
United States
Facility Name
Eye Care Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40206
Country
United States
Facility Name
Boston Retina
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02482
Country
United States
Facility Name
Sierra Eye Associates
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Facility Name
Texoma Retina Center
City
Denison
State/Province
Texas
ZIP/Postal Code
75020
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Depot Formulation of Sunitinib Malate (GB-102) in Subjects With Diabetic Macular Edema and Retinal Vein Occlusion
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