Diabetic Macular Edema, Retina Vein Occlusion
Conditions
Keywords
Macular Edema
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)
Interventions
DRUGGB-102
Intravitreal injection of GB-102
Sponsors
Graybug Vision
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Open-label study design
Intervention model description
Parallel-arm design
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of Adverse Events (AEs) Across All Study Visits | Baseline through Month 6 | Number of subjects with an adverse event across all study visits |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) (ETDRS) at All Study Visits | Baseline to Month 6 | 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 | Baseline to Month 6 | 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 | Baseline through Month 6 | Assessment of time to rescue treatment over 6 months of treatment |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| GB-102 Dose 1 (1 mg) Participants will receive intravitreal (IVT) GB-102 (1 mg) in the study eye at Baseline.
GB-102: Intravitreal injection of GB-102 | 10 |
| GB-102 Dose 2 (2 mg) Participants will receive intravitreal (IVT) GB-102 (2 mg) in the study eye at Baseline.
GB-102: Intravitreal injection of GB-102 | 11 |
| Total | 21 |
Baseline characteristics
| Characteristic | GB-102 Dose 1 (1 mg) | Total | GB-102 Dose 2 (2 mg) |
|---|---|---|---|
| Age, Continuous | 64.6 years STANDARD_DEVIATION 13.83 | 64.9 years STANDARD_DEVIATION 11.88 | 65.1 years STANDARD_DEVIATION 10.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 2 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants | 19 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 10 Participants | 19 Participants | 9 Participants |
| Region of Enrollment United States | 10 participants | 21 participants | 11 participants |
| Sex: Female, Male Female | 3 Participants | 7 Participants | 4 Participants |
| Sex: Female, Male Male | 7 Participants | 14 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 11 |
| other Total, other adverse events | 7 / 10 | 10 / 11 |
| serious Total, serious adverse events | 1 / 10 | 2 / 11 |
Outcome results
Primary
Occurrence of Adverse Events (AEs) Across All Study Visits
Number of subjects with an adverse event across all study visits
Time frame: Baseline through Month 6
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GB-102 Dose 1 (1 mg) | Occurrence of Adverse Events (AEs) Across All Study Visits | 7 Participants |
| GB-102 Dose 2 (2 mg) | Occurrence of Adverse Events (AEs) Across All Study Visits | 10 Participants |
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
Time frame: Baseline to Month 6
| Arm | Measure | Value (MEAN) |
|---|---|---|
| GB-102 Dose 1 (1 mg) | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) (ETDRS) at All Study Visits | -10.4 letters |
| GB-102 Dose 2 (2 mg) | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) (ETDRS) at All Study Visits | -16.7 letters |
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
Time frame: Baseline to Month 6
| Arm | Measure | Value (MEAN) |
|---|---|---|
| GB-102 Dose 1 (1 mg) | Mean Change From Baseline in Central Subfield Thickness (CST) (SD-OCT) at All Study Visits | 131.0 micrometers |
| GB-102 Dose 2 (2 mg) | Mean Change From Baseline in Central Subfield Thickness (CST) (SD-OCT) at All Study Visits | -37.4 micrometers |
Secondary
Time to Rescue Treatment
Assessment of time to rescue treatment over 6 months of treatment
Time frame: Baseline through Month 6
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| GB-102 Dose 1 (1 mg) | Time to Rescue Treatment | 90 days |
| GB-102 Dose 2 (2 mg) | Time to Rescue Treatment | 120 days |