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The purpose of this study is to evaluate the safety and efficacy of single and repeated intravitreal injections of GB-102 in subjects with neovascular (wet) age-related macular degeneration.
In this 2-part study, Part 1 is a multicenter, open-label, safety, tolerability, and systemic exposure evaluation to Sunitinib in escalating doses of a single IVT injection of GB-102, while Part 2 is a multicenter, double-masked, randomized (1:1:1), parallel-group, safety, and efficacy evaluation of repeated IVT injections of 2 dose levels of GB-102 compared with aflibercept.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Phase 1 - GB-102 | Experimental | Subjects will be assigned to 1 of 4 cohorts to receive a single intravitreal injection of up to 2.0 mg (50 μL) GB-102. |
|
| Experimental: Phase 2 - GB-102 | Experimental | Low dose or high dose injected every 6 months |
|
| Active Comparator: Phase 2 - Aflibercept | Active Comparator | Aflibercept 2 mg injected every 2 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GB-102 | Drug | Intravitreal injection of GB-102 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1: Occurrence of ocular and nonocular adverse events (AEs) | Number of adverse events in total and number of subjects with an adverse event | 8 months |
| Phase 2: Change from baseline in best corrected visual acuity by ETDRS | Mean change from Baseline at Day 270 (Month 9) in best corrected visual acuity (BCVA) measured by early treatment diabetic retinopathy (ETDRS) | Baseline, Month 9 |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1: Change from baseline in BCVA by ETDRS | Mean change from baseline in mean BCVA measured by early treatment diabetic retinopathy (ETDRS) method | 8 months |
| Phase 1: Change from baseline in sub-retinal thickness |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charles P. Semba, MD | Graybug Vision, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retinal Consultants of Arizona | Gilbert | Arizona | 85296 | United States | ||
| Retina-Vitreous Associates Medical Group |
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Phase 1: open-label GB-102 dose cohorts are initiated sequentially Phase 2: assignment to and initiation of cohorts occur in parallel - not completed in this study. Separate protocol (GBV-102-002) implemented for Phase 2.
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Masking is relevant to Phase 2 only
| Aflibercept | Drug | Intravitreal injection of Aflibercept. |
|
|
Mean change from baseline in sub-retinal thickness (microns) by spectral domain - optical coherence tomography (SD-OCT)
| 8 months |
| Phase 1: Change from baseline in retinal fluid by SD-OCT | Assessment of retinal fluid by SD-OCT | 8 months |
| Phase 1: Change from baseline in total lesion area by FA/CFP | Lesion area (total) by fluorescein angiography/color fundus photography (FA/CFP) | 8 months |
| Phase 1: Change from baseline in CNV lesion area by FA/CFP | CNV lesion area by FA/CFP | 8 months |
| Phase 1: Change from baseline in fluorescein leakage area by FA/CFP | Area of fluorescein leakage by FA/CFP | 8 months |
| Phase 1: Rescue medication | Proportion of subjects receiving rescue medication and median time to rescue medication | 8 months |
| Phase 1: Systemic exposure to sunitinib measured in plasma level | Plasma levels of sunitinib (ng/mL) | 8 months |
| Phase 1: Change from baseline in sub retinal hyper reflective material (SHRM) height | Subretinal hyper reflective material (SHRM) height | 8 months |
| Phase 2: Proportion of subjects with absence of retinal fluid by SD-OCT | Assessment of retinal fluid by SD-OCT | 12 months |
| Phase 2: Proportion of subjects with < 15 BCVA letter loss by ETDRS | Proportion of subjects with < 15 letters lost in BCVA measured by ETDRS method, baseline comparison to assessments at months 1-12 | 12 months |
| Phase 2: Proportion of subjects with ≥ 15 BCVA letters gained by ETDRS | Proportion of subjects with ≥ 15 letters gained in BCVA measured by ETDRS method, baseline comparison to assessments at months 1-12 | 12 months |
| Phase 2: Occurrence of ocular and nonocular adverse events (AEs) | Number of adverse events in total and number of subjects with an adverse event | 12 months |
| Phase 2: Change from baseline in BCVA by ETDRS | Mean change from baseline in mean BCVA measured by early treatment | 12 months |
| Phase 2: Systemic exposure to sunitinib measured in plasma level | Plasma levels of sunitinib (ng/mL) | 12 months |
| Phase 2: Change from baseline in sub-retinal thickness | Mean change from baseline in sub-retinal thickness (microns) by SD-OCT | 12 months |
| Phase 2: Rescue medication | Proportion of subjects receiving rescue medication and median time to rescue medication | 12 months |
| Beverly Hills |
| California |
| 90211 |
| United States |
| Midwest Eye Institute | Indianapolis | Indiana | 46290 | United States |
| Ophthalmic Consultants of Long Island | Lynbrook | New York | 11563 | United States |
| Retina Research Institute of Texas | Abilene | Texas | 79606 | United States |
| Texas Retina Associates | Arlington | Texas | 76012 | United States |
| Retina Research Center, PLLC | Austin | Texas | 78705 | United States |
| Medical Center Ophthalmology Associates | San Antonio | Texas | 78240 | United States |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D020256 | Choroidal Neovascularization |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D015862 | Choroid Diseases |
| D014603 | Uveal Diseases |
| D009389 | Neovascularization, Pathologic |
| D008679 | Metaplasia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077210 | Sunitinib |
| C533178 | aflibercept |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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