Neovascular Age-Related Macular Degeneration
Conditions
Keywords
Age-related macular degeneration, Choroidal neovascularization
Brief summary
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.
Detailed description
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.
Interventions
DRUGGB-102
Intravitreal injection of GB-102
DRUGAflibercept
Intravitreal injection of Aflibercept.
Sponsors
Graybug Vision
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
Masking is relevant to Phase 2 only
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. Males or females of any race, ≥ 50 years of age 2. Presence of an active CNV lesion secondary to AMD treated with at least 3 monthly injections of an anti-VEGF agent (aflibercept, bevacizumab, or ranibizumab) 3. Evidence of increased vascular permeability and/or loss of visual acuity Key
Exclusion criteria
1. 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 2. Uncontrolled hypertension, diabetes mellitus, IOP, hypothyroidism, or hyperthyroidism 3. Chronic renal disease 4. Abnormal liver function 5. Women who are pregnant or lactating
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase 1: Occurrence of ocular and nonocular adverse events (AEs) | 8 months | Number of adverse events in total and number of subjects with an adverse event |
| Phase 2: Change from baseline in best corrected visual acuity by ETDRS | Baseline, Month 9 | Mean change from Baseline at Day 270 (Month 9) in best corrected visual acuity (BCVA) measured by early treatment diabetic retinopathy (ETDRS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Phase 1: Change from baseline in fluorescein leakage area by FA/CFP | 8 months | Area of fluorescein leakage by FA/CFP |
| Phase 1: Change from baseline in sub-retinal thickness | 8 months | Mean change from baseline in sub-retinal thickness (microns) by spectral domain - optical coherence tomography (SD-OCT) |
| Phase 1: Change from baseline in retinal fluid by SD-OCT | 8 months | Assessment of retinal fluid by SD-OCT |
| Phase 1: Change from baseline in BCVA by ETDRS | 8 months | Mean change from baseline in mean BCVA measured by early treatment diabetic retinopathy (ETDRS) method |
| Phase 1: Rescue medication | 8 months | Proportion of subjects receiving rescue medication and median time to rescue medication |
| Phase 1: Systemic exposure to sunitinib measured in plasma level | 8 months | Plasma levels of sunitinib (ng/mL) |
| Phase 1: Change from baseline in sub retinal hyper reflective material (SHRM) height | 8 months | Subretinal hyper reflective material (SHRM) height |
| Phase 1: Change from baseline in total lesion area by FA/CFP | 8 months | Lesion area (total) by fluorescein angiography/color fundus photography (FA/CFP) |
| Phase 2: Proportion of subjects with < 15 BCVA letter loss by ETDRS | 12 months | Proportion of subjects with \< 15 letters lost in BCVA measured by ETDRS method, baseline comparison to assessments at months 1-12 |
| Phase 2: Proportion of subjects with ≥ 15 BCVA letters gained by ETDRS | 12 months | Proportion of subjects with ≥ 15 letters gained in BCVA measured by ETDRS method, baseline comparison to assessments at months 1-12 |
| Phase 2: Occurrence of ocular and nonocular adverse events (AEs) | 12 months | Number of adverse events in total and number of subjects with an adverse event |
| Phase 2: Change from baseline in BCVA by ETDRS | 12 months | Mean change from baseline in mean BCVA measured by early treatment |
| Phase 2: Systemic exposure to sunitinib measured in plasma level | 12 months | Plasma levels of sunitinib (ng/mL) |
| Phase 2: Change from baseline in sub-retinal thickness | 12 months | Mean change from baseline in sub-retinal thickness (microns) by SD-OCT |
| Phase 2: Rescue medication | 12 months | Proportion of subjects receiving rescue medication and median time to rescue medication |
| Phase 2: Proportion of subjects with absence of retinal fluid by SD-OCT | 12 months | Assessment of retinal fluid by SD-OCT |
| Phase 1: Change from baseline in CNV lesion area by FA/CFP | 8 months | CNV lesion area by FA/CFP |
Countries
United States
Outcome results
None listed