Phase 2b, multicenter, visual examiner-masked, randomized active-controlled, parallel-arm design study to evaluate the safety and duration of repeated IVT injections of 3 dose levels of GB-102 compared with aflibercept.
Phase 2b, multicenter, visual examiner-masked, randomized active-controlled, parallel-arm design study to evaluate the safety and duration of the effect of GB-102, as measured by time to first rescue treatment across multiple dose levels of GB-102 administered every 6 months as compared to intravitreal (IVT) aflibercept administered every 2 months in subjects with neovascular (wet) age-related macular degeneration who have received prior induction with anti-vascular endothelial growth factor (VEGF) Extension Study: To monitor the safety and duration of effect of IVT GB-102 administered every 6 months compared to IVT aflibercept administered every 2 months in subjects in ALTISSIMO (Core Study) who complete all study visits through Month 12 (Day 360) and who do not require/receive rescue treatment at the Month 12 (Day 360) final study visit
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
56
Intravitreal injection of GB-102
Intravitreal injection of aflibercept (2 mg dose)
Time to First Rescue Treatment
Kaplan-Meier estimate of the median time to first rescue treatment.
Time frame: Baseline through 12 months
Time to Fulfillment of at Least One Rescue Criterion
Assessment of time to fulfillment of at least one rescue criterion starting at the Month 6 visit through to the Month 12 visit
Time frame: 6 months through 12 months
Number of Times That at Least One Rescue Criterion is Met
Assessment of the number of monthly intervals that at least one rescue criterion is met
Time frame: Baseline through 12 months
Number of Treatments, Including Both Rescue and Scheduled Study Treatments, During the Study
Assessment of the number of treatments, including both rescue and scheduled study treatments, that occurred during the study
Time frame: Baseline through 12 months
Change From Baseline in Best-corrected Visual Acuity (BCVA) (ETDRS Letter Score) at All Visits
BCVA = best corrected visual acuity; ETDRS = early treatment of diabetic retinopathy BCVA ETDRS range = 0 (worst) to 100 (best) Assessment of change in BCVA (ETDRS letter score) from baseline at all visits
Time frame: Baseline through 12 months
Categorical Change From Baseline in BCVA (ETDRS Letter Score) at All Visits
BCVA = best corrected visual acuity; ETDRS = early treatment of diabetic retinopathy BCVA ETDRS range = 0 (worst) to 100 (best) Assessment of categorical change in BCVA (ETDRS letter score) from baseline at all visits
Time frame: Baseline through 12 months
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Frequency of Subjects With BCVA Worse Than 20/200 (Snellen Equivalent) at All Visits
Assessment of the frequency of subjects with BCVA worse than 20/200 (Snellen equivalent) at all visits A vision score of 20/20 is considered normal. A vision score of 20/200 is considered legally blind.
Time frame: Baseline through 12 months
Change From Baseline in Central Subfield Thickness (CST) (μm) at All Visits
CST = central subfield thickness Assessment of change in CST (μm) measurement from baseline at all visits
Time frame: Baseline through 12 months
Frequency of Subjects With Absence of Exudation (Intra-/Sub-retinal Fluid/Cystoid Edema) at at All Visits
Assessment of the frequency of subjects with absence of exudation (intra-/sub-retinal fluid/cystoid edema) at all visits
Time frame: Baseline through 12 months