Phase 2
Completed N=56
A Depot Formulation of Sunitinib Malate (GB-102) Compared to Aflibercept in Subjects With Wet AMD
Source: ClinicalTrials.gov NCT03953079 ↗Enrolled (actual)
56
Serious AEs
12.5%
Results posted
Jan 2022
Primary outcomePrimary: Time to First Rescue Treatment — 5; 4; NA months
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to First Rescue Treatment |
5; 4; NA | — |
| SECONDARY Time to Fulfillment of at Least One Rescue Criterion |
1.5; 2; NA | — |
| SECONDARY Number of Times That at Least One Rescue Criterion is Met |
5.1; 6.1; 1.1 | — |
| SECONDARY Number of Treatments, Including Both Rescue and Scheduled Study Treatments, During the Study |
4; 4; 6 | — |
| SECONDARY Change From Baseline in Best-corrected Visual Acuity (BCVA) (ETDRS Letter Score) at All Visits |
-7.4; -5.1; 1.8 | — |
| SECONDARY Categorical Change From Baseline in BCVA (ETDRS Letter Score) at All Visits |
7; 4; 0; 3; 2; 2 | — |
| SECONDARY Frequency of Subjects With BCVA Worse Than 20/200 (Snellen Equivalent) at All Visits |
3; 1; 0 | — |
| SECONDARY Change From Baseline in Central Subfield Thickness (CST) (μm) at All Visits |
41.7; 27.2; 7.8 | — |
| SECONDARY Frequency of Subjects With Absence of Exudation (Intra-/Sub-retinal Fluid/Cystoid Edema) at at All Visits |
2; 3; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Males or females ≥ 50 years of age
- Presence of a choroidal neovascularization (CNV) lesion secondary to AMD treated with at least 3 prior intravitreal (IVT) injections of an anti-vascular endothelial growth factor (VEGF) agent (aflibercept, bevacizumab, or ranibizumab).
- Demonstrated response to prior anti-VEGF treatment since diagnosis
- Best-corrected visual acuity (BCVA) of 35 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 intraocular pressure (IOP)
- Chronic renal disease
- Abnormal liver function
- Women who are pregnant or lactating
Data sourced from ClinicalTrials.gov (NCT03953079). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.