A Depot Formulation of Sunitinib Malate (GB-102) Compared to Aflibercept in Subjects With Wet AMD

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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A Phase 2b Multicenter Dose-Ranging Study Evaluating the Safety and Efficacy of Sunitinib Malate Depot Formulation (GB-102) Compared to Aflibercept in Subjects With Neovascular (Wet) Age-related Macular Degeneration (ALTISSIMO Study)

Conditions
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Neovascular Age-Related Macular Degeneration

Intervention / Treatment
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* Drug: Drug: GB-102
* Drug: Aflibercept


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel-arm design
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GB-102 1 mg/1 mg<br>Participants will receive intravitreal (IVT) GB-102 1 mg in the study eye at Baseline and Month 6 and sham at Months 2, 4, 8 and 10. | Drug: Drug: GB-102<br>* Intravitreal injection of GB-102<br>* Other names: Sunitinib malate;|
| Experimental: GB-102 2 mg/1 mg<br>Participants will receive intravitreal (IVT) GB-102 2 mg in the study eye at Baseline, intravitreal (IVT) GB-102 1 mg at Month 6 and sham at Months 2, 4, 8 and 10. | Drug: Drug: GB-102<br>* Intravitreal injection of GB-102<br>* Other names: Sunitinib malate;|
| Active Comparator: Aflibercept 2 mg<br>Participants will receive intravitreal (IVT) aflibercept 2 mg in the study eye at Baseline, Months 2, 4, 6, 8 and 10. | Drug: Aflibercept<br>* Intravitreal injection of aflibercept (2 mg dose)<br>* Other names: Eylea;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to First Rescue Treatment | Kaplan-Meier estimate of the median time to first rescue treatment. | Baseline through 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | 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 | Baseline through 12 months | 
| 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. | 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 | 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 | Baseline through 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Age-related macular degeneration (AMD), Choroidal neovascularization