Clinical trial NCT03953079: A Depot Formulation of Sunitinib Malate (GB-102) Compared to Aflibercept in Subjects With Wet AMD
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neovascular Age-Related Macular Degeneration
Keywords: Age-related macular degeneration (AMD)
Choroidal neovascularization
Lead sponsor: Graybug Vision
Sponsor class: INDUSTRY
First posted: 2019-05-16
Enrollment: 56
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel-arm design
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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

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

Primary outcomes:
measure: Time to First Rescue Treatment
timeFrame: Baseline through 12 months
Secondary outcomes:
measure: Time to Fulfillment of at Least One Rescue Criterion
timeFrame: 6 months through 12 months
measure: Number of Times That at Least One Rescue Criterion is Met
timeFrame: Baseline through 12 months
measure: Number of Treatments, Including Both Rescue and Scheduled Study Treatments, During the Study
timeFrame: Baseline through 12 months
measure: Change From Baseline in Best-corrected Visual Acuity (BCVA) (ETDRS Letter Score) at All Visits
timeFrame: Baseline through 12 months
measure: Categorical Change From Baseline in BCVA (ETDRS Letter Score) at All Visits
timeFrame: Baseline through 12 months
measure: Frequency of Subjects With BCVA Worse Than 20/200 (Snellen Equivalent) at All Visits
timeFrame: Baseline through 12 months
measure: Change From Baseline in Central Subfield Thickness (CST) (μm) at All Visits
timeFrame: Baseline through 12 months
measure: Frequency of Subjects With Absence of Exudation (Intra-/Sub-retinal Fluid/Cystoid Edema) at at All Visits
timeFrame: Baseline through 12 months
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Retinal Consultants AZ
state: Arizona
city: Phoenix
country: United States
facility: Retinal Research Institute
state: Arizona
city: Bakersfield
country: United States
facility: California Retina Research Consultants
state: California
city: Campbell
country: United States
facility: Retinal Diagnostic Center of Northern California
state: California
city: Encino
country: United States
facility: The Retina Partners
state: California
city: Fullerton
country: United States
facility: Retina Consultants of Orange County
state: California
city: Mountain View
country: United States
facility: Northern California Retina Vitreous Associates Medical Group, Inc.
state: California
city: San Francisco
country: United States
facility: West Coast Retina Medical Group, Inc.
state: California
city: Santa Barbara
country: United States
facility: California Retina Consultants - CRC
state: California
city: Walnut Creek
country: United States
facility: Bay Area Retina Associates
state: California
city: Coral Springs
country: United States
facility: Specialty Retina Center
state: Florida
city: Orlando
country: United States
facility: Florida Retina Institute
state: Florida
city: Pensacola
country: United States
facility: Retina Specialty Institute
state: Florida
city: Pinellas Park
country: United States
facility: Eye Associates of Pinellas
state: Florida
city: Augusta
country: United States
facility: Southeast Retina Center
state: Georgia
city: 'Aiea
country: United States
facility: Retina Consultants of Hawaii
state: Hawaii
city: Lemont
country: United States
facility: University Retina and Macula
state: Illinois
city: Des Moines
country: United States
facility: Wolfe Eye Clinic - West Des Moines
state: Iowa
city: West Monroe
country: United States
facility: Eye Associates of Northeast Louisiana
state: Louisiana
city: Hagerstown
country: United States
facility: Cumberland Valley Retina Consultants
state: Maryland
city: Hagerstown
country: United States
facility: Mid Atlantic Retina Specialists
state: Maryland
city: Reno
country: United States
facility: Sierra Eye Associates
state: Nevada
city: Oceanside
country: United States
facility: Ophthalmic Consultants of Long Island
state: New York
city: Cincinnati
country: United States
facility: Sterling Research
state: Ohio
city: Rapid City
country: United States
facility: Black Hills Regional Eye Institute
state: South Dakota
city: Abilene
country: United States
facility: Retina Research Institute of Texas
state: Texas
city: Austin
country: United States
facility: Austin Retina Associates
state: Texas
city: Austin
country: United States
facility: Retina Research Center, PLLC
state: Texas
city: Plano
country: United States
facility: Retina Specialists
state: Texas
city: The Woodlands
country: United States
facility: Retina Consultants of Houston
state: Texas
city: Willow Park
country: United States
facility: Strategic Clinical Research Group LLC
state: Texas
city: Lynchburg
country: United States
facility: Piedmont Eye Center
state: Virginia
city: Silverdale
country: United States
facility: Retina Center NW PLLC
state: Washington
Study officials:
affiliation: Graybug Vision, Inc.
name: Chief Medical Officer
role: STUDY_DIRECTOR
References: