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

Phase 2

Completed

• Conditions: Neovascular Age-Related Macular Degeneration
• Interventions: Drug: Aflibercept

• Registration Number: NCT03953079
• Lead Sponsor: Graybug Vision

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

Study Timeline

• Study First Submitted: 2019-05-13
• Study First Submitted QC: 2019-05-14
• Study First Posted: 2019-05-16
• Study Start: 2019-09-26
• Primary Completion: 2020-12-15
• Study Completion: 2021-06-03
• Results First Submitted: 2021-12-14
• Results First Submitted QC: 2021-12-14
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-10
• Results First Posted: 2022-01-11
• Last Update Posted: 2022-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aflibercept 2 mg	Aflibercept	Participants will receive intravitreal (IVT) aflibercept 2 mg in the study eye at Baseline, Months 2, 4, 6, 8 and 10.

Primary Outcome Measures

Name	Time	Method
Time to First Rescue Treatment	Baseline through 12 months	Kaplan-Meier estimate of the median time to first rescue treatment.

Secondary Outcome Measures

Name	Time	Method
Number of Treatments, Including Both Rescue and Scheduled Study Treatments, During the Study	Baseline through 12 months	Assessment of the number of treatments, including both rescue and scheduled study treatments, that occurred during the study
Change From Baseline in Best-corrected Visual Acuity (BCVA) (ETDRS Letter Score) at All Visits	Baseline through 12 months	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
Categorical Change From Baseline in BCVA (ETDRS Letter Score) at All Visits	Baseline through 12 months	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
Frequency of Subjects With Absence of Exudation (Intra-/Sub-retinal Fluid/Cystoid Edema) at at All Visits	Baseline through 12 months	Assessment of the frequency of subjects with absence of exudation (intra-/sub-retinal fluid/cystoid edema) at all visits
Number of Times That at Least One Rescue Criterion is Met	Baseline through 12 months	Assessment of the number of monthly intervals that at least one rescue criterion is met
Time to Fulfillment of at Least One Rescue Criterion	6 months through 12 months	Assessment of time to fulfillment of at least one rescue criterion starting at the Month 6 visit through to the Month 12 visit
Frequency of Subjects With BCVA Worse Than 20/200 (Snellen Equivalent) at All Visits	Baseline through 12 months	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.
Change From Baseline in Central Subfield Thickness (CST) (μm) at All Visits	Baseline through 12 months	CST = central subfield thickness; Assessment of change in CST (μm) measurement from baseline at all visits

Trial Locations

Locations (33)

Cumberland Valley Retina Consultants; 🇺🇸 Hagerstown, Maryland, United States

California Retina Research Consultants; 🇺🇸 Bakersfield, California, United States

Southeast Retina Center; 🇺🇸 Augusta, Georgia, United States

Sterling Research; 🇺🇸 Cincinnati, Ohio, United States

Retinal Research Institute; 🇺🇸 Phoenix, Arizona, United States

Bay Area Retina Associates; 🇺🇸 Walnut Creek, California, United States

Retina Consultants of Orange County; 🇺🇸 Fullerton, California, United States

Retinal Consultants AZ; 🇺🇸 Gilbert, Arizona, United States

The Retina Partners; 🇺🇸 Encino, California, United States

Retinal Diagnostic Center of Northern California; 🇺🇸 Campbell, California, United States

West Coast Retina Medical Group, Inc.; 🇺🇸 San Francisco, California, United States

Northern California Retina Vitreous Associates Medical Group, Inc.; 🇺🇸 Mountain View, California, United States

Specialty Retina Center; 🇺🇸 Coral Springs, Florida, United States

California Retina Consultants - CRC; 🇺🇸 Santa Barbara, California, United States

Florida Retina Institute; 🇺🇸 Orlando, Florida, United States

Eye Associates of Pinellas; 🇺🇸 Pinellas Park, Florida, United States

Retina Consultants of Hawaii; 🇺🇸 'Aiea, Hawaii, United States

University Retina and Macula; 🇺🇸 Lemont, Illinois, United States

Wolfe Eye Clinic - West Des Moines; 🇺🇸 Des Moines, Iowa, United States

Eye Associates of Northeast Louisiana; 🇺🇸 West Monroe, Louisiana, United States

Sierra Eye Associates; 🇺🇸 Reno, Nevada, United States

Mid Atlantic Retina Specialists; 🇺🇸 Hagerstown, Maryland, United States

Ophthalmic Consultants of Long Island; 🇺🇸 Oceanside, New York, United States

Black Hills Regional Eye Institute; 🇺🇸 Rapid City, South Dakota, United States

Retina Research Institute of Texas; 🇺🇸 Abilene, Texas, United States

Austin Retina Associates; 🇺🇸 Austin, Texas, United States

Retina Consultants of Houston; 🇺🇸 The Woodlands, Texas, United States

Strategic Clinical Research Group LLC; 🇺🇸 Willow Park, Texas, United States

Retina Center NW PLLC; 🇺🇸 Silverdale, Washington, United States

Retina Research Center, PLLC; 🇺🇸 Austin, Texas, United States

Piedmont Eye Center; 🇺🇸 Lynchburg, Virginia, United States

Retina Specialists; 🇺🇸 Plano, Texas, United States

Retina Specialty Institute; 🇺🇸 Pensacola, Florida, United States