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

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)

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.

Study Overview

• Status: Completed
• Conditions: Neovascular Age-Related Macular Degeneration
• Intervention / Treatment: Drug: Drug: GB-102; Drug: 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 Type: Interventional
• Enrollment (Actual): 56
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Gilbert, Arizona, United States, 85296
      • Retinal Consultants AZ
    • Phoenix, Arizona, United States, 85017
      • Retinal Research Institute
  • California
    • Bakersfield, California, United States, 93309
      • California Retina Research Consultants
    • Campbell, California, United States, 95008
      • Retinal Diagnostic Center of Northern California
    • Encino, California, United States, 91436
      • The Retina Partners
    • Fullerton, California, United States, 92835
      • Retina Consultants of Orange County
    • Mountain View, California, United States, 94040
      • Northern California Retina Vitreous Associates Medical Group, Inc.
    • San Francisco, California, United States, 94109
      • West Coast Retina Medical Group, Inc.
    • Santa Barbara, California, United States, 93103
      • California Retina Consultants - CRC
    • Walnut Creek, California, United States, 94598
      • Bay Area Retina Associates
  • Florida
    • Coral Springs, Florida, United States, 32503
      • Specialty Retina Center
    • Orlando, Florida, United States, 32806-1101
      • Florida Retina Institute
    • Pensacola, Florida, United States, 32503
      • Retina Specialty Institute
    • Pinellas Park, Florida, United States, 33782
      • Eye Associates of Pinellas
  • Georgia
    • Augusta, Georgia, United States, 30909
      • Southeast Retina Center
  • Hawaii
    • 'Aiea, Hawaii, United States, 96701
      • Retina Consultants of Hawaii
  • Illinois
    • Lemont, Illinois, United States, 60439
      • University Retina and Macula
  • Iowa
    • Des Moines, Iowa, United States, 50266
      • Wolfe Eye Clinic - West Des Moines
  • Louisiana
    • West Monroe, Louisiana, United States, 71291
      • Eye Associates of Northeast Louisiana
  • Maryland
    • Hagerstown, Maryland, United States, 21740
      • Cumberland Valley Retina Consultants
    • Hagerstown, Maryland, United States, 21740
      • Mid Atlantic Retina Specialists
  • Nevada
    • Reno, Nevada, United States, 89502
      • Sierra Eye Associates
  • New York
    • Oceanside, New York, United States, 11572
      • Ophthalmic Consultants of Long Island
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Sterling Research
  • South Dakota
    • Rapid City, South Dakota, United States, 57701
      • Black Hills Regional Eye Institute
  • Texas
    • Abilene, Texas, United States, 79606
      • Retina Research Institute of Texas
    • Austin, Texas, United States, 78705
      • Retina Research Center, PLLC
    • Austin, Texas, United States, 78705
      • Austin Retina Associates
    • Plano, Texas, United States, 75093
      • Retina Specialists
    • The Woodlands, Texas, United States, 77384
      • Retina Consultants of Houston
    • Willow Park, Texas, United States, 76087
      • Strategic Clinical Research Group LLC
  • Virginia
    • Lynchburg, Virginia, United States, 24502
      • Piedmont Eye Center
  • Washington
    • Silverdale, Washington, United States, 98383
      • Retina Center NW PLLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Graybug Vision

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2019
• Primary Completion (Actual): December 15, 2020
• Study Completion (Actual): June 3, 2021

Study Registration Dates

• First Submitted: May 13, 2019
• First Submitted That Met QC Criteria: May 14, 2019
• First Posted (Actual): May 16, 2019

Study Record Updates

• Last Update Posted (Actual): January 19, 2022
• Last Update Submitted That Met QC Criteria: January 10, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Age-related macular degeneration (AMD); Choroidal neovascularization
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Protein Kinase Inhibitors; Sunitinib; Aflibercept
• Other Study ID Numbers: GBV-102-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No