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)
1 other identifier
interventional
56
1 country
33
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Sep 2019
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 13, 2019
CompletedFirst Posted
Study publicly available on registry
May 16, 2019
CompletedStudy Start
First participant enrolled
September 26, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 3, 2021
CompletedResults Posted
Study results publicly available
January 11, 2022
CompletedJanuary 19, 2022
January 1, 2022
1.2 years
May 13, 2019
December 14, 2021
January 10, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to First Rescue Treatment
Kaplan-Meier estimate of the median time to first rescue treatment.
Baseline through 12 months
Secondary Outcomes (8)
Time to Fulfillment of at Least One Rescue Criterion
6 months through 12 months
Number of Times 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
Baseline through 12 months
Change From Baseline in Best-corrected Visual Acuity (BCVA) (ETDRS Letter Score) at All Visits
Baseline through 12 months
Categorical Change From Baseline in BCVA (ETDRS Letter Score) at All Visits
Baseline through 12 months
- +3 more secondary outcomes
Study Arms (3)
GB-102 1 mg/1 mg
EXPERIMENTALParticipants 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.
GB-102 2 mg/1 mg
EXPERIMENTALParticipants 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.
Aflibercept 2 mg
ACTIVE COMPARATORParticipants will receive intravitreal (IVT) aflibercept 2 mg in the study eye at Baseline, Months 2, 4, 6, 8 and 10.
Interventions
Intravitreal injection of GB-102
Intravitreal injection of aflibercept (2 mg dose)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Graybug Visionlead
Study Sites (33)
Retinal Consultants AZ
Gilbert, Arizona, 85296, United States
Retinal Research Institute
Phoenix, Arizona, 85017, United States
California Retina Research Consultants
Bakersfield, California, 93309, United States
Retinal Diagnostic Center of Northern California
Campbell, California, 95008, United States
The Retina Partners
Encino, California, 91436, United States
Retina Consultants of Orange County
Fullerton, California, 92835, United States
Northern California Retina Vitreous Associates Medical Group, Inc.
Mountain View, California, 94040, United States
West Coast Retina Medical Group, Inc.
San Francisco, California, 94109, United States
California Retina Consultants - CRC
Santa Barbara, California, 93103, United States
Bay Area Retina Associates
Walnut Creek, California, 94598, United States
Specialty Retina Center
Coral Springs, Florida, 32503, United States
Florida Retina Institute
Orlando, Florida, 32806-1101, United States
Retina Specialty Institute
Pensacola, Florida, 32503, United States
Eye Associates of Pinellas
Pinellas Park, Florida, 33782, United States
Southeast Retina Center
Augusta, Georgia, 30909, United States
Retina Consultants of Hawaii
‘Aiea, Hawaii, 96701, United States
University Retina and Macula
Lemont, Illinois, 60439, United States
Wolfe Eye Clinic - West Des Moines
Des Moines, Iowa, 50266, United States
Eye Associates of Northeast Louisiana
West Monroe, Louisiana, 71291, United States
Cumberland Valley Retina Consultants
Hagerstown, Maryland, 21740, United States
Mid Atlantic Retina Specialists
Hagerstown, Maryland, 21740, United States
Sierra Eye Associates
Reno, Nevada, 89502, United States
Ophthalmic Consultants of Long Island
Oceanside, New York, 11572, United States
Sterling Research
Cincinnati, Ohio, 45219, United States
Black Hills Regional Eye Institute
Rapid City, South Dakota, 57701, United States
Retina Research Institute of Texas
Abilene, Texas, 79606, United States
Austin Retina Associates
Austin, Texas, 78705, United States
Retina Research Center, PLLC
Austin, Texas, 78705, United States
Retina Specialists
Plano, Texas, 75093, United States
Retina Consultants of Houston
The Woodlands, Texas, 77384, United States
Strategic Clinical Research Group LLC
Willow Park, Texas, 76087, United States
Piedmont Eye Center
Lynchburg, Virginia, 24502, United States
Retina Center NW PLLC
Silverdale, Washington, 98383, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Small sample size hinders the ability to compare groups statistically.
Results Point of Contact
- Title
- Executive Director, Biostatistics
- Organization
- Graybug Vision
Study Officials
- STUDY DIRECTOR
Chief Medical Officer
Graybug Vision, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Visual examiner-masked
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 13, 2019
First Posted
May 16, 2019
Study Start
September 26, 2019
Primary Completion
December 15, 2020
Study Completion
June 3, 2021
Last Updated
January 19, 2022
Results First Posted
January 11, 2022
Record last verified: 2022-01