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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)
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.
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
Age
50 - No limit years
Sex
ALL
Healthy Volunteers
No
Retinal Consultants AZ
Gilbert, Arizona, United States
Retinal Research Institute
Phoenix, Arizona, United States
California Retina Research Consultants
Bakersfield, California, United States
Retinal Diagnostic Center of Northern California
Campbell, California, United States
The Retina Partners
Encino, California, United States
Retina Consultants of Orange County
Fullerton, California, United States
Northern California Retina Vitreous Associates Medical Group, Inc.
Mountain View, California, United States
West Coast Retina Medical Group, Inc.
San Francisco, California, United States
California Retina Consultants - CRC
Santa Barbara, California, United States
Bay Area Retina Associates
Walnut Creek, California, United States
Start Date
September 26, 2019
Primary Completion Date
December 15, 2020
Completion Date
June 3, 2021
Last Updated
January 19, 2022
56
ACTUAL participants
Drug: GB-102
DRUG
Aflibercept
DRUG
Lead Sponsor
Graybug Vision
NCT05562947
NCT05904028
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06213038