A Depot Formulation of Sunitinib Malate (GB-102) Compared to Aflibercept in Subjects With Wet AMD (ALTISSIMO)
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ClinicalTrials.gov Identifier: NCT03953079 |
Recruitment Status :
Active, not recruiting
First Posted : May 16, 2019
Last Update Posted : January 19, 2021
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Tracking Information | |||||
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First Submitted Date ICMJE | May 13, 2019 | ||||
First Posted Date ICMJE | May 16, 2019 | ||||
Last Update Posted Date | January 19, 2021 | ||||
Actual Study Start Date ICMJE | September 26, 2019 | ||||
Actual Primary Completion Date | December 15, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Kaplan-Meier analysis of time to first rescue treatment [ Time Frame: Baseline through 12 months ] | ||||
Original Primary Outcome Measures ICMJE |
Kaplan-Meier analyses of the proportion of treated subjects remaining rescue-free through Month 10 [ Time Frame: Baseline through 10 months ] Assessment of the percentage of subjects remaining rescue free at Month 10
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Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | A Depot Formulation of Sunitinib Malate (GB-102) Compared to Aflibercept in Subjects With Wet AMD | ||||
Official Title ICMJE | 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) | ||||
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 |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Parallel-arm design Masking: Single (Outcomes Assessor)Masking Description: Visual examiner-masked Primary Purpose: Treatment
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Condition ICMJE | Neovascular Age-Related Macular Degeneration | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Actual Enrollment ICMJE |
56 | ||||
Original Estimated Enrollment ICMJE |
220 | ||||
Estimated Study Completion Date ICMJE | June 2021 | ||||
Actual Primary Completion Date | December 15, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 50 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03953079 | ||||
Other Study ID Numbers ICMJE | GBV-102-002 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | Graybug Vision | ||||
Study Sponsor ICMJE | Graybug Vision | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Graybug Vision | ||||
Verification Date | March 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |