A Study to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Participants With Diabetic Macular Edema (DME) (GLIMMER)
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ClinicalTrials.gov Identifier: NCT04603937 |
Recruitment Status :
Terminated
(Study did not meet primary endpoint)
First Posted : October 27, 2020
Last Update Posted : October 2, 2023
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Sponsor:
Kodiak Sciences Inc
Information provided by (Responsible Party):
Kodiak Sciences Inc
Tracking Information | |||||
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First Submitted Date ICMJE | October 21, 2020 | ||||
First Posted Date ICMJE | October 27, 2020 | ||||
Last Update Posted Date | October 2, 2023 | ||||
Actual Study Start Date ICMJE | September 30, 2020 | ||||
Actual Primary Completion Date | April 27, 2023 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Non-inferiority of KSI-301 to Aflibercept measured by changes in BCVA. [ Time Frame: Day 1 to Year 1 ] Demonstrate that KSI-301 5 mg is non-inferior to aflibercept 2 mg with respect to mean change in best corrected visual acuity (BCVA).
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | A Study to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Participants With Diabetic Macular Edema (DME) | ||||
Official Title ICMJE | A Prospective, Randomized, Double-masked, Active Comparator-controlled, Multi-center, Two-arm, Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 Compared With Intravitreal Aflibercept in Participants With Visual Impairment Secondary to Treatment-naïve Diabetic Macular Edema (DME) | ||||
Brief Summary | This Phase 3 study will evaluate the efficacy, durability, and safety of KSI-301 compared to aflibercept in participants with treatment-naïve DME. | ||||
Detailed Description | This is a Phase 3, prospective, randomized, double-masked, two-arm, multi-center non-inferiority study evaluating the efficacy and safety of repeated intravitreal dosing of KSI-301 5 mg in participants with treatment-naïve DME. The primary endpoint will be assessed at Year 1; additional secondary endpoints for efficacy will be assessed at Years 1 and 2. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 3 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Participants will be randomized 1:1 into one of two treatment arms: KSI-301 or aflibercept. Masking: Triple (Participant, Care Provider, Outcomes Assessor)Masking Description: For masking purposes, sham injections will be administered at every monthly visit if an active treatment is not administered. To preserve masking, two investigators are required for this study. The masked Investigator will be responsible for the examinations and safety assessments. The unmasked Investigator will perform the injections and post-treatment assessments. Primary Purpose: Treatment
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Condition ICMJE | Diabetic Macular Edema | ||||
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 | Terminated | ||||
Actual Enrollment ICMJE |
459 | ||||
Original Estimated Enrollment ICMJE |
450 | ||||
Actual Study Completion Date ICMJE | August 31, 2023 | ||||
Actual Primary Completion Date | April 27, 2023 (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 | 18 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 | Czechia, France, Hungary, Israel, Italy, Poland, Puerto Rico, United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04603937 | ||||
Other Study ID Numbers ICMJE | KS301P105 2020-001063-82 ( EudraCT Number ) |
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Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Kodiak Sciences Inc | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Kodiak Sciences Inc | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Kodiak Sciences Inc | ||||
Verification Date | September 2023 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |