A Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 Compared With Intravitreal Aflibercept in Participants With Neovascular (Wet) Age-related Macular Degeneration (wAMD) (DAYLIGHT)
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|ClinicalTrials.gov Identifier: NCT04964089|
Recruitment Status : Active, not recruiting
First Posted : July 15, 2021
Last Update Posted : June 6, 2022
|Condition or disease||Intervention/treatment||Phase|
|Wet Age-related Macular Degeneration||Drug: KSI-301 Drug: Aflibercept Other: Sham Procedure||Phase 3|
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 visual impairment due to treatment-naïve neovascular (wet) age-related macular degeneration (wAMD)
The primary endpoint will be assessed as an average of Weeks 40, 44, and 48; additional secondary endpoints for efficacy will be assessed by visit over time
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||557 participants|
|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.|
|Official Title:||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 Neovascular (Wet) Age-related Macular Degeneration (wAMD)|
|Actual Study Start Date :||June 15, 2021|
|Estimated Primary Completion Date :||March 2023|
|Estimated Study Completion Date :||April 2023|
Experimental: KSI-301 (Treatment Group A)
Intravitreal injection of KSI-301 (5 mg) at Day 1 once every 4 weeks via intravitreal injection through Week 44.
Active Comparator: Aflibercept (Treatment Group B)
Intravitreal injection of aflibercept (2 mg) once every 4 weeks for 3 monthly doses followed by intravitreal injection of aflibercept (2 mg) once every 8 weeks from Week 16 to Week 44. Sham injections will be administered at each monthly visit where an active treatment is not administered.
Other Name: Eylea
Other: Sham Procedure
The sham is a procedure that mimics an intravitreal injection. It involves pressing the blunt end of an empty syringe (without a needle) against the anesthetized eye. It will be administered to participants in both treatments arms at applicable visits to maintain masking.
- Non-inferiority of KSI-301 to aflibercept measured by changes in BCVA. [ Time Frame: Day 1 to Week 48 ]Demonstrate that KSI-301 5 mg is non-inferior to aflibercept 2 mg with respect to mean change in best-corrected visual acuity (BCVA).
- Efficacy of KSI-301 5 mg compared to aflibercept 2 mg based on changes in BCVA [ Time Frame: Day 1 to Week 48 ]Change from baseline in best corrected visual acuity (BCVA) between the two treatment arms.
- Efficacy of KSI-301 5 mg compared to aflibercept 2 mg based on OCT-CST [ Time Frame: Day 1 to Week 48 ]Change from baseline in central subfield thickness (CST) between the two treatment arms.
- Safety and tolerability of KSI-301 5 mg compared to aflibercept 2 mg based on the number of ocular and systemic adverse events [ Time Frame: Day 1 to Week 52 ]Incidence of ocular and systemic adverse events between the two treatment arms.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04964089
|Study Director:||Pablo Velazquez-Martin, MD||Kodiak Sciences Inc|