A Trial to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Participants With Diabetic Macular Edema (DME)
Part of paid clinical trials in La Jolla, California.
- Sponsor
- Kodiak Sciences Inc
- Study ID
- NCT04611152
- Phase
- PHASE3
- Status
- Terminated
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- KSI-301 — DRUGIntravitreal Injection
- Aflibercept — DRUGIntravitreal Injection
- Sham Procedure — OTHERThe 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.
Study Details
This Phase 3 study will evaluate the efficacy, durability, and safety of KSI-301 compared to aflibercept in participants with treatment-naïve DME.
Key Dates
- Start date
- Sep 30, 2020
- Status verified
- Aug 2024
- Primary completion
- May 11, 2023
- Completion
- Aug 31, 2023
Study Design
- Enrollment
- 460 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: KSI-301 (Arm A)Intravitreal injection of KSI-301 (5 mg) once every 4 weeks for 3 monthly doses followed by an individualized dosing regimen (every 8 to 24 weeks) via intravitreal injection from Week 16 to Week 100.
- Active Comparator: Aflibercept (Arm B)Intravitreal injection of aflibercept (2 mg) once every 4 weeks for 5 monthly doses followed by aflibercept (2 mg) once every 8 weeks via intravitreal injection from Week 24 to 100.
Primary Outcome Measure
Mean Change in BCVA [ Time Frame: Day 1 to Week 64 ]
Locations (48)
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UCSD Jacobs Retina Center· La Jolla, CARetina Consultants of Southern California· Redlands, CACalifornia Retina Consultants· Santa Maria, CALundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center· Torrance, CAColorado Retina Associates PC· Lakewood, COConneticut Eye Consultants· Danbury, CT
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