Trials / Completed
CompletedNCT04964089
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)
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)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 557 (actual)
- Sponsor
- Kodiak Sciences Inc · Industry
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Not accepted
Summary
This Phase 3 study will evaluate the efficacy and safety of KSI-301 compared to aflibercept, in participants with neovascular (wet) age-related macular degeneration (wAMD)
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 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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | KSI-301 | Intravitreal Injection |
| DRUG | Aflibercept | Intravitreal Injection |
| 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. |
Timeline
- Start date
- 2021-06-23
- Primary completion
- 2023-03-28
- Completion
- 2023-04-06
- First posted
- 2021-07-15
- Last updated
- 2024-07-03
- Results posted
- 2024-05-02
Locations
66 sites across 2 countries: United States, Puerto Rico
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04964089. Inclusion in this directory is not an endorsement.