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NCT04592419 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Patients With Macular Edema Due to Retinal Vein Occlusion (RVO)
A Phase 3 study, sponsored by Kodiak Sciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 568
- Enrollment target
NCT04592419: Completed Phase 3 study, sponsored by Kodiak Sciences.
NCT04592419 is a Phase 3 study that has completed, run by Kodiak Sciences. The registered enrollment target is 568 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (26% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04592419, a Phase 3 study, has completed, sponsored by Kodiak Sciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 568 participants
- Enrollment target
Study Summary
This Phase 3 study will evaluate the efficacy, durability, and safety of KSI-301 compared to aflibercept, in participants with macular edema due to treatment-naïve branch (BRVO) or central retinal vein occlusion (CRVO).
Primary Outcome
BCVA as a continuous variable measured at each study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA approach.
Interventions
- OTHER Sham Procedure
- DRUG Aflibercept
- DRUG KSI-301
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 568 participants |
| Start Date | 2020-09-25 |
| Est. Completion | 2023-01-19 |
| Phase | Phase 3 |
What the finished NCT04592419 record still lists
NCT04592419 is an interventional study that assigns participants to a tested intervention. The registered 568 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (26% lower).
The record links to 0 conditions, and to 3 interventions - of which Sham Procedure is the first listed.
NCT04592419 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04592419 about?
NCT04592419 is a clinical study titled "A Study to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Patients With Macular Edema Due to Retinal Vein Occlusion (RVO)". This Phase 3 study will evaluate the efficacy, durability, and safety of KSI-301 compared to aflibercept, in participants with macular edema due to treatment-naïve branch (BRVO) or central retinal vein occlusion (CRVO).
What is the current status of trial NCT04592419?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 568 participants. The study started on 2020-09-25. Estimated completion is 2023-01-19.
What interventions are being tested in trial NCT04592419?
The interventions under investigation include: Sham Procedure (OTHER), Aflibercept (DRUG), KSI-301 (DRUG).
Who is sponsoring clinical trial NCT04592419?
This trial is sponsored by Kodiak Sciences, which has 11 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04592419's enrollment target sits among peer trials
568 666th of 2000 higher than 1,334 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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