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NCT04611152 · ClinicalTrials.gov registry record · Phase 3
A Trial to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Participants With Diabetic Macular Edema (DME)
A Phase 3 study, sponsored by Kodiak Sciences.
- Terminated
- Registry status
- Phase 3
- Development phase
- 460
- Enrollment target
NCT04611152: Clinical Trial Phase 3 study, sponsored by Kodiak Sciences.
NCT04611152 is a Phase 3 study that was terminated before completion, run by Kodiak Sciences. The registered enrollment target is 460 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04611152, a Phase 3 study, was terminated before completion, sponsored by Kodiak Sciences.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 460 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 treatment-naïve DME.
Primary Outcome
Mean change in best-corrected visual acuity (BCVA) from baseline to the average of Weeks 60 and 64 (using Early Treatment Diabetic Retinopathy Study (ETDRS) Letters). Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity.
Interventions
- OTHER Sham Procedure
- DRUG Aflibercept
- DRUG KSI-301
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 460 participants |
| Start Date | 2020-09-30 |
| Est. Completion | 2023-08-31 |
| Phase | Phase 3 |
Why NCT04611152 stopped before completion
NCT04611152 is an interventional study that assigns participants to a tested intervention. The registered 460 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 (40% lower).
The record links to 0 conditions, and to 3 interventions - of which Sham Procedure is the first listed.
NCT04611152 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04611152 about?
NCT04611152 is a clinical study titled "A Trial to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Participants With Diabetic Macular Edema (DME)". This Phase 3 study will evaluate the efficacy, durability, and safety of KSI-301 compared to aflibercept in participants with treatment-naïve DME.
What is the current status of trial NCT04611152?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 460 participants. The study started on 2020-09-30. Estimated completion is 2023-08-31.
What interventions are being tested in trial NCT04611152?
The interventions under investigation include: Sham Procedure (OTHER), Aflibercept (DRUG), KSI-301 (DRUG).
Who is sponsoring clinical trial NCT04611152?
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 NCT04611152's enrollment target sits among peer trials
460 823rd of 2000 higher than 1,174 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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