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NCT04049266 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Efficacy and Safety of KSI-301, an Anti-VEGF Antibody Biopolymer Conjugate, Versus Aflibercept in Patients With Neovascular (Wet) Age-Related Macular Degeneration.
A Phase 2 study, sponsored by Kodiak Sciences.
- Terminated
- Registry status
- Phase 2
- Development phase
- 559
- Enrollment target
NCT04049266: Clinical Trial Phase 2 study, sponsored by Kodiak Sciences.
NCT04049266 is a Phase 2 study that was terminated before completion, run by Kodiak Sciences. The registered enrollment target is 559 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (320% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04049266, a Phase 2 study, was terminated before completion, sponsored by Kodiak Sciences.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 559 participants
- Enrollment target
Study Summary
This study will evaluate the efficacy, safety, durability, and pharmacokinetics of KSI-301 administered at 12, 16 and 20 weeks intervals as specified in the protocol, compared with aflibercept once every 8 weeks (Q8W), in participants with treatment-naïve neovascular (wet) age-related macular degeneration (nAMD).
Primary Outcome
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 | 559 participants |
| Start Date | 2019-10-08 |
| Est. Completion | 2022-04-26 |
| Phase | Phase 2 |
Why NCT04049266 stopped before completion
NCT04049266 is an interventional study that assigns participants to a tested intervention. The registered 559 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (320% higher).
The record links to 0 conditions, and to 3 interventions - of which Sham Procedure is the first listed.
NCT04049266 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04049266 about?
NCT04049266 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of KSI-301, an Anti-VEGF Antibody Biopolymer Conjugate, Versus Aflibercept in Patients With Neovascular (Wet) Age-Related Macular Degeneration.". This study will evaluate the efficacy, safety, durability, and pharmacokinetics of KSI-301 administered at 12, 16 and 20 weeks intervals as specified in the protocol, compared with aflibercept once every 8 weeks (Q8W), in participants with treatment-naïve neovascular (wet) age-related macular degene...
What is the current status of trial NCT04049266?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 559 participants. The study started on 2019-10-08. Estimated completion is 2022-04-26.
What interventions are being tested in trial NCT04049266?
The interventions under investigation include: Sham Procedure (OTHER), Aflibercept (DRUG), KSI-301 (DRUG).
Who is sponsoring clinical trial NCT04049266?
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 NCT04049266's enrollment target sits among peer trials
559 60th of 2000 higher than 1,941 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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