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NCT04634604 · ClinicalTrials.gov registry record · Phase 3
A Randomized Trial of Low-Dose Bevacizumab vs Laser for Type 1 ROP
A Phase 3 study, sponsored by Jaeb Center for Health Research.
- Terminated
- Registry status
- Phase 3
- Development phase
- 16
- Enrollment target
NCT04634604: Clinical Trial Phase 3 study, sponsored by Jaeb Center for Health Research.
NCT04634604 is a Phase 3 study that was terminated before completion, run by Jaeb Center for Health Research. The registered enrollment target is 16 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04634604, a Phase 3 study, was terminated before completion, sponsored by Jaeb Center for Health Research.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 16 participants
- Enrollment target
Study Summary
This randomized clinical trial will compare retinal outcomes with low-dose intravitreous bevacizumab (0.063 mg) versus laser photocoagulation as treatment for infants with type 1 retinopathy of prematurity (ROP). The study also will assess neurodevelopment, refractive error, visual acuity, and peripheral visual fields.
Primary Outcome
The primary objective for the randomized trial is to determine if infants with type 1 ROP treated with intravitreal bevacizumab (subsequently referred to as BV) have a treatment success rate determined at 6 months adjusted age that is non-inferior compared with infants treated with laser photocoagulation (subsequently referred to as LASER).
Interventions
- DRUG Bevacizumab
- PROCEDURE Laser
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2022-04-27 |
| Est. Completion | 2023-08-14 |
| Phase | Phase 3 |
Why NCT04634604 stopped before completion
NCT04634604 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Bevacizumab is the first listed.
NCT04634604 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04634604 about?
NCT04634604 is a clinical study titled "A Randomized Trial of Low-Dose Bevacizumab vs Laser for Type 1 ROP". This randomized clinical trial will compare retinal outcomes with low-dose intravitreous bevacizumab (0.063 mg) versus laser photocoagulation as treatment for infants with type 1 retinopathy of prematurity (ROP). The study also will assess neurodevelopment, refractive error, visual acuity, and peri...
What is the current status of trial NCT04634604?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 16 participants. The study started on 2022-04-27. Estimated completion is 2023-08-14.
What interventions are being tested in trial NCT04634604?
The interventions under investigation include: Bevacizumab (DRUG), Laser (PROCEDURE).
Who is sponsoring clinical trial NCT04634604?
This trial is sponsored by Jaeb Center for Health Research, which has 119 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04634604's enrollment target sits among peer trials
16 1974th of 2000 higher than 24 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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