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NCT04634578 · ClinicalTrials.gov registry record · Phase 2
Bevacizumab Treatment For Type 1 ROP
A Phase 2 study of Retinopathy of Prematurity, sponsored by Jaeb Center for Health Research.
- Active
- Registry status
- Phase 2
- Development phase
- 77
- Enrollment target
- 20
- Study locations
NCT04634578: Active Phase 2 study of Retinopathy of Prematurity, sponsored by Jaeb Center for Health Research.
NCT04634578 is a Phase 2 study of Retinopathy of Prematurity that is active but no longer recruiting, run by Jaeb Center for Health Research. The registered enrollment target is 77 participants, below the 358-participant average among 7 other Retinopathy of Prematurity trials with a reported enrollment target (78% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04634578, a Phase 2 study of Retinopathy of Prematurity, is active but no longer recruiting, sponsored by Jaeb Center for Health Research.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 77 participants
- Enrollment target
- 20
- Study locations
Study Summary
Type 1 retinopathy of prematurity in zone I represents the most severe type of ROP and has the worst prognosis. It is unknown whether low-dose bevacizumab will be successful in these severe cases. Also unknown is the timing and extent of peripheral retinal vascularization after low-dose bevacizumab compared with the standard dose. The current study will evaluate whether doses of 0.063 mg and 0.25mg are effective as treatment for type 1 ROP, with ROP and retinal vessels all in zone I.
Primary Outcome
Treatment success, determined at 4 weeks, post injection, and meeting all the following criteria: * Improvement by the 4-day exam (3 to 5 days) * No recurrence of type 1 ROP or severe neovascularization requiring additional treatment within 4 weeks of injection.
Conditions Studied
Interventions
- DRUG Bevacizumab
Study Locations (20)
California
- Univ of California, Irvine- Gavin Herbert Eye Institute - Irvine
- Jules Stein Eye Institute at the University of California, Los Angeles - Los Angeles
- University of California, Davis - Sacramento
- University of California San Francisco Department of Ophthalmology - San Francisco
Illinois
- Ann & Robert H. Lurie Children's Hospital of Chicago - Chicago
- U of Illinois at Chicago Eye and Ear Infirmary - Chicago
- University of Chicago - Hyde Park
Indiana
- Indiana University School of Medicine - Indianapolis
- Riley Hospital for Children - Indianapolis
Ohio
- Cincinnati Children's Hospital - Cincinnati
- Pediatric Ophthalmology Associates, Inc. - Columbus
Arkansas
- Arkansas Childrens Hospital/ University of Arkansas Medical Sciences - Little Rock
Georgia
- The Emory Eye Center - Atlanta
Kentucky
- UK Ophthalmology and Visual Sciences, The Eye Clinic - Lexington
Maryland
- Greater Baltimore Medical Center - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 77 participants |
| Start Date | 2022-05-01 |
| Est. Completion | 2027-07-01 |
| Phase | Phase 2 |
What the registry record for NCT04634578 still lists
NCT04634578 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 77 participants, a relatively small participant target, below the 358-participant average among 7 other Retinopathy of Prematurity trials with a reported enrollment target (78% lower).
The record links to 1 condition, with Retinopathy of Prematurity appearing as the primary indexed condition, and to 1 intervention - of which Bevacizumab is the first listed.
NCT04634578 names 20 study sites across 13 states, led by California, Illinois, Indiana.
Frequently Asked Questions
What is clinical trial NCT04634578 about?
NCT04634578 is a clinical study titled "Bevacizumab Treatment For Type 1 ROP". Type 1 retinopathy of prematurity in zone I represents the most severe type of ROP and has the worst prognosis. It is unknown whether low-dose bevacizumab will be successful in these severe cases. Also unknown is the timing and extent of peripheral retinal vascularization after low-dose bevacizumab ...
What is the current status of trial NCT04634578?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 77 participants. The study started on 2022-05-01. Estimated completion is 2027-07-01.
What conditions does trial NCT04634578 study?
This clinical trial studies the following conditions: Retinopathy of Prematurity.
What interventions are being tested in trial NCT04634578?
The interventions under investigation include: Bevacizumab (DRUG).
Who is sponsoring clinical trial NCT04634578?
This trial is sponsored by Jaeb Center for Health Research, which has 119 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04634578 being conducted?
This trial has 20 study locations across Arkansas, California, Georgia, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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