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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 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.

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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.

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

FieldValue
Enrollment Target 77 participants
Start Date 2022-05-01
Est. Completion 2027-07-01
Phase Phase 2

Sponsor

Jaeb Center for Health Research

119 total trials

What the Registry Record Tells You About NCT04634578

The ClinicalTrials.gov registry entry for NCT04634578 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 77 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 358-participant average among 7 other Retinopathy of Prematurity trials with a reported enrollment target (78% lower). The listed sponsor is Jaeb Center for Health Research, which has 119 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 13 distinct geographic areas - top geographies include 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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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