Phase 1 Trial of Bevacizumab Treatment for Severe Retinopathy of Prematurity

Completed · Phase 1

Conditions studied: Retinopathy of Prematurity

In brief

The purpose of this study is to find a dose of intravitreal bevacizumab that is lower than currently used for severe retinopathy of prematurity (ROP), is effective in this study, and can be tested in future larger studies.

Key facts

Study ID

NCT02390531

Run by

Jaeb Center for Health Research

People needed

120

Starts

2015-04-28

Expected to finish

2021-05-11

Last updated by the study team

2022-11-03

Who can join

Age: any, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Type 1 ROP; defined as:
• Zone I, any stage ROP with plus disease, or
• Zone I, stage 3 ROP without plus disease, or
• Zone II, stage 2 or 3 ROP with plus disease
• No previous treatment for ROP in the study eye; no previous bevacizumab treatment in the non-study eye

You may not qualify if…

• The following exclusions apply to the study eye:
• Nasolacrimal duct obstruction
• Major ocular anomalies (e.g., cataract, coloboma)
• Any opacity that precludes an adequate view of the retina
• If purulent ocular discharge is present in either eye, then the infant is ineligible.

Where it is running

• The Emory Eye Center — Atlanta, Georgia, United States
• Riley Hospital for Children — Indianapolis, Indiana, United States
• Wilmer Institute — Baltimore, Maryland, United States
• Boston Children's Hospital — Boston, Massachusetts, United States
• Duke University Eye Center — Durham, North Carolina, United States
• Cincinnati Children's Hospital — Cincinnati, Ohio, United States
• Pediatric Ophthalmology Associates, Inc. — Columbus, Ohio, United States
• Dean A. McGee Eye Institute, University of Oklahoma — Oklahoma City, Oklahoma, United States
• Texas Children's Hospital - Dept. Of Ophthalmology — Houston, Texas, United States
• University of Utah Moran Eye Center — Salt Lake City, Utah, United States
• Virginia Pediatric Eye Center — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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