Bevacizumab Treatment For Type 1 ROP

Running, not enrolling · Phase 2

Conditions studied: Retinopathy of Prematurity

In brief

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.

Key facts

Study ID

NCT04634578

Run by

Jaeb Center for Health Research

People needed

77

Starts

2022-05-01

Expected to finish

2027-07-01

Last updated by the study team

2026-02-11

Who can join

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

You may qualify if…

• The study participant must have at least one eye meeting all of the inclusion criteria in order to be eligible to participate:
• Birth weight < 1251 grams
• Newly diagnosed (within 2 days) type 1 ROP in zone I in one or both eyes

You may not qualify if…

• Participants meeting any of the following exclusion criteria will be excluded from study participation.
• Previous treatment for ROP
• Stage 4 or 5 ROP in either eye
• Treatment could not be done within 2 days of diagnosis of type 1 ROP
• Investigator unwilling to randomize or parent unwilling to accept randomized assignment to either treatment
• Transfer to another hospital anticipated within the next 4 weeks where exams by study-certified examiners are not available. If hospital discharge is anticipated within the next 4 weeks, parents unable or unwilling to return to the PEDIG site for outpatient follow-up visits.
• Active ocular infection or purulent nasolacrimal duct obstruction in either eye
• One eye will be excluded, and other eye may be eligible, if either of the following are present:
• Visually significant ocular anomaly (e.g., cataract, coloboma)
• Opacity that precludes an adequate view of the retina

Where it is running

• Arkansas Childrens Hospital/ University of Arkansas Medical Sciences — Little Rock, Arkansas, United States
• Univ of California, Irvine- Gavin Herbert Eye Institute — Irvine, California, United States
• Jules Stein Eye Institute at the University of California, Los Angeles — Los Angeles, California, United States
• University of California, Davis — Sacramento, California, United States
• University of California San Francisco Department of Ophthalmology — San Francisco, California, United States
• The Emory Eye Center — Atlanta, Georgia, United States
• Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
• U of Illinois at Chicago Eye and Ear Infirmary — Chicago, Illinois, United States
• University of Chicago — Hyde Park, Illinois, United States
• Indiana University School of Medicine — Indianapolis, Indiana, United States
• Riley Hospital for Children — Indianapolis, Indiana, United States
• UK Ophthalmology and Visual Sciences, The Eye Clinic — Lexington, Kentucky, United States
• Greater Baltimore Medical Center — Baltimore, Maryland, United States
• Boston Children's Hospital — Boston, Massachusetts, United States
• New York Presbyterian David H Koch Center — New York, New York, 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
• Casey Eye Institute — Portland, Oregon, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• UPMC Children's Eye Center of Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Storm Eye Institute — Mt. Pleasant, South Carolina, 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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