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ACTIVE NOT RECRUITING
NCT04634578
PHASE2

Bevacizumab Treatment For Type 1 ROP

Sponsor: Jaeb Center for Health Research

View on ClinicalTrials.gov

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.

Official title: Bevacizumab Treatment For Type 1 Retinopathy of Prematurity

Key Details

Gender

All

Age Range

Any - 6 Months

Study Type

INTERVENTIONAL

Enrollment

77

Start Date

2022-05-01

Completion Date

2027-07-01

Last Updated

2026-02-11

Healthy Volunteers

No

Interventions

DRUG

Bevacizumab

All participants will receive a single intravitreal injection of bevacizumab in one or both eyes following enrollment into the study. The injection/s should be given as soon as possible but no later than 2 days after the diagnosis of type 1 ROP meeting all of the inclusion criteria and none of the exclusion criteria. Eyes meeting eligibility criteria will receive a single dose of 0.063 mg or 0.25mg bevacizumab provided by the pharmacy at the investigator's institution.

Locations (26)

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

IWK Health Centre

Halifax, Nova Scotia, Canada