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A Randomized Trial of Low-Dose Bevacizumab vs Laser for Type 1 ROP
Sponsor: Jaeb Center for Health Research
Summary
This randomized clinical trial will compare retinal outcomes with low-dose intravitreous bevacizumab (0.063 mg) versus laser photocoagulation as treatment for infants with type 1 retinopathy of prematurity (ROP). The study also will assess neurodevelopment, refractive error, visual acuity, and peripheral visual fields.
Official title: A Randomized Trial of Low-Dose Bevacizumab Versus Laser for Type 1 Retinopathy of Prematurity
Key Details
Gender
All
Age Range
Any - 6 Months
Study Type
INTERVENTIONAL
Enrollment
16
Start Date
2022-04-27
Completion Date
2023-08-14
Last Updated
2026-09-14
Healthy Volunteers
No
Conditions
Interventions
Bevacizumab
For infants randomized to bevacizumab, the Intravitreous bevacizumab 0.063 mg injection will be given no later than 2 days after the diagnosis of type 1 ROP. The ophthalmologist may choose to give the intravitreous injection in the operating room or at the bedside, with or without anesthesia, after consultation with the attending neonatologist. A binocular indirect ophthalmoscope with an appropriate condensing lens should be available, and the pupils should be dilated.
Laser
For infants randomized to laser treatment, it will be given in conjunction with a binocular indirect ophthalmoscope and an appropriate condensing lens, by a study-certified ophthalmologist experienced in the use of this equipment. The treating investigator will be certified as having sufficient experience with laser for ROP, and adequacy of laser treatment will be confirmed by expert review of photographs. Special laser precautions, as mandated by OSHA and facility standards, will be followed.
Locations (35)
Arizonia Pediatric Eye Specialists
Phoenix, Arizona, United States
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
University of California, Davis
Sacramento, California, United States
University of California San Francisco Department of Ophthalmology
San Francisco, California, United States
University of Colorado Health Sciences Center
Aurora, Colorado, United States
Denver Health and Hospital Authority
Denver, Colorado, United States
Connecticut Childrens Medical Center
Farmington, Connecticut, 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
University of Missouri- Columbia Mason Eye Institute
Columbia, Missouri, United States
St. Louis University Ophthalmology
St Louis, Missouri, United States
Children's Hospital & Medical Center
Omaha, Nebraska, United States
New York Presbyterian David H Koch Center
New York, New York, United States
University of North Carolina
Chapel Hill, North Carolina, 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
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
The Woman's Hospital of Texas
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
The Hospital for Sick Children
Toronto, Ontario, Canada
CHU - Sainte-Justine
Montreal, Quebec, Canada