16
Participants
Start Date
April 27, 2022
Primary Completion Date
August 14, 2023
Study Completion Date
August 14, 2023
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.
New York Presbyterian David H Koch Center, New York
UPMC Children's Eye Center of Children's Hospital of Pittsburgh, Pittsburgh
Virginia Pediatric Eye Center, Norfolk
University of North Carolina, Chapel Hill
Duke University Eye Center, Durham
Storm Eye Institute, Mt. Pleasant
The Emory Eye Center, Atlanta
UK Ophthalmology and Visual Sciences, The Eye Clinic, Lexington
Pediatric Ophthalmology Associates, Inc., Columbus
Cincinnati Children's Hospital, Cincinnati
Indiana University School of Medicine, Indianapolis
Riley Hospital for Children, Indianapolis
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
St. Louis University Ophthalmology, St Louis
University of Missouri- Columbia Mason Eye Institute, Columbia
Children's Hospital & Medical Center, Omaha
Arkansas Childrens Hospital/ University of Arkansas Medical Sciences, Little Rock
Texas Children's Hospital - Dept. Of Ophthalmology, Houston
The Woman's Hospital of Texas, Houston
University of Colorado Health Sciences Center, Aurora
Denver Health and Hospital Authority, Denver
University of Utah Moran Eye Center, Salt Lake City
Arizonia Pediatric Eye Specialists, Phoenix
Univ of California, Irvine- Gavin Herbert Eye Institute, Irvine
University of California San Francisco Department of Ophthalmology, San Francisco
University of California, Davis, Sacramento
Casey Eye Institute, Portland
Connecticut Childrens Medical Center, Farmington
Greater Baltimore Medical Center, Baltimore
Boston Children's Hospital, Boston
IWK Health Centre, Halifax
The Hospital for Sick Children, Toronto
CHU - Sainte-Justine, Montreal
Lead Sponsor
Pediatric Eye Disease Investigator Group
NETWORK
National Eye Institute (NEI)
NIH
Jaeb Center for Health Research
OTHER