Bevacizumab Treatment For Posterior Zone I ROP (ROP4)
Retinopathy of Prematurity
About this trial
This is an interventional treatment trial for Retinopathy of Prematurity
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Sites / Locations
- Arkansas Childrens Hospital/ University of Arkansas Medical SciencesRecruiting
- Univ of California, Irvine- Gavin Herbert Eye InstituteRecruiting
- Jules Stein Eye Institute at the University of California, Los AngelesRecruiting
- University of California, Davis
- University of California San Francisco Department of OphthalmologyRecruiting
- Denver Health and Hospital Authority
- Connecticut Childrens Medical Center
- The Emory Eye CenterRecruiting
- Ann & Robert H. Lurie Children's Hospital of ChicagoRecruiting
- U of Illinois at Chicago Eye and Ear InfirmaryRecruiting
- University of ChicagoRecruiting
- Indiana University School of MedicineRecruiting
- Riley Hospital for Children
- UK Ophthalmology and Visual Sciences, The Eye ClinicRecruiting
- Greater Baltimore Medical CenterRecruiting
- Boston Children's HospitalRecruiting
- University of Missouri- Columbia Mason Eye Institute
- St. Louis University Ophthalmology
- New York Presbyterian David H Koch CenterRecruiting
- University of North Carolina
- Duke University Eye CenterRecruiting
- Cincinnati Children's HospitalRecruiting
- Pediatric Ophthalmology Associates, Inc.Recruiting
- Casey Eye InstituteRecruiting
- Children's Hospital of PhiladelphiaRecruiting
- UPMC Children's Eye Center of Children's Hospital of Pittsburgh
- Storm Eye InstituteRecruiting
- Texas Children's Hospital - Dept. Of OphthalmologyRecruiting
- The Woman's Hospital of Texas
- Texas Retina Associates
- University of Utah Moran Eye CenterRecruiting
- Virginia Pediatric Eye CenterRecruiting
- Surrey Memorial Hospital
- IWK Health Centre
- The Hospital for Sick Children
- CHU - Sainte-Justine
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Bevacizumab- 0.063 mg
Bevacizumab- 0.25 mg
Participants will receive a single intravitreal injection of 0.063 mg 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.
Participants will receive a single intravitreal injection of 0.25 mg 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.