Bevacizumab Treatment For Type 1 ROP
ROP4
2 other identifiers
interventional
77
2 countries
26
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2022
Longer than P75 for phase_2
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 16, 2020
CompletedFirst Posted
Study publicly available on registry
November 18, 2020
CompletedStudy Start
First participant enrolled
May 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2027
ExpectedFebruary 11, 2026
February 1, 2026
3.2 years
November 16, 2020
February 9, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Treatment Success at 4 Weeks Post Injection
Treatment success, determined at 4 weeks, post injection, and meeting all the following criteria: * Improvement by the 4-day exam (3 to 5 days) * No recurrence of type 1 ROP or severe neovascularization requiring additional treatment within 4 weeks of injection.
4 weeks
Study Arms (2)
Bevacizumab- 0.063 mg
EXPERIMENTALParticipants 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.
Bevacizumab- 0.25 mg
EXPERIMENTALParticipants 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jaeb Center for Health Researchlead
- Pediatric Eye Disease Investigator Groupcollaborator
- National Eye Institute (NEI)collaborator
Study Sites (26)
Arkansas Childrens Hospital/ University of Arkansas Medical Sciences
Little Rock, Arkansas, 72202, United States
Univ of California, Irvine- Gavin Herbert Eye Institute
Irvine, California, 92697, United States
Jules Stein Eye Institute at the University of California, Los Angeles
Los Angeles, California, 90095, United States
University of California, Davis
Sacramento, California, 95817, United States
University of California San Francisco Department of Ophthalmology
San Francisco, California, 94143, United States
The Emory Eye Center
Atlanta, Georgia, 30322, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611, United States
U of Illinois at Chicago Eye and Ear Infirmary
Chicago, Illinois, 60612, United States
University of Chicago
Hyde Park, Illinois, 60637, United States
Indiana University School of Medicine
Indianapolis, Indiana, 46202, United States
Riley Hospital for Children
Indianapolis, Indiana, 46202, United States
UK Ophthalmology and Visual Sciences, The Eye Clinic
Lexington, Kentucky, 40508, United States
Greater Baltimore Medical Center
Baltimore, Maryland, 21204-5809, United States
Boston Children's Hospital
Boston, Massachusetts, 02215, United States
New York Presbyterian David H Koch Center
New York, New York, 10065, United States
Duke University Eye Center
Durham, North Carolina, 27710, United States
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229, United States
Pediatric Ophthalmology Associates, Inc.
Columbus, Ohio, 43205, United States
Casey Eye Institute
Portland, Oregon, 97239, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
UPMC Children's Eye Center of Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224, United States
Storm Eye Institute
Mt. Pleasant, South Carolina, 29464, United States
Texas Children's Hospital - Dept. Of Ophthalmology
Houston, Texas, 77030, United States
University of Utah Moran Eye Center
Salt Lake City, Utah, 84132, United States
Virginia Pediatric Eye Center
Norfolk, Virginia, 23502, United States
IWK Health Centre
Halifax, Nova Scotia, B3K 6R8, Canada
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
David K Wallace, MD, MPH
Vanderbilt University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 16, 2020
First Posted
November 18, 2020
Study Start
May 1, 2022
Primary Completion
July 1, 2025
Study Completion (Estimated)
July 1, 2027
Last Updated
February 11, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data will be made available after publication of each primary manuscript.
- Access Criteria
- Users accessing the data must enter an email address.
In accordance with the NIH data sharing policy, a de-identified database is placed in the public domain on the Pediatric Eye Disease Investigator Group (PEDIG) public website after the completion of each protocol and publication of the primary manuscript.