Study Stopped
Lack of feasibility to recruit.
A Randomized Trial of Low-Dose Bevacizumab vs Laser for Type 1 ROP
ROP3
2 other identifiers
interventional
16
2 countries
35
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Apr 2022
Shorter than P25 for phase_3
35 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
April 27, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 14, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 14, 2023
CompletedResults Posted
Study results publicly available
August 1, 2024
CompletedAugust 1, 2024
July 1, 2024
1.3 years
November 16, 2020
June 24, 2024
July 29, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Treatment Success Rate At 6 Months Adjusted Age
The primary objective for the randomized trial is to determine if infants with type 1 ROP treated with intravitreal bevacizumab (subsequently referred to as BV) have a treatment success rate determined at 6 months adjusted age that is non-inferior compared with infants treated with laser photocoagulation (subsequently referred to as LASER).
6 Months Adjusted Age
Study Arms (2)
Laser
ACTIVE COMPARATORFor 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 Occupational Safety and Health Administration (OSHA) and facility standards, will be followed.
Bevacizumab
EXPERIMENTALFor 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Birth weight \< 1251 grams
- Newly diagnosed (within 2 days) type 1 ROP in one or both eyes; meeting the following criteria:
- Zone I, any stage ROP with plus disease, with retinal vessels or ROP in Zone II in any quadrant, or
- Zone I, stage 3 ROP without plus disease, with retinal vessels or ROP in zone II in any quadrant or
- Zone II, stage 2 or 3 ROP with plus disease
You may not qualify if:
- Previous treatment for ROP
- Stage 4 or 5 ROP in either eye
- All ROP in zone I in either eye (no retinal vessels or ROP extend into zone II in any quadrant)
- Either treatment could not be done within 2 days of diagnosis of type 1 ROP
- Investigator unwilling to randomize or parent unwilling to accept random assignment to either treatment
- Transfer to another hospital not covered by study-certified examiners anticipated within the next 4 weeks
- 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 (35)
Arizonia Pediatric Eye Specialists
Phoenix, Arizona, 85006, United States
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
University of California, Davis
Sacramento, California, 95817, United States
University of California San Francisco Department of Ophthalmology
San Francisco, California, 94143, United States
University of Colorado Health Sciences Center
Aurora, Colorado, 80045, United States
Denver Health and Hospital Authority
Denver, Colorado, 80204, United States
Connecticut Childrens Medical Center
Farmington, Connecticut, 06032, 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
University of Missouri- Columbia Mason Eye Institute
Columbia, Missouri, 65201, United States
St. Louis University Ophthalmology
St Louis, Missouri, 63104, United States
Children's Hospital & Medical Center
Omaha, Nebraska, 68114, United States
New York Presbyterian David H Koch Center
New York, New York, 10065, United States
University of North Carolina
Chapel Hill, North Carolina, 27599, 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
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
The Woman's Hospital of Texas
Houston, Texas, 77054, 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
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8, Canada
CHU - Sainte-Justine
Montreal, Quebec, H3T 1C5, Canada
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Early termination leading to small numbers of subjects which precluded statistical analysis. Active participants were released from study at time of study termination.
Results Point of Contact
- Title
- Ray Kraker
- Organization
- Jaeb Center for Health Research
Study Officials
- STUDY CHAIR
David K Wallace, MD, MPH
Indiana University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- 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
April 27, 2022
Primary Completion
August 14, 2023
Study Completion
August 14, 2023
Last Updated
August 1, 2024
Results First Posted
August 1, 2024
Record last verified: 2024-07
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.
Yes 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.