A Randomized Trial of Low-Dose Bevacizumab vs Laser for Type 1 ROP
NCT ID: NCT04634604
Last Updated: 2024-08-01
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
16 participants
INTERVENTIONAL
2022-04-27
2023-08-14
Brief Summary
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The study also will assess neurodevelopment, refractive error, visual acuity, and peripheral visual fields.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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 Occupational Safety and Health Administration (OSHA) and facility standards, will be followed.
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.
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.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
6 Months
ALL
No
Sponsors
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Pediatric Eye Disease Investigator Group
NETWORK
National Eye Institute (NEI)
NIH
Jaeb Center for Health Research
OTHER
Responsible Party
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Principal Investigators
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David K Wallace, MD, MPH
Role: STUDY_CHAIR
Indiana University
Locations
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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
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Related Links
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PEDIG Public Website
Other Identifiers
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ROP3
Identifier Type: -
Identifier Source: org_study_id
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