Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
77 participants
INTERVENTIONAL
2022-05-01
2027-07-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Bevacizumab- 0.063 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.
Bevacizumab
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.
Bevacizumab- 0.25 mg
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.
Bevacizumab
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.
Interventions
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Bevacizumab
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Newly diagnosed (within 2 days) type 1 ROP in zone I in one or both eyes
Exclusion Criteria
2. Stage 4 or 5 ROP in either eye
3. Treatment could not be done within 2 days of diagnosis of type 1 ROP
4. Investigator unwilling to randomize or parent unwilling to accept randomized assignment to either treatment
5. 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.
6. 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
Vanderbilt University
Locations
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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
Jules Stein Eye Institute at the University of California, Los Angeles
Los Angeles, California, United States
University of California, Davis
Sacramento, California, United States
University of California San Francisco Department of Ophthalmology
San Francisco, California, 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
New York Presbyterian David H Koch Center
New York, New York, 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
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 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
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
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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ROP4
Identifier Type: -
Identifier Source: org_study_id
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