A Randomized Trial of Low-Dose Bevacizumab vs Laser for Type 1 ROP
- Registration Number
- NCT04634604
- Lead Sponsor
- Jaeb Center for Health Research
- 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.
- Detailed Description
Infants with type 1 ROP and no prior treatment for ROP will be randomly assigned (1:1) to treatment with either intravitreous bevacizumab 0.063 mg or peripheral retinal laser ablation. Study exams will be at weeks 1, 2, and 4 weeks, and at 2 and 4-months post-treatment (and re-treatment when indicated). Additional study exams will occur at adjusted age 6 months, 1 year, and then annually for 5 more years. Non-study examinations will be at clinician discretion and are likely to occur more often. The primary outcome will be treatment success, defined as no worsening of ROP 5-13 days after treatment (or re-treatment if indicated), no plus disease or severe neovascularization 2 weeks to 6 months after treatment (or re-treatment if indicated), and no unfavorable structural outcome (or prior scleral buckle or vitrectomy) at 6 months adjusted age. Important secondary outcomes include the number of re-treatments, extent of retinal vascularization, refractive error, neurodevelopment assessed by the Bayley-4 test, IQ and neuropsychiatric testing, visual acuity, visual fields, and systemic morbidities.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 16
-
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Laser 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. Bevacizumab 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.
- Primary Outcome Measures
Name Time Method Treatment Success Rate At 6 Months Adjusted Age 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).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (35)
The Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada
Univ of California, Irvine- Gavin Herbert Eye Institute
🇺🇸Irvine, California, United States
Connecticut Childrens Medical Center
🇺🇸Farmington, Connecticut, United States
U of Illinois at Chicago Eye and Ear Infirmary
🇺🇸Chicago, Illinois, United States
University of Chicago
🇺🇸Hyde Park, Illinois, United States
Greater Baltimore Medical Center
🇺🇸Baltimore, Maryland, United States
Riley Hospital for Children
🇺🇸Indianapolis, Indiana, United States
New York Presbyterian David H Koch Center
🇺🇸New York, New York, United States
University of Missouri- Columbia Mason Eye Institute
🇺🇸Columbia, Missouri, United States
St. Louis University Ophthalmology
🇺🇸Saint Louis, Missouri, United States
Duke University Eye Center
🇺🇸Durham, North Carolina, United States
UPMC Children's Eye Center of Children's Hospital of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
The Woman's Hospital of Texas
🇺🇸Houston, Texas, United States
Virginia Pediatric Eye Center
🇺🇸Norfolk, Virginia, United States
IWK Health Centre
🇨🇦Halifax, Nova Scotia, Canada
CHU - Sainte-Justine
🇨🇦Montreal, Quebec, Canada
The Emory Eye Center
🇺🇸Atlanta, Georgia, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
🇺🇸Chicago, Illinois, United States
Indiana University School of Medicine
🇺🇸Indianapolis, Indiana, United States
UK Ophthalmology and Visual Sciences, The Eye Clinic
🇺🇸Lexington, Kentucky, United States
Pediatric Ophthalmology Associates, Inc.
🇺🇸Columbus, Ohio, United States
Texas Children's Hospital - Dept. Of Ophthalmology
🇺🇸Houston, Texas, United States
Cincinnati Children's Hospital
🇺🇸Cincinnati, Ohio, United States
University of Utah Moran Eye Center
🇺🇸Salt Lake City, Utah, United States
University of California San Francisco Department of Ophthalmology
🇺🇸San Francisco, California, United States
Boston Children's Hospital
🇺🇸Boston, Massachusetts, United States
Storm Eye Institute
🇺🇸Mount Pleasant, South Carolina, United States
Arkansas Childrens Hospital/ University of Arkansas Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Arizonia Pediatric Eye Specialists
🇺🇸Phoenix, Arizona, United States
Denver Health and Hospital Authority
🇺🇸Denver, Colorado, United States
Casey Eye Institute
🇺🇸Portland, Oregon, United States
University of California, Davis
🇺🇸Sacramento, California, United States
University of Colorado Health Sciences Center
🇺🇸Aurora, Colorado, United States
Children's Hospital & Medical Center
🇺🇸Omaha, Nebraska, United States
University of North Carolina
🇺🇸Chapel Hill, North Carolina, United States