A Randomized Trial of Low-Dose Bevacizumab vs Laser for Type 1 ROP
Part of paid clinical trials in Phoenix, Arizona.
- Sponsor
- Jaeb Center for Health Research
- Study ID
- NCT04634604
- Phase
- PHASE3
- Status
- Terminated
Conditions
- Retinopathy of Prematurity
Eligibility Criteria
- Sex
- ALL
- Age
- N/A - 6 Months
- Healthy Volunteers
- Not accepted
Interventions
- Bevacizumab — DRUGFor 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 — PROCEDUREFor 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.
Study Details
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.
Key Dates
- First listed
- Nov 18, 2020
- Start date
- Apr 27, 2022
- Status verified
- May 2026
- Primary completion
- Aug 14, 2023
- Completion
- Aug 14, 2023
Study Design
- Enrollment
- 16 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: LaserFor 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.
- Experimental: BevacizumabFor 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 Measure
Treatment Success Rate At 6 Months Adjusted Age [ Time Frame: 6 Months Adjusted Age ]
Locations (32)
Find similar trials in Phoenix, AZ
By research site
Arizonia Pediatric Eye Specialists· Phoenix, AZArkansas Childrens Hospital/ University of Arkansas Medical Sciences· Little Rock, ARUniv of California, Irvine- Gavin Herbert Eye Institute· Irvine, CAUniversity of California, Davis· Sacramento, CAUniversity of California San Francisco Department of Ophthalmology· San Francisco, CAUniversity of Colorado Health Sciences Center· Aurora, CO
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