Type 1 retinopathy of prematurity in zone I represents the most severe type of ROP and has the worst prognosis. It is unknown whether low-dose bevacizumab will be successful in these severe cases. Also unknown is the timing and extent of peripheral retinal vascularization after low-dose bevacizumab compared with the standard dose. The current study will evaluate whether doses of 0.063 mg and 0.25mg are effective as treatment for type 1 ROP, with ROP and retinal vessels all in zone I.
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 either intravitreous bevacizumab 0.25 mg. Study exams will be at 1 day, 4 days (if no improvement on day 1), 1, 2, 3, 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 and 12 months. Non-study examinations will be at clinician discretion and are likely to occur more often. The primary outcome will be treatment success within each dose group, defined as improvement by the day 4 exam and no recurrence of type 1 ROP or severe neovascularization requiring additional treatment within 4 weeks of injection. Important secondary outcomes include safety and efficacy. refractive outcomes, and the extent of retinal vascularization at 2 and 4 months post-injection between the two dose groups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
77
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.
Treatment Success at 4 Weeks Post Injection
Treatment success, determined at 4 weeks, post injection, and meeting all the following criteria: * Improvement by the 4-day exam (3 to 5 days) * No recurrence of type 1 ROP or severe neovascularization requiring additional treatment within 4 weeks of injection.
Time frame: 4 weeks
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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
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