Bevacizumab Treatment For Posterior Zone I ROP (ROP4)
K
Kathryn Haider, MD
Primary Investigator
Overview
Type 1 retinopathy of prematurity in zone I represents the most severe type of ROP and hashe worst prognosis. It is unknown whether low-dose bevacizumab will be successful in thesevere cases. Also unknown is the timing and extent of peripheral retinal vascularizationw-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 andvessels all in zone I.
Description
Infants with type 1 ROP and no prior treatment for ROP will be randomly assigned (1:1) towith either intravitreous bevacizumab 0.063 mg or either intravitreous bevacizumab.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). Additionaludy exams will occur at adjusted age 6 and 12 months. Non-study examinations will be atdiscretion and are likely to occur more often. The primary outcome will beuccess within each dose group, defined as improvement by the day 4 exam and nourrence of type 1 ROP or severe neovascularization requiring additional treatment within 4
weeks of injection. Important secondary outcomes include safety and efficacy. refractiveutcomes, and the extent of retinal vascularization at 2 and 4 months post-injection betweenhe two dose groups.
Eligibility
You may be eligible for this study if you meet the following criteria:
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Conditions:
Retinopathy of Prematurity
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Age: - 6 Months
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Gender: All
Inclusion Criteria:
The study participant must have at least one eye meeting all of the inclusion criteria inder to be eligible to participate:1. Birth weight < 1251 grams2. Newly diagnosed (within 2 days) type 1 ROP in zone I in one or both eyesusion Criteria:Participants meeting any of the following exclusion criteria will be excluded from study.1. Previous treatment for ROP2. Stage 4 or 5 ROP in either eye3. Treatment could not be done within 2 days of diagnosis of type 1 ROP. Investigator unwilling to randomize or parent unwilling to accept randomizedgnment to either treatment5. Transfer to another hospital anticipated within the next 4 weeks where exams byudy-certified examiners are not available. If hospital discharge is anticipatedwithin the next 4 weeks, parents unable or unwilling to return to the PEDIG site forutpatient follow-up visits.6. Active ocular infection or purulent nasolacrimal duct obstruction in either eyeye will be excluded, and other eye may be eligible, if either of the following are:Visually significant ocular anomaly (e.g., cataract, coloboma)y that precludes an adequate view of the retina
Updated on
02 May 2024.
Study ID: ROP4
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