Journal article
A Dosing Study of Bevacizumab for Retinopathy of Prematurity: Late Recurrences and Additional Treatments
Ophthalmology (Rochester, Minn.), Vol.125(12), pp.1961-1966
12/2018
DOI: 10.1016/j.ophtha.2018.05.001
PMCID: PMC6402322
PMID: 29887334
Abstract
Intravitreal bevacizumab is increasingly used to treat severe retinopathy of prematurity (ROP), but it enters the bloodstream, and there is concern that it may alter development of other organs. Previously we reported short-term outcomes of 61 infants enrolled in a dose de-escalation study, and we report the late recurrences and additional treatments.
Masked, multicenter, dose de-escalation study.
A total of 61 premature infants with type 1 ROP.
If type 1 ROP was bilateral at enrollment, then the study eye was randomly selected. In the study eye, bevacizumab intravitreal injections were given at de-escalating doses of 0.25 mg, 0.125 mg, 0.063 mg, or 0.031 mg; if needed, fellow eyes received 1 dose level higher: 0.625 mg, 0.25 mg, 0.125 mg, or 0.063 mg, respectively. After 4 weeks, additional treatment was at the discretion of the investigator.
Early and late ROP recurrences, additional treatments, and structural outcomes after 6 months.
Of 61 study eyes, 25 (41%; 95% confidence interval [CI], 29%-54%) received additional treatment: 3 (5%; 95% CI, 1%-14%) for early failure (within 4 weeks), 11 (18%; 95% CI, 9%-30%) for late recurrence of ROP (after 4 weeks), and 11 (18%; 95% CI, 9%-30%) for persistent avascular retina. Re-treatment for early failure or late recurrence occurred in 2 of 11 eyes (18%; 95% CI, 2%-52%) treated with 0.25 mg, 4 of 16 eyes (25%; 95% CI, 7%-52%) treated with 0.125 mg, 8 of 24 eyes (33%; 95% CI, 16%-55%) treated with 0.063 mg, and 0 (0%; 95% CI, 0%-31%) of 10 eyes treated with 0.031 mg. By 6 months corrected age, 56 of 61 study eyes had regression of ROP with normal posterior poles, 1 study eye had developed a Stage 5 retinal detachment, and 4 infants had died of preexisting medical conditions.
Retinal structural outcomes are very good after low-dose bevacizumab treatment for ROP, although many eyes received additional treatment.
Details
- Title: Subtitle
- A Dosing Study of Bevacizumab for Retinopathy of Prematurity: Late Recurrences and Additional Treatments
- Creators
- David K Wallace - University of IndianapolisTrevano W Dean - Jaeb Center for Health ResearchMary Elizabeth Hartnett - Moran Eye CenterLingkun Kong - Texas Tech University Health Sciences CenterLois E Smith - Boston Children's HospitalG Baker Hubbard - Emory Eye CenterMary Lou McGregor - Ophthalmology AssociatesCatherine O Jordan - Ophthalmology AssociatesIason S Mantagos - Boston Children's HospitalEdward F Bell - University of IowaRaymond T Kraker - Jaeb Center for Health ResearchPediatric Eye Disease Investigator Group
- Resource Type
- Journal article
- Publication Details
- Ophthalmology (Rochester, Minn.), Vol.125(12), pp.1961-1966
- DOI
- 10.1016/j.ophtha.2018.05.001
- PMID
- 29887334
- PMCID
- PMC6402322
- ISSN
- 0161-6420
- eISSN
- 1549-4713
- Grant note
- R24 EY024864 / NEI NIH HHS U10 EY011751 / NEI NIH HHS UG1 EY011751 / NEI NIH HHS U54 HD090255 / NICHD NIH HHS R01 EY017017 / NEI NIH HHS U10 EY023198 / NEI NIH HHS U10 EY018810 / NEI NIH HHS
- Language
- English
- Date published
- 12/2018
- Academic Unit
- Stead Family Department of Pediatrics; Neonatology
- Record Identifier
- 9984354147502771
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