Evidence map›Paper›PMID 29887334›Full record

Trial reportOphthalmology2018

A Dosing Study of Bevacizumab for Retinopathy of Prematurity: Late Recurrences and Additional Treatments.

David K Wallace, Trevano W Dean, Mary Elizabeth Hartnett, Lingkun Kong, Lois E Smith, G Baker Hubbard, Mary Lou McGregor, Catherine O Jordan, Iason S Mantagos, Edward F Bell and 2 more

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Ophthalmology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02390531 (Phase 1 Trial of Bevacizumab Treatment for Severe Retinopathy of Prematurity), which is not on this map. Cited by 43 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
43citing papers in PubMed, 1 pooled it
8.8field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02390531 phase1completednot on this map

Phase 1 Trial of Bevacizumab Treatment for Severe Retinopathy of Prematurity

TypeinterventionalSponsorJaeb Center for Health ResearchRan2015 to 2021Enrolled120ConditionsRetinopathy of PrematurityArmsBevacizumab
3 · Its place in the literature

Who cites it

43 citing papers in PubMed, 1 synthesis or guideline pooled it, 108 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Review
  5. Review
  6. Review
  7. Efficacy comparison of anti-vascular endothelial growth factor drugs for the treatment of type 1 retinopathy of prematurity: A network meta-analysis of randomised controlled trials.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2024
    Review
  8. Article
  9. Comparing reactivation and retreatment for three doses of bevacizumab in type 1 retinopathy of prematurity.Journal of AAPOS : the official publication of the American Association for Pediatric Ophthalmology and Strabismus · 2024
    Article
  10. Article
  11. Article
  12. Article
  13. Article
  14. Article
  15. Systemic Cytokines in Retinopathy of Prematurity.Journal of personalized medicine · 2023
    Review
  16. Ocular and developmental outcomes of a dosing study of bevacizumab for retinopathy of prematurity.Journal of AAPOS : the official publication of the American Association for Pediatric Ophthalmology and Strabismus · 2023
    Article
  17. Review
  18. Structural and refractive outcomes of intravitreal ranibizumab followed by laser photocoagulation for type 1 retinopathy of prematurity.Journal of AAPOS : the official publication of the American Association for Pediatric Ophthalmology and Strabismus · 2022
    Article
  19. Article
  20. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors at 7 institutions in 1 country.

David K WallaceIndiana University, Indianapolis, Indiana. Electronic address: dwallac@iu.edu.
Trevano W DeanJaeb Center for Health Research, Tampa, Florida.
Mary Elizabeth HartnettJohn A. Moran Eye Center, Salt Lake City, Utah.
Lingkun KongTexas Tech University Health Science Center, Lubbock, Texas.
Lois E SmithBoston Children's Hospital, Harvard Medical School, Boston, Massachusetts.
G Baker HubbardThe Emory Eye Center, Atlanta, Georgia.
Mary Lou McGregorPediatric Ophthalmology Associates, Columbus, Ohio.
Catherine O JordanPediatric Ophthalmology Associates, Columbus, Ohio.
Iason S MantagosBoston Children's Hospital, Harvard Medical School, Boston, Massachusetts.
Edward F BellUniversity of Iowa, Iowa City, Iowa.
Raymond T KrakerJaeb Center for Health Research, Tampa, Florida.
Pediatric Eye Disease Investigator Group
Boston Children's Hospital · USJaeb Center for Health Research · USOphthalmology Associates (United States) · USEmory Eye Center · USIndiana University Health · USTexas Tech University · USUniversity of Iowa · US

Funding

Pediatric Eye Disease Investigator Group Coordinating CenterU10EY011751 · NEI · JAEB CENTER FOR HEALTH RESEARCH, INC. · PI KRAKER, RAYMOND · 1997 to 2018
$75.2M
Pediatric Eye Disease Investigator Group NetworkUG1EY011751 · NEI · JAEB CENTER FOR HEALTH RESEARCH, INC. · PI Raymond Kraker, Stacy Pineles · 2019 to 2026
$53.7M
Dietary control of angiogenesis in retinopathy modelsR01EY017017 · NEI · BOSTON CHILDREN'S HOSPITAL · PI Zhongjie Fu, Lois Smith · 2006 to 2026
$11.8M
Novel therapies to inhibit Diabetic RetinopathyR24EY024864 · NEI · UNIVERSITY OF CALIFORNIA-IRVINE · PI KERN, TIMOTHY S · 2015 to 2019
$8.1M
Mouse Neurodevelopmental Behavior CoreU54HD090255 · NICHD · BOSTON CHILDREN'S HOSPITAL · PI POMEROY, SCOTT LOREN · 2016 to 2020
$5.2M
Pediatric Eye Disease Investigator Group: Chair's OfficeU10EY018810 · NEI · MAYO CLINIC ROCHESTER · PI HOLMES, JONATHAN M · 2009 to 2013
$3.5M
PEDIATRIC EYE DISEASE INVESTIGATOR GROUP: CHAIR'S OFFICEU10EY023198 · NEI · INDIANA UNIVERSITY INDIANAPOLIS · PI WALLACE, DAVID K · 2014 to 2018
$1.4M
NEI NIH HHS R01 EY017017NEI NIH HHS R24 EY024864NEI NIH HHS U10 EY011751NEI NIH HHS U10 EY018810NEI NIH HHS U10 EY023198NEI NIH HHS UG1 EY011751NICHD NIH HHS U54 HD090255
6 · The paper itself

Abstract

purposeIntravitreal 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.

designMasked, multicenter, dose de-escalation study.

participantsA total of 61 premature infants with type 1 ROP.

methodsIf 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.

main outcome measuresEarly and late ROP recurrences, additional treatments, and structural outcomes after 6 months.

resultsOf 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.

conclusionsRetinal structural outcomes are very good after low-dose bevacizumab treatment for ROP, although many eyes received additional treatment.

Indexed as

Angiogenesis InhibitorsBevacizumabCombined Modality TherapyDouble-Blind MethodFemaleGestational AgeHumansInfantInfant, Low Birth WeightInfant, NewbornInfant, PrematureIntravitreal InjectionsLaser CoagulationMaleRecurrenceRetinaAngiogenesis InhibitorsBevacizumabVascular Endothelial Growth Factor AVEGFA protein, human

Identifiers

PMID29887334
PMCPMC6402322
OpenAlexW2807257299

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.