Evidence map›Paper›PMID 32324197›Full record

Trial reportJAMA ophthalmology2020

Short-term Outcomes After Very Low-Dose Intravitreous Bevacizumab for Retinopathy of Prematurity.

David K Wallace, Raymond T Kraker, Sharon F Freedman, Eric R Crouch, Amit R Bhatt, M Elizabeth Hartnett, Michael B Yang, David L Rogers, Amy K Hutchinson, Deborah K VanderVeen and 11 more

Registry-linked trialAbstract readClinical Trial, Phase IMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in JAMA ophthalmology, 2020. 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 27 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 2 pooled it
–field-weighted citation impact
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

27 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Article
  4. 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
  5. 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
  6. Review
  7. 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
  8. Article
  9. Review
  10. Article
  11. Article
  12. Article
  13. Review
  14. Retinopathy of prematurity classification updates: possible implications for treatment.Journal of AAPOS : the official publication of the American Association for Pediatric Ophthalmology and Strabismus · 2022
    Article
  15. Article
  16. World Prematurity Day: it takes an NIH village to prevent preterm birth and improve treatments for preterm infants.American journal of physiology. Lung cellular and molecular physiology · 2021
    Article
  17. Review
  18. Review
  19. Article
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

21 authors.

David K WallaceIndiana University Department of Ophthalmology, Indianapolis.
Raymond T KrakerJaeb Center for Health Research, Tampa, Florida.
Sharon F FreedmanDuke Eye Center, Durham, North Carolina.
Eric R CrouchEastern Virginia Medical School, Norfolk.
Amit R BhattTexas Children's Hospital, Houston.
M Elizabeth HartnettJohn A. Moran Eye Center, Salt Lake City, Utah.
Michael B YangCincinnati Children's Hospital Medical Center, Cincinnati, Ohio.
David L RogersPediatric Ophthalmology Associates Inc, Columbus, Ohio.
Amy K HutchinsonEmory University School of Medicine, Atlanta, Georgia.
Deborah K VanderVeenBoston Children's Hospital, Boston, Massachusetts.
Kathryn M HaiderIndiana University Department of Ophthalmology, Indianapolis.
R Michael SiatkowskiDean McGee Eye Institute, University of Oklahoma, Oklahoma City.
Trevano W DeanJaeb Center for Health Research, Tampa, Florida.
Roy W BeckJaeb Center for Health Research, Tampa, Florida.
Michael X RepkaWilmer Eye Institute, Baltimore, Maryland.
Lois E SmithEmory University School of Medicine, Atlanta, Georgia.
William V GoodSmith-Kettlewell Eye Research Institute, San Francisco, California.
Lingkun KongBaylor College of Medicine, Houston, Texas.
Susan A CotterSouthern California College of Optometry at Marshall B. Ketchum University, Fullerton.
Jonathan M HolmesMayo Clinic, Rochester, Minnesota.
Pediatric Eye Disease Investigator Group (PEDIG)

Funding

Mechanisms of Angiogenesis of Retinopathy of PrematurityR01EY015130 · NEI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Mary Elizabeth Ruth Hartnett · 2005 to 2026
$7.6M
NEI NIH HHS R01 EY015130
6 · The paper itself

Abstract

Importance: Intravitreous bevacizumab (0.25 mg to 0.625 mg) is commonly used to treat type 1 retinopathy of prematurity (ROP), but there are concerns about systemic toxicity, particularly the risk of neurodevelopmental delay. A much lower dose may be effective for ROP while reducing systemic risk. Previously, after testing doses of 0.25 mg to 0.031 mg, doses as low as 0.031 mg were found to be effective in small cohorts of infants. Objective: To find the lowest dose of intravitreous bevacizumab effective for severe ROP. Design, Setting, and Participants: Between April 2017 and May 2019, 59 premature infants with type 1 ROP in 1 or both eyes were enrolled in a masked, multicenter, dose de-escalation study. In cohorts of 10 to 14 infants, 1 eye per infant received 0.016 mg, 0.008 mg, 0.004 mg, or 0.002 mg of intravitreous bevacizumab. Diluted bevacizumab was prepared by individual research pharmacies and delivered using 300-µL syringes with 5/16-inch, 30-guage fixed needles. Analysis began July 2019. Interventions: Bevacizumab intravitreous injections at 0.016 mg, 0.008 mg, 0.004 mg, or 0.002 mg. Main Outcomes and Measures: Success was defined as improvement by 4 days postinjection and no recurrence of type 1 ROP or severe neovascularization requiring additional treatment within 4 weeks. Results: Fifty-five of 59 enrolled infants had 4-week outcomes completed; the mean (SD) birth weight was 664 (258) g, and the mean (SD) gestational age was 24.8 (1.6) weeks. A successful 4-week outcome was achieved for 13 of 13 eyes (100%) receiving 0.016 mg, 9 of 9 eyes (100%) receiving 0.008 mg, 9 of 10 eyes (90%) receiving 0.004 mg, but only 17 of 23 eyes (74%) receiving 0.002 mg. Conclusions and Relevance: These data suggest that 0.004 mg may be the lowest dose of bevacizumab effective for ROP. Further investigation is warranted to confirm effectiveness of very low-dose intravitreous bevacizumab and its effect on plasma vascular endothelial growth factor levels and peripheral retinal vascularization.

Indexed as

Angiogenesis InhibitorsBevacizumabDose-Response Relationship, DrugFemaleFollow-Up StudiesHumansInfantInfant, NewbornIntravitreal InjectionsMaleReceptors, Vascular Endothelial Growth FactorRetinaRetinopathy of PrematurityTreatment OutcomeAngiogenesis InhibitorsBevacizumabReceptors, Vascular Endothelial Growth Factor

Identifiers

PMID32324197
PMCPMC7180729

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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.