Evidence map›Paper›PMID 33742551›Full record

Trial reportActa ophthalmologica2022

Ranibizumab in retinopathy of prematurity - one-year follow-up of ophthalmic outcomes and two-year follow-up of neurodevelopmental outcomes from the CARE-ROP study.

Andreas Stahl, Marie-Christine Bründer, Wolf A Lagrèze, Fanni E Molnár, Teresa Barth, Nicole Eter, Rainer Guthoff, Tim U Krohne, Johanna M Pfeil, CARE-ROP Study Group

Open access · hybridAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Acta ophthalmologica, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed
3.6field-weighted citation impact, top 7% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 35 citations in OpenAlex.

  1. Trial
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  7. Anti-vascular endothelial growth factor therapies in ophthalmology.Medical hypothesis, discovery & innovation ophthalmology journal · 2025
    Review
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  10. 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
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  16. [Epidemiology and treatment of retinopathy of prematurity. The Hannover data in the Retina.net ROP registry from 2001-2017].Der Ophthalmologe : Zeitschrift der Deutschen Ophthalmologischen Gesellschaft · 2022
    Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 6 institutions in 2 countries.

Andreas StahlDepartment of Ophthalmology, University Medicine Greifswald, Greifswald, Germany.ORCID https://orcid.org/0000-0002-8013-7597
Marie-Christine BründerDepartment of Ophthalmology, University Medicine Greifswald, Greifswald, Germany.
Wolf A LagrèzeEye Center, Medical Center, Faculty of Medicine, University of Freiburg, Freiburg, Germany.ORCID https://orcid.org/0000-0002-3558-5905
Fanni E MolnárEye Center, Medical Center, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
Teresa BarthDepartment of Ophthalmology, University of Regensburg, Regensburg, Germany.
Nicole EterDepartment of Ophthalmology, University of Muenster Medical Center, Muenster, Germany.
Rainer GuthoffDepartment of Ophthalmology, Faculty of Medicine, University of Dusseldorf, Dusseldorf, Germany.
Tim U KrohneDepartment of Ophthalmology, Faculty of Medicine, University Hospital Cologne, University of Cologne, Cologne, Germany.
Johanna M PfeilDepartment of Ophthalmology, University Medicine Greifswald, Greifswald, Germany.ORCID https://orcid.org/0000-0002-2731-6094
CARE-ROP Study Group
Universitätsmedizin Greifswald · DEUniversity of Freiburg · DEApple (Israel) · ILDüsseldorf University Hospital · DEUniversity of Cologne · DEUniversity of Regensburg · DE

Funding

Dietary control of angiogenesis in retinopathy modelsR01EY017017 · NEI · BOSTON CHILDREN'S HOSPITAL · PI Zhongjie Fu, Lois Smith · 2006 to 2026
$11.8M
Glucose/lipid metabolism and vessel development in phase I ROPR01EY030904 · NEI · BOSTON CHILDREN'S HOSPITAL · PI SMITH, LOIS · 2020 to 2023
$1.7M
NEI NIH HHS R01 EY017017NEI NIH HHS R01 EY030904Novartis Pharma
6 · The paper itself

Abstract

purposeThe primary endpoint results from the comparing alternative ranibizumab dosages for safety and efficacy in retinopathy of prematurity (CARE-ROP) core study identified ranibizumab as an effective treatment to control acute retinopathy of prematurity (ROP). This study reports the 1- and 2-year follow-up data focusing on long-term functional outcomes and safety.

methodsThe CARE-ROP trial compared 0.12 mg versus 0.20 mg ranibizumab in 20 infants with ROP in a multicentric, prospective, randomized, double-blind, controlled study design. Sixteen patients entered the follow-up period. An ophthalmologic assessment at one year postbaseline was acquired from all 16 patients and a neurodevelopmental assessment at two years postbaseline was acquired from 15 patients.

resultsFifteen of 16 infants were able to fixate and follow moving objects at one year postbaseline treatment. One child progressed to stage 5 ROP bilaterally between the end of the core study and the 1-year follow-up (first seen at PMA 75 weeks). Mean spherical equivalents were -1.9 diopters (D) and -0.75 D in the 0.12 mg and the 0.20 mg treatment arms. Strabismus was present in seven and nystagmus in five out of 16 infants. Mental development scores were within normal limits in six out of ten patients with available data. No statistically significant difference was observed between the two treatment arms.

conclusionNeurodevelopmental and functional ocular outcomes 1 and 2 years after treatment with ranibizumab are reassuring regarding long-term safety. Late reactivation of ROP, however, represents a challenge during the follow-up phase and it is of utmost importance that regular follow-ups are maintained.

Indexed as

Angiogenesis InhibitorsBevacizumabDouble-Blind MethodFemaleFollow-Up StudiesGestational AgeHumansInfantInfant, NewbornIntravitreal InjectionsLaser CoagulationMaleNeurodevelopmental DisordersProspective StudiesRanibizumabRetinopathy of PrematurityAngiogenesis InhibitorsBevacizumabRanibizumabVascular Endothelial Growth Factor Aanti-vascular endothelial growth factorlong-term outcomesranibizumabretinopathy of prematurity

Identifiers

PMID33742551
PMCPMC9460412
OpenAlexW3137679820

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

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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.