Evidence map›Paper›PMID 30069864›Full record

Observational studyClinical drug investigation2018

Real-World Safety of Intravitreal Bevacizumab and Ranibizumab Treatments for Retinal Diseases in Thailand: A Prospective Observational Study.

Sermsiri Sangroongruangsri, Usa Chaikledkaew, Suthasinee Kumluang, Olivia Wu, Claudia Geue, Tanapat Ratanapakorn, Pattara Leelahavarong, Lily Ingsrisawang, Paisan Ruamviboonsuk, Wongsiri Taweebanjongsin and 7 more

Erratum issuedOpen access · hybridAbstract readMulticenter StudyObservational Study
In one paragraph

Observational study in Clinical drug investigation, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
1.5field-weighted citation impact, top 18% 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

7 citing papers in PubMed, 11 citations in OpenAlex.

  1. Article
  2. Article
  3. Review
  4. Article
  5. Article
  6. Observational
  7. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

17 authors at 10 institutions in 2 countries.

Sermsiri SangroongruangsriSocial and Administrative Pharmacy Excellence Research (SAPER) Unit, Department of Pharmacy, Faculty of Pharmacy, Mahidol University, 447 Sri-Ayuthaya Road, Rajathevi, Bangkok, 10400, Thailand.
Usa ChaikledkaewSocial and Administrative Pharmacy Excellence Research (SAPER) Unit, Department of Pharmacy, Faculty of Pharmacy, Mahidol University, 447 Sri-Ayuthaya Road, Rajathevi, Bangkok, 10400, Thailand. usa.chi@mahidol.ac.th.ORCID http://orcid.org/0000-0001-9457-9823
Suthasinee KumluangHealth Intervention and Technology Assessment Program, Ministry of Public Health, Nonthaburi, Thailand.
Olivia WuInstitute of Health and Wellbeing, University of Glasgow, Glasgow, UK.
Claudia GeueInstitute of Health and Wellbeing, University of Glasgow, Glasgow, UK.
Tanapat RatanapakornDepartment of Ophthalmology, Khon Kaen University, Khon Kaen, Thailand.
Pattara LeelahavarongHealth Intervention and Technology Assessment Program, Ministry of Public Health, Nonthaburi, Thailand.
Lily IngsrisawangDepartment of Statistics, Faculty of Science, Kasetsart University, Bangkok, Thailand.
Paisan RuamviboonsukDepartment of Ophthalmology, Faculty of Medicine, Rajavithi Hospital, Rangsit University, Bangkok, Thailand.
Wongsiri TaweebanjongsinMettapracharak Eye Institute, Mettapracharak (Wat Rai Khing) Hospital, Nakhon Pathom, Thailand.
Janejit ChoovuthayakornDepartment of Ophthalmology, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.
Apichart SingalavanijaDepartment of Ophthalmology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.
Prut HanutsahaDepartment of Ophthalmology, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.
Kittisak KulvichitDepartment of Ophthalmology, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.
Thitiporn RatanapojnardDepartment of Ophthalmology, Phramongkutklao Hospital, Phramongkutklao College of Medicine, Bangkok, Thailand.
Warapat WongsawadMettapracharak Eye Institute, Mettapracharak (Wat Rai Khing) Hospital, Nakhon Pathom, Thailand.
Yot TeerawattananonHealth Intervention and Technology Assessment Program, Ministry of Public Health, Nonthaburi, Thailand.
Mahidol University · THMinistry of Public Health · THUniversity of Glasgow · GBChiang Mai University · THChulalongkorn University · THKasetsart University · THKhon Kaen University · THPhramongkutklao Hospital · THRajavithi Hospital · THSiriraj Hospital · TH

Funding

Bill and Melinda Gates Foundation OPP1134345Health Systems Research Institute (HSRI) 57-026Health Systems Research Institute (HSRI) 59-005Royal Golden Jubilee Ph.D. Program provided by the Thailand Research Fund (TRF) and Mahidol University PHD/0180/2554Thailand Research Fund (TRF) under a grant for Senior Research Scholar RTA5980011
6 · The paper itself

Abstract

backgroundThere is very limited evidence examining serious systemic adverse events (SSAEs) and post-injection endophthalmitis of intravitreal bevacizumab (IVB) and intravitreal ranibizumab (IVR) treatments in Thailand and low- and middle-income countries. Moreover, findings from the existing trials might have limited generalizability to certain populations and rare SSAEs.

objectivesThis prospective observational study aimed to assess and compare the safety profiles of IVB and IVR in patients with retinal diseases in Thailand.

methodsBetween 2013 and 2015, 6354 patients eligible for IVB or IVR were recruited from eight hospitals. Main outcomes measures were prevalence and risk of SSAEs, mortality, and endophthalmitis during the 6-month follow-up period.

resultsIn the IVB and IVR groups, 94 and 6% of patients participated, respectively. The rates of outcomes in the IVB group were slightly greater than in the IVR group. All-cause mortality rates in the IVB and IVR groups were 1.10 and 0.53%, respectively. Prevalence rates of endophthalmitis and non-fatal strokes in the IVB group were 0.04% of 16,421 injections and 0.27% of 5975 patients, respectively, whereas none of these events were identified in the IVR group. There were no differences between the two groups in the risks of mortality, arteriothrombotic events (ATE), and non-fatal heart failure (HF). Adjustment for potential confounding factors and selection bias using multivariable models for time-to-event outcomes and propensity scores did not alter the results.

conclusionsThe rates of SAEs in both groups were low. The IVB and IVR treatments were not associated with significant risks of mortality, ATE, and non-fatal HF.

trial registrationThai Clinical Trial Registry identifier TCTR20141002001.

Indexed as

Angiogenesis InhibitorsBevacizumabRanibizumabRetinal DiseasesAgedAged, 80 and overFemaleFollow-Up StudiesHumansIntravitreal InjectionsMaleMiddle AgedProspective StudiesThailandThrombosisTreatment OutcomeAngiogenesis InhibitorsBevacizumabRanibizumab

Identifiers

PMID30069864
PMCPMC6153972
OpenAlexW2885320439

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

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.