Evidence map›Paper›PMID 32617913›Full record

ArticleOphthalmology and therapy2020

A Multicenter, Retrospective Study (RE-ENACT 2) on Razumab™ (World's First Biosimilar Ranibizumab) in Retinal Vein Occlusion.

Shashikant Sharma, RE-ENACT 2 Study Investigators Group, Mujtaba Khan, Alok Chaturvedi

Abstract read
In one paragraph

Article in Ophthalmology and therapy, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed
–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.

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

19 citing papers in PubMed.

  1. Efficacy and Safety of Biosimilar Ranibizumab (OPTIMABClinical ophthalmology (Auckland, N.Z.) · 2024
    Trial
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  4. Review
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  6. Article
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  11. Ranizurel safety evaluation in real-world -(RaSER) study.American journal of ophthalmology case reports · 2022
    Article
  12. Future of anti-VEGF: biosimilars and biobetters.International journal of retina and vitreous · 2022
    Review
  13. Review
  14. Article
  15. Article
  16. 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

4 authors.

Shashikant SharmaMedical Services, Intas Pharmaceuticals Ltd., Ahmedabad, Gujarat, India. shashikant_sharma@intaspharma.com.ORCID http://orcid.org/0000-0001-8273-6270
RE-ENACT 2 Study Investigators Group
Mujtaba KhanMedical Services, Intas Pharmaceuticals Ltd., Ahmedabad, Gujarat, India.
Alok ChaturvediMedical Services, Intas Pharmaceuticals Ltd., Ahmedabad, Gujarat, India.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThe REal life assessmENt of safety And effeCTiveness of Razumab 2 (RE-ENACT 2) study evaluated the long-term effectiveness of biosimilar ranibizumab. We present the subgroup analysis of patients with retinal vein occlusion (RVO).

methodsData of patients who received pro re nata (PRN) biosimilar ranibizumab (November 2015 to December 2018, 17 centers) were analyzed. Endpoints were change from baseline in best corrected visual acuity (BCVA, Snellen's/logMAR), central subfield thickness (CSFT), intraocular pressure (IOP), and proportions of patients having intraretinal fluid (IRF) and subretinal fluid (SRF) at weeks 4, 8, 12, 16, 20, 24, 30, 36, and 48.

resultsOf 101 patients, 48.51% were men, and the majority (79.21%) were treatment naïve and had received 3 (range 1-5) injections (53.5%). Significant improvements (P < 0.05) were observed from baseline to all timepoints for BCVA [baseline, 0.89 ± 0.06 (n = 94); week 48, 0.41 ± 0.08 (n = 14)] and CSFT [baseline, 527.58 ± 19.9 (n = 85); week 48, 307.47 ± 16.4 (n = 15)]. Changes in IOP (mmHg) were non-significant [baseline, 15.38 ± 0.4 (n = 94); week 48, 13.94 ± 0.6 (n = 16); P = 0.5575). Proportions of patients having IRF [baseline, 71.3% (n = 84) vs week 48, 0% (n = 15)] and SRF [baseline, 52.5% (n = 83) vs week 48, 0% (n = 15)] were decreased. Similar results for BCVA, CSFT, IOP, IRF, and SRF were observed for BRVO and CRVO subgroups. There were no new safety concerns.

conclusionsBiosimilar ranibizumab demonstrated improvements in visual acuity and disease outcomes up to 48 weeks in patients with RVO without any new safety concerns.

Indexed as

Anti-VEGFBiosimilar ranibizumabRazumabRetinal vein occlusionRVO

Identifiers

PMID32617913
PMCPMC7406620

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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.