Evidence map›Paper›PMID 31883056›Full record

ArticleOphthalmology and therapy2020

A Multicenter, Retrospective Study (RE-ENACT 2) on the Use of Razumab™ (World's First Biosimilar Ranibizumab) in Wet Age-Related Macular Degeneration.

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

Open access · goldAbstract 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, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 1 pooled it
4.8field-weighted citation impact, top 5% 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

19 citing papers in PubMed, 1 synthesis or guideline pooled it, 37 citations in OpenAlex.

  1. Pooled it
  2. Efficacy and Safety of Biosimilar Ranibizumab (OPTIMABClinical ophthalmology (Auckland, N.Z.) · 2024
    Trial
  3. Trial
  4. Article
  5. Review
  6. Review
  7. Review
  8. Article
  9. Ranizurel safety evaluation in real-world -(RaSER) study.American journal of ophthalmology case reports · 2022
    Article
  10. Future of anti-VEGF: biosimilars and biobetters.International journal of retina and vitreous · 2022
    Review
  11. Anti-VEGF and Other Novel Therapies for Neovascular Age-Related Macular Degeneration: An Update.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2021
    Review
  12. Review
  13. Article
  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 at 1 institution in 1 country.

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

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe REal life assessmENt of safety And effeCTiveness of Razumab (RE-ENACT) and long-term RE-ENACT 2 retrospective studies have evaluated the use of Razumab™ (world's first biosimilar ranibizumab) in retinal disorders in Indian patients. This report presents the subgroup analysis from the RE-ENACT 2 study in patients with wet age-related macular degeneration (wet AMD).

methodsMedical charts of patients administered biosimilar ranibizumab injections as PRN treatment regimen between September 2015 and June 2018, at 17 centers across India, were reviewed. Changes from baseline in best-corrected visual acuity (BCVA, based on Snellen's or logMAR chart), 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 were evaluated.

resultsOf 103 patients with wet AMD, 62.1% were men and the majority (74.8%) were treatment naïve. The majority (57.9%) of the patients had received 3 (range 1-5) injections. Significant improvements were observed from baseline to all timepoints for BCVA (baseline, 0.92 ± 0.6 [n = 94]; week 48, 0.51 ± 0.4 [n = 14]; P = 0.0014) and CSFT (baseline, 430.83 ± 14.4 [n = 85]; week 48, 301.26 ± 11.6 [n = 15]; P < 0.0001). Changes in IOP from baseline to 48 weeks were minimal and not significant (14.92 ± 3.2 [n = 94] vs. 14.50 ± 2.1 [n = 18]; P = 0.9068). A decrease in proportions of patients having IRF (baseline, 63.6% [n = 99] vs. week 48, 15% [n = 20]) and SRF (baseline, 82.3% [n = 96] vs. week 48, 5% [n = 20]) were also observed. Similar results were observed for occult and classic subgroups. There were no new safety concerns.

conclusionRazumab (biosimilar ranibizumab) demonstrated improvements in visual acuity and disease outcomes in patients with wet age-related macular degeneration without new safety issues.

Indexed as

Age-related macular degenerationAnti-VEGFBiosimilar ranibizumabWet AMD

Identifiers

PMID31883056
PMCPMC7054591
OpenAlexW2997462451

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.