Evidence map›Paper›PMID 29945143›Full record

Observational studyOphthalmologica. Journal international d'ophtalmologie. International journal of ophthalmology. Zeitschrift fur Augenheilkunde2019

Real-Life Clinical Effectiveness of Razumab® (the World's First Biosimilar of Ranibizumab) in Retinal Vein Occlusion: A Subgroup Analysis of the Pooled Retrospective RE-ENACT Study.

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

Abstract readMulticenter StudyObservational Study
In one paragraph

Observational study in Ophthalmologica. Journal international d'ophtalmologie. International journal of ophthalmology. Zeitschrift fur Augenheilkunde, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 31 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed, 1 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.

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

31 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Peep into anti-vascular endothelial growth factor.Indian journal of ophthalmology · 2026
    Review
  4. Article
  5. Review
  6. Review
  7. Article
  8. Article
  9. Observational
  10. Development of Biosimilar Aflibercept SDZ-AFL.Current therapeutic research, clinical and experimental · 2025
    Review
  11. Article
  12. Review
  13. Article
  14. Review
  15. Ranizurel safety evaluation in real-world -(RaSER) study.American journal of ophthalmology case reports · 2022
    Article
  16. Article
  17. Future of anti-VEGF: biosimilars and biobetters.International journal of retina and vitreous · 2022
    Review
  18. Anti-VEGF and Other Novel Therapies for Neovascular Age-Related Macular Degeneration: An Update.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2021
    Review
  19. Review
  20. Article
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 Sharma
Mujtaba A Khan
Alok Chaturvedi
RE-ENACT Study Investigators Group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis subgroup analysis of the RE-ENACT study evaluates the effectiveness of Razumab® (the world's first biosimilar of ranibizumab by Intas Pharmaceuticals Ltd.) in Indian patients with retinal vein occlusion (RVO).

methodsThe data on patients with RVO who had received ≥3 injections of Razumab® between January and August 2016 were analyzed. Endpoints were: improvement in best corrected visual acuity (BCVA), and a decrease in central macular thickness (CMT), intraretinal fluid (IRF), and subretinal fluid (SRF) from baseline at weeks 4, 8, and 12.

resultsOf 160 patients, the majority (61.87%) were men. The mean (±SE) BCVA improved from baseline (0.76 ± 0.04) to week 4 (0.73 ± 0.03; p = 0.0656), which attained significance at week 8 (0.55 ± 0.02; p < 0.0001) and week 12 (0.47 ± 0.02; p < 0.0001). The mean (±SE) CMT significantly decreased from baseline (447.60 ± 10.91 μm) to week 4 (431.84 ± 10.92 μm; p = 0.0028), week 8 (339.28 ± 8.12 μm; p < 0.0001), and week 12 (298.23 ± 6.68 μm; p < 0.0001). The proportion of patients with IRF and SRF significantly (p < 0.0001) decreased from baseline to weeks 4, 8, and 12 (IRF: from 70.63 to 45.63, 39.38, and 30.00%, respectively; SRF: from 65.63 to 37.50, 28.13, and 24.38%, respectively). A subgroup analysis of branch RVO and central RVO showed similar results. No new safety concerns were observed.

conclusionRazumab® (biosimilar of ranibizumab) effectively improved visual acuity and disease outcomes in patients with RVO in a real-world setting with no new safety concerns.

Indexed as

Biosimilar PharmaceuticalsVisual AcuityAngiogenesis InhibitorsDose-Response Relationship, DrugFemaleFollow-Up StudiesHumansIntravitreal InjectionsMaleMiddle AgedRanibizumabRetinal Vein OcclusionRetrospective StudiesVascular Endothelial Growth Factor AAngiogenesis InhibitorsBiosimilar PharmaceuticalsRanibizumabVascular Endothelial Growth Factor ABiosimilarRanibizumabRazumab®Retinal vein occlusion

Identifiers

PMID29945143
PMCPMC6390449

What OpenQuestion holds

Textmetadata
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.