Evidence map›Paper›PMID 33864599›Full record

ArticleOphthalmology and therapy2021

Real-World Safety Outcomes of Intravitreal Ranibizumab Biosimilar (Razumab) Therapy for Chorioretinal Diseases.

Debdulal Chakraborty, Michael W Stewart, Jay U Sheth, Tushar K Sinha, Subhendu Boral, Arnab Das, Soumen Mondal, Angshuman Mukherjee

Open access · goldAbstract read
In one paragraph

Article in Ophthalmology and therapy, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed
3.7field-weighted citation impact, top 6% 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

25 citing papers in PubMed, 27 citations in OpenAlex.

  1. Trial
  2. Review
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  6. Article
  7. Article
  8. Review
  9. Anti-vascular endothelial growth factor therapies in ophthalmology.Medical hypothesis, discovery & innovation ophthalmology journal · 2025
    Review
  10. Article
  11. Article
  12. Article
  13. Article
  14. Development of Biosimilar Aflibercept SDZ-AFL.Current therapeutic research, clinical and experimental · 2025
    Review
  15. Article
  16. Article
  17. Article
  18. Article
  19. Article
  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

8 authors at 3 institutions in 2 countries.

Debdulal ChakrabortyDepartment of Vitreoretinal Services, Disha Eye Hospitals, Kolkata, 700120, India. devdc@rediffmail.com.ORCID http://orcid.org/0000-0001-9693-7882
Michael W StewartDepartment of Ophthalmology, Mayo Clinic, Jacksonville, FL, USA.
Jay U ShethDepartment of Vitreoretinal Services, Surya Eye Institute and Research Center, Mumbai, India.
Tushar K SinhaDepartment of Vitreoretinal Services, Disha Eye Hospitals, Kolkata, 700120, India.
Subhendu BoralDepartment of Vitreoretinal Services, Disha Eye Hospitals, Kolkata, 700120, India.
Arnab DasDepartment of Vitreoretinal Services, Disha Eye Hospitals, Kolkata, 700120, India.
Soumen MondalDepartment of Vitreoretinal Services, Disha Eye Hospitals, Kolkata, 700120, India.
Angshuman MukherjeeDepartment of Vitreoretinal Services, Disha Eye Hospitals, Kolkata, 700120, India.
L V Prasad Eye Institute · INSurya Hospitals · INWinnMed · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionTo assess the safety profile of the intravitreal ranibizumab biosimilar molecule, Razumab

methodsThis was a multicenter, retrospective chart review which included patients from 15 centers receiving intravitreal Razumab (IVRz) injections from 2016 to 2020. Patient demographics, ocular examination data, and detailed safety information regarding serious adverse events (SAE) or serious adverse drug reactions (sADR), and non-serious AEs (nsAE) or non-serious ADRs (nsADR) occurring within 1 month of IVRz injections were compiled.

resultsA total of 6404 eyes of 6404 patients received 9406 IVRz injections [mean (± SD) = 1.49 (± 0.63)] during 4.25 years. Adverse events were reported after 1978 injections (21.03%): 64.16% nsAE, 32.96% nsADR, 2.37% sADR, and 0.51% SAE. The most frequent adverse events were subconjunctival hemorrhage (8.2% of total injections), transient blurring of vision (6.5% of total injections), and mild ocular pain (5.27% of total injections). Serious ocular (31 cases with retinal pigment epithelial tears [0.33%], two cases of non-infectious vitritis [0.02%], and one case of endophthalmitis [0.01%]) and systemic (seven patients with non-fatal myocardial infarction [0.12%] and six patients with non-fatal cerebrovascular accident [0.09%]) adverse events were infrequent.

conclusionThe study reports the largest pooled safety data on IVRz use in a real-world scenario. The results did not raise any new ocular or systemic safety concerns for the biosimilar agent, with the incidence and spectrum of adverse reactions similar to those reported with other anti-vascular endothelial growth factor (anti-VEGF) drugs. The real-world evidence suggests that IVRz is a safe anti-VEGF agent in the management of chorioretinal disorders.

Indexed as

Anti-vascular endothelial growth factorBiosimilarsRanibizumabRazumabSafety profile

Identifiers

PMID33864599
PMCPMC8079600
OpenAlexW3152641093

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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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.