Evidence map›Paper›PMID 32714608›Full record

ArticleJournal of ophthalmology2020

Safety of Intravitreal Injection of Biosimilar of Aflibercept in Rabbit Eyes.

Alireza Lashay, Hamid Riazi-Esfahani, Hooshang Faghihi, Ahmad Mirshahi, Hassan Khojasteh, Alireza Khodabande, Fahimeh Asadi Amoli, Fariba Ghassemi, Fatemeh Bazvand, Elias Khalili Pour and 3 more

Open access · goldAbstract read
In one paragraph

Article in Journal of ophthalmology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.3field-weighted citation impact, top 42% 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

3 citing papers in PubMed, 3 citations in OpenAlex.

  1. Trial
  2. Article
  3. In vitro and in ovo experimental study of two anti-VEGF agents used in ophthalmology.Romanian journal of morphology and embryology = Revue roumaine de morphologie et embryologie
    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

13 authors at 1 institution in 1 country.

Alireza LashayEye Research Center, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran.
Hamid Riazi-EsfahaniEye Research Center, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran.ORCID https://orcid.org/0000-0003-2277-398X
Hooshang FaghihiEye Research Center, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran.ORCID https://orcid.org/0000-0001-9371-4915
Ahmad MirshahiEye Research Center, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran.
Hassan KhojastehEye Research Center, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran.ORCID https://orcid.org/0000-0001-9407-5764
Alireza KhodabandeEye Research Center, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran.
Fahimeh Asadi AmoliEye Research Center, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran.
Fariba GhassemiEye Research Center, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran.
Fatemeh BazvandEye Research Center, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran.
Elias Khalili PourEye Research Center, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran.
Nazanin EbrahimiadibEye Research Center, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran.
Ali TorkashvandEye Research Center, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran.
Elham DelrishEye Research Center, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran.
Farabi Hospital · IR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo assess the safety of biosimilar intravitreal aflibercept (CinnaGen Co., Iran) compared to the reference product (Eylea®; Bayer Schweiz AG, Zurich, Switzerland) in rabbit eyes through functional and histologic studies.

methodsForty New Zealand albino rabbits were recruited to the study and were divided into four groups to be sacrificed at 48 hours, one, two, and four weeks after injections. In each group, five rabbits received 0.05 mL (2 mg) biosimilar aflibercept in the right eye and 0.05 mL saline in the left eye as the control, and in a similar manner, the remaining five rabbits received the reference drug in the right eye and saline in the left eye. All the rabbits underwent comprehensive ophthalmic examination and electroretinography (ERG) tests at baseline and also just before enucleation at the specific predefined time points. The enucleated eyes were prepared for retinal toxicity histological examination.

resultsNo retinal toxicity was observed based on histologic and ERG findings in all groups. Choroidal congestion was revealed after 1 week in an eye that was injected with biosimilar aflibercept, although the similar finding was detected in the contralateral eye which received saline. Also, one subject which received the reference drug showed chronic vitritis and lymphoplasmocytic reaction of the optic disc at week 4. The remaining subjects showed no histologic changes.

conclusionThe 2 mg intravitreal injection of biosimilar aflibercept (CinnaGen Co., Iran) was found to be nontoxic in rabbit eyes in the short-term period. Further studies are required to warrant the efficacy and safety profile of the drug in human subjects.

Identifiers

PMID32714608
PMCPMC7354659
OpenAlexW3040588017

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Registered trials

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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.