Evidence map›Paper›PMID 34011722›Full record

ArticleIndian journal of ophthalmology2021

Visual outcomes, safety profile and morphometric response of optical coherence tomography biomarkers to ranibizumab biosimilar treatment in neovascular age-related macular degeneration: Real-world evidence.

Aditya S Kelkar, Jai Kelkar, Mounika Bolisetty, Shreekant B Kelkar

Open access · diamondAbstract read
In one paragraph

Article in Indian journal of ophthalmology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed, 1 pooled it
0.6field-weighted citation impact, top 37% 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

1 citing paper in PubMed, 1 synthesis or guideline pooled it, 4 citations in OpenAlex.

  1. Pooled it
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.

Aditya S KelkarNational Institute of Ophthalmology, Pune, Maharashtra, India.
Jai KelkarNational Institute of Ophthalmology, Pune, Maharashtra, India.
Mounika BolisettyNational Institute of Ophthalmology, Pune, Maharashtra, India.
Shreekant B KelkarNational Institute of Ophthalmology, Pune, Maharashtra, India.
ICMR-National Institute of Virology · IN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Purpose: The aim of this study was to evaluate the safety, efficacy, and morphological response of intravitreal ranibizumab biosimilar (Razumab) in neovascular age-related macular degeneration (n-AMD) up to 12 weeks. Methods: Retrospective analysis of 20 eyes of n-AMD receiving 4 weekly intravitreal Razumab. Main outcome measures were mean change in best-corrected visual acuity (BCVA), intraretinal-fluid (IRF), subretinal-fluid (SRF), central-subfield thickness (CSFT), maximum central-retinal thickness (CRT), and dimensions of pigment epithelial detachment (PED) from baseline to weeks 4, 8 and 12. Results: Improvement in BCVA was seen at all visits, although not significantly (4 weeks: P = 0.18; 8 weeks: P = 0.4; 12 weeks: P = 0. 06). At 12 weeks, 90% of eyes either maintained or had an improvement in BCVA, with 40% of them showing an improvement of ≥3-lines and only 5% of them losing ≥3-lines of visual acuity. The median PED height and PED width reduced by 20.5 µm (P = 0.03) and 557.5 µm (P = 0.14), respectively, along with a mean reduction of 57.26 µmin CSFT (P < 0.001) and 44.15 µm in CRT (P = 0.004), respectively, at 12 weeks. On qualitative analysis, resolution of SRF and IRF was observed in 45% and 25% of eyes ' at 12 weeks. There were no serious ocular or systemic side effects identified. Conclusion: In real-world scenario, Razumab is an efficacious and economical anti-vascular endothelial growth factor (anti-VEGF) agent for optimal management of n-AMD. The therapeutic outcomes demonstrated reasonable stabilization and improvement in visual acuity, favorable anatomical outcomes pertaining to OCT-biomarkers with an acceptable safety profile.

Indexed as

Biosimilar PharmaceuticalsMacular DegenerationAngiogenesis InhibitorsBiomarkersHumansInfantIntravitreal InjectionsRanibizumabRetrospective StudiesTomography, Optical CoherenceTreatment OutcomeVascular Endothelial Growth Factor AAngiogenesis InhibitorsBiomarkersBiosimilar PharmaceuticalsRanibizumabVascular Endothelial Growth Factor AAge-related macular degenerationAnti-VEGFbiosimilarsoptical coherence tomographyRazumab

Identifiers

PMID34011722
PMCPMC8302301
OpenAlexW3162610903

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-SA
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.