Evidence map›Paper›PMID 24868458›Full record

ArticleJournal of ophthalmology2014

A 2-Year, Phase IV, Multicentre, Observational Study of Ranibizumab 0.5 mg in Patients with Neovascular Age-Related Macular Degeneration in Routine Clinical Practice: The EPICOHORT Study.

Sergio Pagliarini, Stephen Beatty, Blandina Lipkova, Eduardo Perez-Salvador Garcia, Stefaan Reynders, Margarita Gekkieva, Abdelkader Si Bouazza, Stefan Pilz

Abstract read
In one paragraph

Article in Journal of ophthalmology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 6 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

19 citing papers in PubMed, 6 syntheses or guidelines pooled it.

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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

8 authors.

Sergio PagliariniDepartment of Ophthalmology, University Hospitals Coventry & Warwickshire NHS Trust, Coventry, West Midlands CV2 2DX, UK.ORCID 0000-0003-3839-7851
Stephen BeattyInstitute of Eye Surgery and Macular Pigment Research Group, Whitfield Eye Clinic, Waterford, Ireland.
Blandina LipkovaDepartment of Ophthalmology, Faculty Hospital, Vojtecha Spanyola 43, 012 07 Zilina, Slovakia.ORCID 0000-0002-5754-7547
Eduardo Perez-Salvador GarciaHospital Provincial Divino Valles, Avenida Islas Baleares 1, 09006 Burgos, Spain.
Stefaan ReyndersOogcentrum Oostende, Koninginnelaan 54, 8400 Oostende, Belgium.
Margarita GekkievaNovartis Pharma AG, CH-4002 Basel, Switzerland.ORCID 0000-0003-1043-4382
Abdelkader Si BouazzaNovartis Pharma AG, CH-4002 Basel, Switzerland.
Stefan PilzNovartis Pharma AG, CH-4002 Basel, Switzerland.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Purpose. To assess the safety profile of ranibizumab 0.5 mg in patients with neovascular age-related macular degeneration (nAMD) in routine clinical practice. Methods. This 2-year, multicentre, observational study was conducted to capture real-world early practice and outcomes across Europe, shortly after European licensing of ranibizumab for nAMD. Being observational in nature, the study did not impose diagnostic/therapeutic interventions/visit schedule. Patients were to be treated as per the EU summary of product characteristics (SmPC) in effect during the study. Key outcome measures were incidence of selected adverse events (AEs), treatment exposure, bilateral treatment, compliance to the EU SmPC, and best-corrected visual acuity (BCVA) over 2 years. Results. 755 of 770 patients received treatment. Ranibizumab was generally well tolerated with low incidence of selected AEs (0%-1.9%). Patients received 6.2 (mean) injections and 133 patients received bilateral treatment over 2 years. Protocol deviation to treatment compliance was reported in majority of patients. The observed decline in mean BCVA (Month 12, +1.5; Month 24, -1.3 letters) may be associated with undertreatment as suggested by BCVA subgroup analysis. Conclusion. The EPICOHORT study conducted in routine clinical practice reinforces the well-established safety profile of ranibizumab in nAMD. In early European practice it appeared that the nAMD patients were undertreated.

Identifiers

PMID24868458
PMCPMC4020221

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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.