Evidence map›Paper›PMID 38040965›Full record

ArticleEye (London, England)2024

Safety and tolerability of intravitreal umedaptanib pegol (anti-FGF2) for neovascular age-related macular degeneration (nAMD): a phase 1, open-label study.

Daniel S Pereira, Kazumasa Akita, Robert B Bhisitkul, Toshiaki Nishihata, Yusuf Ali, Emiko Nakamura, Yoshikazu Nakamura

Abstract readClinical Trial, Phase I
In one paragraph

Article in Eye (London, England), 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

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

6 citing papers in PubMed.

  1. Article
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  3. Review
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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

7 authors.

Daniel S PereiraRIBOMIC USA Inc, Berkeley, CA, USA.
Kazumasa AkitaRIBOMIC Inc., Minato-ku, Tokyo, Japan.
Robert B BhisitkulDepartment of Ophthalmology, University of California San Francisco, San Francisco, CA, USA.
Toshiaki NishihataRIBOMIC Inc., Minato-ku, Tokyo, Japan.
Yusuf AliRIBOMIC USA Inc, Berkeley, CA, USA.
Emiko NakamuraRIBOMIC USA Inc, Berkeley, CA, USA.
Yoshikazu NakamuraRIBOMIC Inc., Minato-ku, Tokyo, Japan. nak@ims.u-tokyo.ac.jp.ORCID http://orcid.org/0000-0001-8763-0424

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate the efficacy and safety of a single-dose intravitreal umedaptanib pegol (anti-FGF2, investigational new drug) for the treatment of neovascular age-related macular degeneration (nAMD).

methodsNine participants who had a diagnosis of refractory nAMD were enrolled and received a single intravitreal injection of umedaptanib pegol at increasing doses of 0.2, 1.0 or 2.0 mg in the study eye.

resultsAll three doses of umedaptanib pegol evaluated in the study were safe and well tolerated. No severe adverse event (AE) was observed in the study. There was an improvement in retinal fluid measured by central subfield thickness (CST) in most subjects. Remarkably, all three subjects who received 2.0 mg/eye showed improvement of more than 150 μm.

conclusionsIntravitreal umedaptanib pegol was safe, well tolerated, and demonstrated an indication of bioactivity in participants that have persistent subretinal fluid refractory to the treatment with anti-VEGFs.

Indexed as

Macular DegenerationAngiogenesis InhibitorsHumansIntravitreal InjectionsRetinaTreatment OutcomeWet Macular DegenerationAngiogenesis Inhibitors

Identifiers

PMID38040965
PMCPMC11009303

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