Evidence map›Paper›PMID 40496217›Full record

ArticleOphthalmology science

Effect of Faricimab versus Aflibercept on Hyperreflective Foci in Patients with Diabetic Macular Edema from the YOSEMITE/RHINE Trials.

Usha Chakravarthy, Varun Chaudhary, Srinivas R Sadda, Colin S Tan, Stela Vujosevic, Sascha Fauser, Kara Gibson, Carl Glittenberg, Nancy Holekamp, Ben Lanza and 3 more

2 registry-linked trialsAbstract read
In one paragraph

Article in Ophthalmology science. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing 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.

NCT03622580 phase3completednot on this map

A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Patients With Diabetic Macular Edema (YOSEMITE)

TypeinterventionalSponsorHoffmann-La RocheRan2018 to 2021Enrolled940ConditionsDiabetic Macular EdemaArmsAflibercept, Faricimab, Sham Procedure
NCT03622593 phase3completednot on this map

A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Patients With Diabetic Macular Edema (RHINE)

TypeinterventionalSponsorHoffmann-La RocheRan2018 to 2023Enrolled951ConditionsDiabetic Macular EdemaArmsAflibercept, Faricimab, Sham Procedure
3 · Its place in the literature

Who cites it

8 citing papers in PubMed.

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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

13 authors.

Usha ChakravarthyCentre for Public Health, Queen's University of Belfast, Belfast, UK.
Varun ChaudharyDepartment of Surgery, Hamilton Regional Eye Institute, McMaster University, Hamilton, Ontario, Canada.
Srinivas R SaddaDoheny Eye Institute, Pasadena, California.
Colin S TanNational Healthcare Group Eye Institute, Tan Tock Seng Hospital, Singapore.
Stela VujosevicDepartment of Biomedical Surgical and Dental Sciences, University of Milan, Milan, Italy.
Sascha FauserF. Hoffmann-La Roche Ltd., Basel, Switzerland.
Kara GibsonRoche Products Ltd., Welwyn Garden City, UK.
Carl GlittenbergF. Hoffmann-La Roche Ltd., Basel, Switzerland.
Nancy HolekampF. Hoffmann-La Roche Ltd., Basel, Switzerland.
Ben LanzaRoche Products Ltd., Welwyn Garden City, UK.
Andreas MaunzF. Hoffmann-La Roche Ltd., Basel, Switzerland.
Jeffrey R WillisGenentech, Inc., South San Francisco, California.
Rishi P SinghCenter for Ophthalmic Bioinformatics, Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Purpose: To compare the effect of faricimab, a dual angiopoietin-2 (Ang-2) and VEGF-A inhibitor, with aflibercept on resolution of hyperreflective foci (HRF) in patients with diabetic macular edema (DME). Design: A post hoc analysis of the randomized, double-masked, noninferiority YOSEMITE/RHINE (NCT03622580/NCT03622593) phase III trials. Participants: Adults with vision loss due to center-involving DME. Methods: A deep learning-based algorithm was used to automatically quantify HRF in spectral-domain OCT volume scans from YOSEMITE/RHINE. Study eyes were randomized to faricimab 6.0 mg every 8 weeks (Q8W; n = 519), faricimab 6.0 mg according to a personalized treat-and-extend (T&E)-based regimen (n = 524), and aflibercept 2.0 mg Q8W (n = 502). Hyperreflective foci were defined as hyperreflective objects up to 50 μm in diameter and assessed within the 1.0-mm and 3.0-mm-diameter ETDRS rings and by location within the inner and outer retina. Main Outcome Measures: Hyperreflective foci volume and count at baseline and over time through week 48 in the inner, outer, and total retina, 1-mm and 3-mm diameters; time to absence of HRF at 2 consecutive visits in the inner and outer retina, 1-mm diameter over 48 weeks. Results: Adjusted mean HRF volumes at week 48 were lower for faricimab Q8W (104.1 picoliter [pL]) and faricimab T&E (110.1 pL) compared with aflibercept (180.3 pL; nominal Conclusions: Greater HRF reductions were achieved with faricimab versus aflibercept, supporting the therapeutic potential of dual Ang-2/VEGF-A inhibition to suppress disease activity in DME. Financial Disclosures: Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Indexed as

Angiopoietin-2Diabetic macular edemaFaricimabHyperreflective fociVEGF

Identifiers

PMID40496217
PMCPMC12149427

What OpenQuestion holds

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Read underepoch 390

Registered trials

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.