Evidence map›Paper›PMID 40668667›Full record

Trial reportRetina (Philadelphia, Pa.)2025

IMPACT OF FARICIMAB VERSUS AFLIBERCEPT ON EPIRETINAL MEMBRANE FORMATION OVER 2 YEARS IN PATIENTS WITH DIABETIC MACULAR EDEMA IN THE PHASE 3 YOSEMITE AND RHINE TRIALS.

Glenn J Jaffe, Gábor Deák, Kara Gibson, Rahul N Khurana, Eric Nudleman, Yuichiro Ogura, Ursula Schmidt-Erfurth, Tracey Wang, Peter D Westenskow, David Wong and 2 more

2 registry-linked trialsAbstract readRandomized Controlled TrialClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in Retina (Philadelphia, Pa.), 2025. 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 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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

4 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. 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

12 authors.

Glenn J JaffeDepartment of Ophthalmology, Duke University, Durham, North Carolina.
Gábor DeákDepartment of Ophthalmology and Optometry, Medical University of Vienna, Vienna, Austria.
Kara GibsonRoche Products Ltd., Welwyn Garden City, United Kingdom.
Rahul N KhuranaNorthern California Retina Vitreous Associates, Mountain View, California.
Eric NudlemanShiley Eye Institute at UC San Diego Health, La Jolla, California.
Yuichiro OguraDepartment of Ophthalmology and Visual Science, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.
Ursula Schmidt-ErfurthDepartment of Ophthalmology and Optometry, Medical University of Vienna, Vienna, Austria.
Tracey WangF. Hoffmann-La Roche Ltd., Mississauga, Ontario, Canada.
Peter D WestenskowF. Hoffmann-La Roche Ltd., Basel, Switzerland.
David WongDepartment of Ophthalmology and Vision Sciences, Unity Health Toronto - St. Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.
Glenn YiuDepartment of Ophthalmology and Vision Science, University of California, Davis Health, Sacramento, California; and.
Jeffrey R WillisGenentech, Inc., South San Francisco, California.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

background/purposeTo assess the effects of faricimab versus aflibercept on epiretinal membrane (ERM) formation in eyes with diabetic macular edema.

methodsPost hoc analysis of phase 3 YOSEMITE/RHINE trial data in eyes with diabetic macular edema receiving faricimab every 8 weeks (Q8W), faricimab treat-and-extend (T&E; up to Q16W depending on central subfield thickness and best-corrected visual acuity), or aflibercept Q8W for 100 weeks.

resultsERMs developed in 3.8% (23/602) of eyes treated with faricimab Q8W, 5.1% (31/608) with faricimab T&E, and 7.6% (45/590) with aflibercept Q8W at 100 weeks. ERMs were less likely with faricimab Q8W versus aflibercept Q8W (odds ratio [OR] 0.48, 95% confidence interval [CI] 0.29-0.81, P = 0.0055). The mean (SD) best-corrected visual acuity at 100 weeks in eyes with and without ERMs were 69.2 (13.6) letters [20/40 Snellen] versus 73.8 (13.1) [20/40 Snellen], respectively; the mean (SD) CSTs were 315.8 (99.2) versus 274.6 (74.1) µ m. Faricimab T&E dosing intervals were extended ≥ Q12W in 79.7% of eyes without ERMs versus 50.0% with ERMs.

conclusionRisk of ERMs was 52% lower with faricimab Q8W versus aflibercept Q8W over 100 weeks in eyes with diabetic macular edema, suggesting a potential role for faricimab in reducing pre-retinal fibrotic proliferation. The results may help inform physician/patient decision-making when initiating intravitreal therapy.

trial registrationNCT03622580 and NCT03622593.

Indexed as

Diabetic RetinopathyEpiretinal MembraneMacular EdemaReceptors, Vascular Endothelial Growth FactorRecombinant Fusion ProteinsVisual AcuityAgedAngiogenesis InhibitorsAntibodies, BispecificDouble-Blind MethodFemaleFollow-Up StudiesHumansIntravitreal InjectionsMacula LuteaMaleafliberceptAngiogenesis InhibitorsAntibodies, BispecificfaricimabReceptors, Vascular Endothelial Growth FactorRecombinant Fusion ProteinsVascular Endothelial Growth Factor Aangiopoietin-2diabetic macular edemaepiretinal membranefaricimabvascular endothelial growth factor-A

Identifiers

PMID40668667
PMCPMC12548813

What OpenQuestion holds

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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.