Evidence map›Paper›PMID 38831127›Full record

ArticleOphthalmology and therapy2024

Real-World Outcomes of a Loading Phase with Intravitreal Faricimab in Neovascular Age-Related Macular Degeneration (n-AMD) and Diabetic Macular Edema (DME).

Ermete Giancipoli, Antonella Guglielmi, Anna Valeria Bux, Giulia Maria Emilia Clima, Francesco Pignatelli, Francesco Boscia, Pasquale Viggiano, Giacomo Boscia, Francesca Fortunato, Gianluca Besozzi and 3 more

Registry-linked trialAbstract read
In one paragraph

Article in Ophthalmology and therapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06572553 (Evaluation of Therapeutic Efficacy of Faricimab for Clinical AMD, DME, and RVO Patients), which is not on this map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 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.

NCT06572553 phase2 / phase3unknown statusnot on this map

Evaluation of Therapeutic Efficacy of Faricimab for Clinical AMD, DME, and RVO Patients

TypeinterventionalSponsorSecond Affiliated Hospital, Zhejiang University, School of MedicineRan2024 to 2024Enrolled30ConditionsAge-Related Macular Degeneration, Diabetic Macular Edema, Retinal Vein OcclusionArmsFaricimab
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Observational
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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.

Ermete Giancipoli *Department of Ophthalmology, Policlinico Riuniti Foggia, University of Foggia, 71122, Foggia, Italy.
Antonella Guglielmi *Department of Ophthalmology, Policlinico Riuniti Foggia, University of Foggia, 71122, Foggia, Italy. antonella_guglielmi@hotmail.it.ORCID http://orcid.org/0009-0000-6465-0449
Anna Valeria BuxDepartment of Ophthalmology, Policlinico Riuniti Foggia, University of Foggia, 71122, Foggia, Italy.
Giulia Maria Emilia ClimaDepartment of Ophthalmology, Policlinico Riuniti Foggia, University of Foggia, 71122, Foggia, Italy.
Francesco PignatelliEye Clinic, "SS. Annunziata" Hospital, ASL Taranto, Taranto, Italy.
Francesco BosciaDepartment of Translational Biomedicine Neuroscience, University of Bari "Aldo Moro", 70125, Bari, Italy.
Pasquale ViggianoDepartment of Translational Biomedicine Neuroscience, University of Bari "Aldo Moro", 70125, Bari, Italy.
Giacomo BosciaDepartment of Translational Biomedicine Neuroscience, University of Bari "Aldo Moro", 70125, Bari, Italy.
Francesca FortunatoHygiene Unit, Department of Medical and Surgical Sciences, Policlinico Foggia Hospital, University of Foggia, Foggia, Italy.
Gianluca BesozziDepartment of Ophthalmology, Vito Fazzi Hospital, 34408, Lecce, Italy.
Alfredo NiroEye Clinic, "SS. Annunziata" Hospital, ASL Taranto, Taranto, Italy.
Stefano DoreDepartment of Medical, Surgical and Experimental Sciences, University of Sassari, Sassari, Italy.
Cristiana IaculliDepartment of Ophthalmology, Policlinico Riuniti Foggia, University of Foggia, 71122, Foggia, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe aims of this work were to evaluate the real-world efficacy and safety of a loading dose of intravitreal faricimab in eyes with active neovascular age-related macular degeneration (n-AMD) or diabetic macular edema (DME) and to analyze the treatment outcome in relation to specific biomarkers.

methodsPatients with active n-AMD or DME, treated with four monthly intravitreal injections of faricimab, were enrolled in this retrospective, uncontrolled study. Best-corrected visual acuity (BCVA), central subfield thickness (CST), presence of retinal fluid (RF) on optical coherence tomography (OCT), and adverse events were assessed at baseline and at weeks 4, 8, 12, and 16. Predefined biomarkers were evaluated at baseline (BL) and at last visit.

resultsSixteen eyes of 15 patients with n-AMD (n-AMD group) and 15 eyes of 12 patients with DME (DME group) were included. Mean (± standard deviation) logarithm of minimum angle of resolution (logMAR) BL BCVA changed from 0.68 (± 0.43) to 0.53 (± 0.36; P = 0.13) and from 0.51 (± 0.34) to 0.32 (± 0.24; P: 0.048) at week 16 in n-AMD and DME group, respectively. A statistically significant mean CST reduction was reported in both groups at last visit (n-AMD: - 166.5 μm; P = 0.0009/DME: - 110.8 μm; P = 0.0086). Seventy-five and 33% of eyes with n-AMD and DME respectively achieved complete RF resolution at last visit. Subfoveal inner and outer retinal damage correlated with a lower final BCVA in n-AMD group. The presence of large (> 100 μm) juxtafoveal microaneurysms (MAs) was significantly correlated with a higher chance of residual fluid in eyes with DME.

conclusionsBoth n-AMD and DME groups achieved satisfactory anatomical results after a loading-dose of intravitreal faricimab. BCVA improvement might be hampered by pre-existing retinal damage in eyes with n-AMD. Large, juxtafoveal MAs might represent a hallmark of a slower anatomical response to the treatment in eyes with DME.

Indexed as

Anti-vascular endothelial growth factor (anti-VEGF)BiomarkersDiabetic macular edema (DME)Dual inhibitionFaricimabLoading phaseNeovascular age-related macular degeneration (n-AMD)

Identifiers

PMID38831127
PMCPMC11246372

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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.