---
title: "Faricimab for Diabetic Macular Edema: Anatomical Response vs Visual Recovery in Naïve and Refracto"
id: "plos-one-1-use-of-faricimab-for-refractory-diabetic-macular-edema-in-real-world-clinical"
canonical_url: "https://medichelpline.com/clinical-feed/plos-one-1-use-of-faricimab-for-refractory-diabetic-macular-edema-in-real-world-clinical"
content_type: "clinical_feed_article"
specialty: "General"
source_name: "PLOS ONE (Medicine)"
source_url: "https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0358993"
published_at: "2026-09-23T14:00:00.000Z"
evidence_level: "Journal Feed"
license: "CC-BY-NC-4.0 / Informational Use"
---
# Faricimab for Diabetic Macular Edema: Anatomical Response vs Visual Recovery in Naïve and Refracto
## Provenance & Clinical Metadata
- **Canonical URL:** https://medichelpline.com/clinical-feed/plos-one-1-use-of-faricimab-for-refractory-diabetic-macular-edema-in-real-world-clinical
- **Specialty:** [General](https://medichelpline.com/clinical-feed/general.md)
- **Primary Source:** PLOS ONE (Medicine)
- **Source URL:** [Original Journal Publication](https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0358993)
- **Published At:** 2026-09-23T14:00:00.000Z
- **Evidence Rating:** Journal Feed
## Executive GIST (TL;DR)
- This retrospective single-center real-world study evaluated 110 eyes (54 naïve, 56 refractory) with diabetic macular edema (**DME**) treated with intravitreal **faricimab** using three monthly loading doses followed by a treat-and-extend regimen over 12 months. - Primary outcomes were changes in best-corrected visual acuity (**BCVA**) and central macular thickness (**CMT**); secondary outcomes were OCT biomarkers including intraretinal cysts (IRCs), subretinal fluid (SRF), hyperreflective foci (HRFs), disorganization of the retinal inner layers (**DRIL**), and external limiting membrane/ellipsoid zone (**ELM/EZ**) disruption. - At 12 months, **CMT** decreased significantly in both naïve and refractory groups (P < 0.001), indicating effective retinal fluid control with faricimab across cohorts. - **BCVA** improved significantly in the naïve group (P = 0.003) but showed only modest, non-significant change in the refractory group (P = 0.390); between-group BCVA differences favored naïve eyes at months 3, 6, and 12. - Both groups had significant reductions in the proportions of eyes with **IRCs**, **SRF**, and **HRFs** (all P < 0.001), demonstrating anatomical resolution of fluid-related OCT biomarkers. - Refractory eyes had longer DME duration and higher baseline prevalence of **DRIL** and **ELM/EZ disruption** (both P < 0.001), microstructural features associated with worse visual prognosis. - In multivariable generalized estimating equation (GEE) modeling, baseline **DRIL** (B = 0.044; 95% CI: 0.004–0.084; P = 0.031) and **ELM/EZ disruption** (B = 0.147; 95% CI: 0.069–0.225; P < 0.001) were independently associated with poorer 12-month **BCVA**; treatment group (naïve vs refractory) was not independently associated (P = 0.969). - The findings indicate that anatomical success (fluid resolution, reduced **CMT**) after faricimab does not always translate into functional recovery when baseline retinal microstructure is compromised; for refractory eyes, sustained fluid control and reduced treatment burden may still be clinically meaningful outcomes. - Safety monitoring and specific adverse event rates were reported as part of the study methods, but detailed safety outcomes were not described in the provided source excerpt.
## Clinical Analysis & Structured Key Points
[ Skip to main content ](https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0358993#main-content) Advertisement * [plos.org](https://plos.org/) * [Create account](https://community.plos.org/registration/new) * [Sign in](https://journals.plos.org/user/secure/login?page=%2Fplosone%2Farticle%3Fid%3D10.1371%2Fjournal.pone.0358993) * * About * Browse * Publish * [](https://journals.plos.org/plosone/ "PLOS One") * Search [advanced search](https://journals.plos.org/plosone/search) * [Browse Topics](https://journals.plos.org/plosone/subjectAreaBrowse) Browse Subject Areas ? Click through the PLOS taxonomy to find articles in your field. For more information about PLOS Subject Areas, click [here](https://github.com/PLOS/plos-thesaurus/blob/master/README.md "Link opens in new window"). [](https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0358993) [](https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0358993) * 0 [Save](https://journals.plos.org/plosone/article/metrics?id=10.1371/journal.pone.0358993#savedHeader) [Total Mendeley and Citeulike bookmarks.](https://journals.plos.org/plosone/article/metrics?id=10.1371/journal.pone.0358993#savedHeader) * 0 [Citation](https://journals.plos.org/plosone/article/metrics?id=10.1371/journal.pone.0358993#citedHeader) [Paper's citation count computed by Dimensions.](https://journals.plos.org/plosone/article/metrics?id=10.1371/journal.pone.0358993#citedHeader) * 0 [View](https://journals.plos.org/plosone/article/metrics?id=10.1371/journal.pone.0358993#viewedHeader) [PLOS views and downloads.](https://journals.plos.org/plosone/article/metrics?id=10.1371/journal.pone.0358993#viewedHeader) * 0 [Share](https://journals.plos.org/plosone/article/metrics?id=10.1371/journal.pone.0358993#discussedHeader) [Sum of Facebook, Twitter, Reddit and Wikipedia activity.](https://journals.plos.org/plosone/article/metrics?id=10.1371/journal.pone.0358993#discussedHeader) Open Access Peer-reviewed Research Article # Use of faricimab for refractory diabetic macular edema in real-world clinical practice: When anatomical success meets functional limits * Zheyao Gu , Roles Data curation, Formal analysis, Investigation, Methodology, Writing – original draft, Writing – review & editing * E-mail: 1181992191@qq.com Affiliation Department of Ophthalmology, The Affiliated Suzhou Hospital of Nanjing Medical University, Suzhou Municipal Hospital, Suzhou, China [ ![ORCID logo](https://journals.plos.org/resource/img/orcid_16x16.png) https://orcid.org/0000-0003-1964-7325 ](https://orcid.org/0000-0003-1964-7325 "ORCID Registry") ⨯ * Ting Xi, Roles Data curation, Investigation, Methodology, Writing – review & editing Affiliation Department of Ophthalmology, The Affiliated Suzhou Hospital of Nanjing Medical University, Suzhou Municipal Hospital, Suzhou, China ⨯ * Xiangying Luo Roles Data curation, Methodology, Resources, Visualization, Writing – review & editing Affiliation Department of Ophthalmology, The Affiliated Suzhou Hospital of Nanjing Medical University, Suzhou Municipal Hospital, Suzhou, China ⨯ # Use of faricimab for refractory diabetic macular edema in real-world clinical practice: When anatomical success meets functional limits * Zheyao Gu, * Ting Xi, * Xiangying Luo ![PLOS](https://journals.plos.org/resource/img/logo-plos-full-color.svg) x * Published: September 23, 2026 * * [Article](https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0358993) * [Authors](https://journals.plos.org/plosone/article/authors?id=10.1371/journal.pone.0358993) * [Metrics](https://journals.plos.org/plosone/article/metrics?id=10.1371/journal.pone.0358993) * [Comments](https://journals.plos.org/plosone/article/comments?id=10.1371/journal.pone.0358993) * [Media Coverage](http://plos.altmetric.com/details/doi/10.1371/journal.pone.0358993) * [Abstract](https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0358993#abstract0) * [1. Introduction](https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0358993#sec005) * [2. Materials and methods](https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0358993#sec006) * [3. Results](https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0358993#sec013) * [4. Discussion](https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0358993#sec022) * [5. Conclusion](https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0358993#sec023) * [References](https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0358993#references) * [Reader Comments](https://journals.plos.org/plosone/article/comments?id=10.1371/journal.pone.0358993) * [Figures](https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0358993) ## Abstract ### Objective To evaluate the anatomical and functional outcomes of faricimab in the treatment of naïve and refractory diabetic macular edema (DME) and to investigate OCT biomarkers associated with visual outcomes. ### Methods This retrospective real-world study included eyes with DME treated with faricimab. All eyes received three loading injections followed by a treat-and-extend regimen. The primary outcomes were changes in best-corrected visual acuity (BCVA) and central macular thickness (CMT). Secondary outcomes included changes in OCT biomarkers, including intraretinal cysts (IRCs), subretinal fluid (SRF), hyperreflective foci (HRFs), disorganization of the retinal inner layers (DRIL), and external limiting membrane/ellipsoid zone (ELM/EZ) disruption. Changes in BCVA, CMT, and OCT biomarkers were analyzed using generalized estimating equations (GEEs). A multivariable GEE model was used to identify factors independently associated with 12-month BCVA. ### Results A total of 110 eyes from 104 patients were included. At 12 months, the CMT significantly decreased in both the naïve and refractory groups (both P 350 μm with a reduction from baseline of ≤15% during this period. This definition was chosen to identify eyes with an inadequate anatomical response despite intensive anti-VEGF therapy and was considered appropriate for evaluating the efficacy of switching to faricimab in a real-world setting. Both groups of patients met the following inclusion criteria: (1) >18 years of age and a diagnosis of type 2 diabetes mellitus; (2) a diagnosis of nonproliferative diabetic retinopathy (NPDR) confirmed by fundus fluorescein angiography (FFA); (3) a CMT on SD-OCT greater than 350 μm, including cystoid, diffuse, or serous retinal detachment patterns; and (4) at least three consecutive loading doses of faricimab. The exclusion criteria were as follows: (1) any history of eye conditions other than diabetic retinopathy (DR); (2) ocular surgery (including cataract surgery and pars plana vitrectomy) or panretinal/focal laser photocoagulation within 12 months prior to enrollment; (3) any intraocular surgery or laser treatment during the study follow-up period; (4) a diagnosis of systemic autoimmune or inflammatory disease; and (5) incomplete medical records or loss to follow-up exceeding 8 weeks. Previous ocular surgeries, including vitrectomy and cataract surgery, or retinal laser treatments performed more than 12 months before enrollment were documented as prior treatment history and did not result in exclusion. ### 2.3 Treatment protocol All eyes received three consecutive monthly loading injections of faricimab, which were administered at baseline, month 1, and month 2, followed by a treat-and-extend regimen from month 3 onward. Treatment intervals were adjusted in 4-week increments according to functional and anatomical assessments. Clinical and OCT evaluations were performed at 4-week intervals throughout follow-up to monitor disease activity. If macular edema recurred, the treatment interval was shortened accordingly to re-establish and maintain macular fluid control. ### 2.4 Data collection and clinical assessments To ensure consistency and precision, two experienced ophthalmologists independently extracted the data. A comprehensive set of clinical variables, including patient demographic data (age and sex), DR severity, baseline intraocular pressure, lens status, and glycosylated hemoglobin (HbA1c) levels, was systematically recorded. Detailed ocular histories, including previous panretinal photocoagulation (PRP) and vitrectomy procedures, were also obtained. We also recorded the drugs, average injection numbers and treatment intervals used for prior anti-VEGF treatment in the refractory group. The average dosing intervals for faricimab and the average number of injections given during the follow-up period were recorded for both groups, in addition to any adverse events related to the intravitreal procedure. Baseline evaluation was conducted on the day of the initial intravitreal injection. Patients then returned for follow-up visits every 4 weeks during the 12-month study period. At each visit, a thorough functional and anatomical examination, which included tonometry, slit lamp biomicroscopy, BCVA measurement, and SD-OCT, was performed, and the patient’s systemic medical history was reviewed. We used an international standard visual acuity chart to measure BCVA. To perform all the statistical calculations, we converted this visual acuity value, which was originally recorded in decimals, into the logarithm of the minimum angle of resolution (logMAR) for all the statistical analyses. Anatomical outcomes were evaluated using spectral-domain OCT (Cirrus 5000, Carl Zeiss Meditec, Dublin, CA). All scans were acquired using the 512 × 128 macular cube acquisition protocol, covering a 6 × 6 mm retinal area centered on the fovea. A 30° circular scan oriented from the nasal to temporal meridian was also obtained, with the foveal depression serving as the anatomical reference point. The CMT was defined as the average retinal thickness within the central 1-mm diameter circular area centered on the fovea. To further characterize retinal microstructura
## Related Clinical Research

- [Global study finds women report more pain than men across 11 body sites](https://medichelpline.com/clinical-feed/medical-news-today-0-women-consistently-experience-more-pain-than-men-across-11-body-parts.md)
- [Higher Ultra-Processed Food Intake Linked to Greater Risk of Multiple Chronic Diseases](https://medichelpline.com/clinical-feed/medical-news-today-0-every-extra-100-grams-of-ultra-processed-foods-tied-to-greater-disease-risk.md)
- [North West London Diabetes Cohort: multiethnic EHR resource for diabetes complications research](https://medichelpline.com/clinical-feed/bmj-open-2-large-scale-multiethnic-electronic-health-record-resource-for-diabetes.md)
- [Sex-specific trajectories to cardio-renal and mental health outcomes after type 2 diabetes onset](https://medichelpline.com/clinical-feed/plos-medicine-1-sex-differences-in-trajectories-to-cardio-renal-and-mental-health-outcomes.md)
- [Muscle-strengthening and Aerobic Activity Linked to Lower Mortality in US Adults with Diabetes](https://medichelpline.com/clinical-feed/pubmed-39913676.md) (DOI: 10.1093/eurjpc/zwaf061)

## Navigation
- [← Back to General Feed](https://medichelpline.com/clinical-feed/general.md)
- [← All Clinical Specialties](https://medichelpline.com/clinical-feed.md)
## Medical & Regulatory Disclaimer

> [!CAUTION]
> MedicHelpline content is structured for research, educational, and professional discovery purposes. It does not constitute individual medical advice, clinical diagnosis, or treatment recommendations.
> Always verify dosing, contraindications, and regulatory alerts against official product labeling and primary regulatory sources before clinical decision-making.