Michael Hafner

Mr. Michael Hafner

orcid

Research Focus & Metrics

Academic Career Length

2Years (2025-Present)

(Calculated once Scilit publication data is synced: current year − year of first publication + 1)

Representative Publications

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Verified
Journal Article
Open access
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MHMichael Hafner
Michael Hafner
THTina R Herold
Tina R Herold
AKAlexander Kufner
Alexander Kufner
BABen Asani
Ben Asani
AAAndreas Anschütz
Andreas Anschütz
JSJohannes Schiefelbein
Johannes Schiefelbein
Background/Objectives: Macular edema (ME), due to retinal vein occlusion (RVO), is a major cause of vision impairment. Many patients experience suboptimal responses to anti-vascular endothelial growth factor (anti-VEGF) monotherapy, necessitating alternative treatment approaches. Faricimab, a bispecific antibody targeting VEGF-A and angiopoietin-2 (Ang-2), introduces a novel dual-mechanism therapy. This study evaluates the short-term real-world efficacy of switching to Faricimab in patients with treatment-resistant ME secondary to RVO. Methods: This retrospective study included patients from LMU University Hospital who were switched to Faricimab due to an inadequate response or adverse events related to prior intravitreal therapy (Ranibizumab, Aflibercept, or OzurdexTM). All patients completed a structured loading phase of four monthly injections. Key outcome measures included changes in best-corrected visual acuity (BCVA, logMAR), central subfield thickness (CST, µm), and intraretinal fluid (IRF) presence on optical coherence tomography (OCT). Changes were assessed from baseline (mo0) to three months (mo3). Results: The study included 19 eyes from 19 patients (mean age 63.0 ± 14.2 years). BCVA improved from 0.20 logMAR at baseline to 0.00 logMAR at mo3 (p < 0.01). CST decreased from 325 µm to 280 µm (p < 0.01). The proportion of eyes with IRF reduced from 100% to 32% (p < 0.01). Significant reductions in retinal volume within the 1 mm and 6 mm (both p < 0.01) circles of the ETDRS grid were observed. Conclusions: Switching to Faricimab in patients resulted in significant short-term improvements in BCVA, CST, and IRF resolution. Given the small sample size and retrospective design, these findings should be interpreted as exploratory and hypothesis-generating. Further studies are needed to evaluate long-term efficacy and optimal treatment regimens.

11 April 2025 in International Journal of Retina and Vitreous
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Journal Article
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MHMichael Hafner
Michael Hafner
FEFranziska Eckardt
Franziska Eckardt
JSJakob Siedlecki
Jakob Siedlecki
BSBenedikt Schworm
Benedikt Schworm
THTina R. Herold
Tina R. Herold
JSJohannes B. Schiefelbein
Johannes B. Schiefelbein
Background: Artificial intelligence (AI)-driven biomarker segmentation offers an objective and reproducible approach for quantifying key anatomical features in neovascular age-related macular degeneration (nAMD) using optical coherence tomography (OCT). Currently, Faricimab, a novel bispecific inhibitor of vascular endothelial growth factor (VEGF) and angiopoietin-2 (Ang-2), offers new potential in the management of nAMD, particularly in treatment-resistant cases. This study utilizes an advanced deep learning-based segmentation algorithm to analyze OCT biomarkers and evaluate the efficacy and durability of Faricimab over nine months in patients with therapy-refractory nAMD. Methods: This retrospective real-world study analyzed patients with treatment-resistant nAMD who switched to Faricimab following inadequate responses to ranibizumab or aflibercept. Automated segmentation of key OCT biomarkers - including fibrovascular pigment epithelium detachment (fvPED), intraretinal fluid (IRF), subretinal fluid (SRF), subretinal hyperreflective material (SHRM), choroidal volume, and central retinal thickness (CRT) - was conducted using a deep learning algorithm based on a convolutional neural network. Results: A total of 46 eyes from 41 patients completed the nine-month follow-up. Significant reductions in SRF, fvPED, and choroidal volume were observed from baseline (mo0) to three months (mo3) and sustained at nine months (mo9). CRT decreased significantly from 342.7 (interquartile range (iqr): 117.1) µm at mo0 to 296.6 (iqr: 84.3) µm at mo3 and 310.2 (iqr: 93.6) µm at mo9. The deep learning model provided precise quantification of biomarkers, enabling reliable tracking of disease progression. The median injection interval extended from 35 (iqr: 15) days at mo0 to 56 (iqr: 20) days at mo9, representing a 60% increase. Visual acuity remained stable throughout the study. Correlation analysis revealed that higher baseline CRT and fvPED volumes were associated with greater best-corrected visual acuity (BCVA) improvements and longer treatment intervals. Conclusions: This study highlights the potential of AI-driven biomarker segmentation as a precise and scalable tool for monitoring disease progression in treatment-resistant nAMD. By enabling objective and reproducible analysis of OCT biomarkers, deep learning algorithms provide critical insights into treatment response. Faricimab demonstrated significant and sustained anatomical improvements, allowing for extended treatment intervals while maintaining disease stability. Future research should focus on refining AI models to improve predictive accuracy and assessing long-term outcomes to further optimize disease management. Trial registration: Ethics approval was obtained from the Institutional Review Board of LMU Munich (study ID: 20–0382). This study was conducted in accordance with the Declaration of Helsinki.

25 March 2025 in Ophthalmology and Therapy
Verified
Journal Article
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MHMichael Hafner
Michael Hafner
BABen Asani
Ben Asani
FEFranziska Eckardt
Franziska Eckardt
JSJakob Siedlecki
Jakob Siedlecki
BSBenedikt Schworm
Benedikt Schworm
JSJohannes Schiefelbein
Johannes Schiefelbein
Introduction Artificial intelligence (AI)-driven biomarker segmentation offers an objective approach to assessing neovascular age-related macular degeneration (nAMD). In addition, faricimab, a bispecific VEGF and Ang-2 inhibitor, presents new potential in disease management. This study applies an AI-based segmentation algorithm to quantify key optical coherence tomography (OCT) biomarkers and assess the short-term efficacy of intravitreal faricimab in treatment-naïve patients. Methods This retrospective analysis includes 40 eyes from 38 treatment-naïve patients with nAMD treated with faricimab at LMU University Hospital Munich between January 2023 and September 2024. Patients received 4-monthly intravitreal injections. Biomarkers of disease activity, including central retinal thickness (CRT), intraretinal fluid (IRF), subretinal fluid (SRF), subretinal hyperreflective material (SHRM) and fibrovascular pigment epithelium detachment (fvPED), were quantified using a deep learning-based semantic segmentation algorithm. Best-corrected visual acuity (BCVA) and OCT imaging data were analyzed at baseline (mo0) and after 1 (mo1), 2 (mo2) and 3 months (mo3). Results AI-driven analysis revealed significant reductions in key biomarkers. CRT decreased from 433.6 (IQR: 306.6) µm at mo0 to 241.5 (IQR: 130.8) µm at mo3 (p < 0.0001). IRF and SRF volumes were reduced by > 99% from mo0 to mo3 (both p < 0.0001). BCVA improved from 0.60 (IQR: 0.30) logMAR at mo0 to 0.40 (IQR: 0.33) logMAR at mo3 (p < 0.0001). Correlation analysis identified IRF and SHRM reductions as the strongest predictors of visual improvement. Conclusion This study demonstrates the potential of AI-assisted biomarker analysis for precise disease monitoring in nAMD. Faricimab significantly reduced disease activity biomarkers and improved visual acuity in treatment-naïve patients, reinforcing its efficacy in early disease control. Future studies should explore long-term outcomes and further integrate AI-driven biomarker evaluation in clinical practice.

1 May 2025 in BMJ Open Ophthalmology
Verified
Journal Article
Open access
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MHMichael Hafner
Michael Hafner
BABen Asani
Ben Asani
FEFranziska Eckardt
Franziska Eckardt
CLCaspar Liesenhoff
Caspar Liesenhoff
AKAlexander Kufner
Alexander Kufner
JSJohannes Schiefelbein
Johannes Schiefelbein
Purpose: Age-related macular degeneration (AMD) remains the leading cause of blindness in developed countries. There are many different intravitreal anti-vascular endothelial growth factor (VEGF) drugs available for the treatment of neovascular AMD (nAMD). Unfortunately, not all patients respond equally well to the drugs, and some show recurrences during treatment. Since 01/2024, aflibercept 8 mg represents an additional treatment option and contains a four times higher dosage than the already known aflibercept 2 mg. Methods: To evaluate the real-world efficacy of aflibercept 8 mg in refractory nAMD patients, focusing on changes in key optical coherence tomography biomarkers over a follow-up period of the first four aflibercept 8 mg injections using a deep learning-based semantic segmentation algorithm. Inclusion criteria were: switch to aflibercept 8 mg after insufficient response to aflibercept 2 mg, marked by persistent retinal fluid or inability to extend treatment beyond 6 weeks; completion of at least 3 months (90 days) follow-up under treat-and-extend treatment regime; and no confounding conditions like intraocular infection, uveitis or other retinal diseases. Results: 23 eyes of 21 patients with therapy-resistant nAMD were switched to aflibercept 8 mg. All patients had previously received aflibercept 2 mg, with an average of 30.7 previous anti-VEGF injections. Significant reductions in intraretinal fluid and fibrovascular pigment epithelial detachment at timepoint V3 were observed. The decrease in subretinal fluid and central retinal thickness at V3 was not significant. Treatment intervals extended significantly by 24%, from a baseline average of 34 days to 42 days. Best-corrected visual acuity remained stable throughout the study period. Conclusions: Aflibercept 8 mg demonstrated significant efficacy and durability in reducing nAMD biomarkers and extending intervals in a real-world setting. The use of deep learning for biomarker quantification highlighted its potential for enhancing treatment monitoring and decision-making. Future studies with a larger patient cohort and prospective study setting should explore long-term outcomes and integration of artificial intelligence-driven analysis.

20 June 2025 in Scientific Reports
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Journal Article
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MHMichael Hafner
Michael Hafner
SPSiegfried G. Priglinger
Siegfried G. Priglinger
BLBettina von Livonius
Bettina von Livonius
MGMaximilian J. Gerhardt
Maximilian J. Gerhardt
Optical Coherence Tomography Angiography (OCTA) has become an essential non-invasive imaging technique for high-resolution visualization of retinal microvasculature. This study evaluates the performance of a novel Swept-Source OCTA device, Intalight DREAM, compared to established systems: Heidelberg Spectralis, Topcon Triton, and Zeiss Cirrus. We assessed acquisition time and microvascular parameters in the superficial (SCP) and deep (DCP) capillary plexuses using the OCTA Vascular Analyser algorithm for standardized image analysis across devices on 30 eyes from 15 healthy participants. In the SCP, DREAM demonstrated a higher median vessel length (47 μm) and greater fractal dimension (mean: 1.999) than the other devices, indicating enhanced continuity and network complexity. In the DCP, DREAM showed a smaller foveal avascular zone (median: 0.339 mm2) compared to Spectralis (0.51 mm2), Triton (0.5935 mm2), and Cirrus (0.9145 mm2), along with a smaller vessel diameter (median: 23 μm) compared to Triton and Cirrus. With a median imaging time of 9.1 s, DREAM was significantly faster than the Spectralis system (23.3 s) while providing largely comparable image quality, enhancing patient comfort, and potentially minimizing motion artifacts. These findings suggest that DREAM OCT is a promising tool for deep retinal imaging, with strong potential for clinical application and research.

13 October 2025 in Journal of Clinical Medicine
Verified
Journal Article
Open access
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MHMichael Hafner
Michael Hafner
THTina R Herold
Tina R Herold
AKAlexander Kufner
Alexander Kufner
FEFranziska Eckardt
Franziska Eckardt
BABen Asani
Ben Asani
JSJohannes Schiefelbein
Johannes Schiefelbein
Background: Macular edema (ME) secondary to retinal vein occlusion (RVO) is a significant cause of vision impairment. Many patients show suboptimal responses to anti-vascular endothelial growth factor (anti-VEGF) monotherapy, prompting the exploration of alternative treatments. Faricimab is a bispecific antibody that targets VEGF-A and angiopoietin-2. We report 9-month real-world outcomes of switching to faricimab in therapy-resistant RVO-associated ME. Methods: In this retrospective study at a single tertiary center, patients with persistent or recurrent ME despite prior treatments (ranibizumab, aflibercept, or dexamethasone implant) were switched to faricimab. All eyes received a loading phase of four monthly faricimab injections, followed by a treat-and-extend regimen individualized per response. Key outcomes included best-corrected visual acuity (BCVA, logMAR), the central subfield thickness (CST, μm), and the intraretinal fluid (IRF) status on optical coherence tomography, assessed from the baseline (month 0, mo0) through the loading phase (mo1–mo3) and at month 9 (mo9). Results: Nineteen eyes (19 patients, mean age 64.8 years) were analyzed. The median BCVA improved from 0.20 to 0.00 logMAR by month 3 (p < 0.01) and was maintained at month 9. The median CST decreased from 325 μm at the baseline to 285 μm at month 3 (p < 0.01) and remained at 285 μm at month 9. IRF was present in 100% of eyes at the baseline, 26% at month 3, and 26% at month 9 (p < 0.01 for the baseline vs. month 9). Among eyes previously on anti-VEGF therapy (n = 14), the median treatment interval increased from 45.50 days at the baseline to 56.50 days at month 9 (p = 0.01; δ = 0.86). No intraocular inflammation or other adverse events were observed in this cohort over nine months. Conclusions: In this retrospective series, switching to faricimab was associated with improvements in vision and retinal anatomy that were maintained over 9 months; injection intervals were extended in a subset of eyes. These exploratory findings warrant confirmation in larger, controlled studies to define long-term effectiveness, safety, and dosing strategies.