Objective: To evaluate the efficacy and safety of intravitreal faricimab administered under a treat-and-extend (T&E) strategy for DME in a real-world clinical setting, and to analyze factors associated with visual acuity benefits and durability of disease control during interval extension. Methods: This single-center, retrospective cohort study included 170 patients (170 eyes) with diabetic macular edema who initiated intravitreal faricimab treatment between January 2024 and December 2024 and completed at least 12 months of follow-up. Only one eye per patient was included in the analysis. All included eyes completed a three-dose monthly loading phase and were subsequently managed using a faricimab-based treat-and-extend regimen. The primary efficacy endpoints were changes in best-corrected visual acuity (BCVA, ETDRS letters) and central subfield thickness (CST) at 12 months. Key secondary T&E-related endpoints included the total number of injections within 12 months, the maximum treatment interval achieved by month 12, and the proportion of eyes reaching extension intervals of ≥12 and ≥16 weeks. Multivariable linear regression and Cox proportional hazards regression were used to identify exploratory factors associated with visual acuity improvement and time to treatment interval shortening. Results: At 12 months, mean BCVA improved by 9.7 ± 11.5 letters and mean CST decreased by 191.0 ± 135.0 µm (both P < 0.001); 50.0% gained ≥10 letters and 64.7% achieved a dry macula (CST < 300 µm). In multivariable regression, 1-month CST reduction showed the strongest positive association with BCVA gain (B = 0.48 per 100 µm decrease, β = 0.41, P < 0.001), while baseline HbA1c, baseline CST, and ellipsoid zone impairment were negatively associated. Higher baseline HbA1c, CST ≥500 µm, and EZ impairment were associated with interval shortening during the maintenance phase. No serious adverse events occurred. Conclusion: In real-world DME treated with a T&E faricimab regimen, patients achieve sustained functional and anatomical improvements with a favorable safety profile. Twelve-month outcomes and treatment durability were associated with baseline metabolic control, anatomical disease severity, and early CST response, supporting individualized monitoring during treat-and-extend management.
Introduction: Silicone oil, more specifically polydimethylsiloxane (PDMS) of different molecular weight, is an established endotamponade in vitreoretinal surgery. As emulsification is a feared complication of their intraocular use, high-molecular weight compounds (HMWCs) may be added to modify their physicochemical properties lowering emulsification tendency. However, the optical properties of various HMWCs, as well as blends of silicone oils with different fractions of HMWC have never been studied in a controlled laboratory setting and compared with each other. Optical parameters, such as forward light scattering and turbidity, may indicate intermolecular interactions among PDMS fractions with varying molecular weights. Methods: Blends of Siluron 1,000 and different HMWCs in various ratios were created. Viscosities of the pure HMWC components were 60,000 mPas, 100,000 mPas, and 2,500,000 mPas, respectively. Mixtures of Siluron 1,000 with 10%, 30% and 90% HWMC component were created. Light scattering of these blends and the raw components was quantified using a custom-made C-Quant straylight meter and turbidity was quantified with an ISO-normed turbidity meter. Light scattering and turbidity were compared between the different mixtures and the raw materials. Additionally, measurement of Dynamic Light Scattering (DLS) using a Zetasizer was performed to quantify the formation of possible particle-like HMWC aggregates. Results: Turbidity of PDMS showed a molecular weight-associated increase with the highest turbidity values appearing for pure 2,500,000 mPas HMWC-PDMS. For mixtures of Siluron 1,000 with 100,000 mPas and 2,500,000 mPas HMWC-PDMS, an increased turbidity was observed when the HMWC component exceeded 10%. Forward light scattering values were very low for all tested samples, slightly increased values were only detectable for mixtures with a proportion of 90% HMWC components. DLS revealed a concentration- and molecular weight dependent appearance of particle-like phenomena. Conclusion: Although there was no evidence of clinically relevant optical disturbances for all tested substances, the molecular-weight dependent optical properties of HMWC-blends may be attributed to the presence of optically active particles when mixtures exceed a 10% proportion of high-molecular weight components, specifically for 100,000 and 2,500,000 mPas HWMC PDMS. This finding may indicate suboptimal solubility and compromised intermolecular interaction.
Since the publication in 2014 of the original EURETINA guidelines for the management of neovascular age-related macular degeneration (nAMD), the treatment landscape for this prevalent and potentially devastating condition has evolved substantially. Along with the introduction of new anti-vascular endothelial growth factor (anti-VEGF) agents and the release of biosimilar agents, anti-VEGF dosing strategies have been refined, and increasing amounts of clinical trial and real-world evidence are available to inform practice. To provide an updated European perspective on nAMD management, the EURETINA panel systematically reviewed European guidelines published since 2014 alongside recent randomized controlled trials and other relevant evidence. Areas of broad consensus across guidelines were identified, including the importance of early diagnosis and prompt initiation of anti-VEGF therapy, and the central role of optical coherence tomography (OCT) in both diagnosis and monitoring. Treat-and-extend regimens are now established as the preferred approach for retreatment, with disease activity defined primarily by changes in retinal fluid accumulation detected by OCT imaging. Recommendations also address follow-up, switching or discontinuing therapy, and referral to low vision support services. Incorporating the EURETINA panel’s expertise into this synthesis, this update to the EURETINA guidelines for nAMD provides recommendations to guide high-quality, evidence-based care for patients with nAMD across Europe.
Introduction: This study aimed to determine the prevalence and clinical phenotype of subretinal fluid (SRF) in eyes with diabetic macular edema (DME). Methods: A retrospective study was conducted in treatment-naive patients with DME. The presence of SRF, hard exudates, and cystoid spaces with hyperreflective material on optical coherence tomography B-scans, along with central macular thickness (CMT) in the 1-mm, 3-mm, and 6-mm central areas, was assessed, and the correlation between the presence of SRF and macular thickness was estimated using linear mixed-effects models. Results: Of 101 eyes from 63 patients (49% men, mean age 61.31 ± 9.45 years), 36% had SRF. SRF was significantly and independently associated with macular thickness, with higher 1-mm, 3-mm and 6-mm CMT compared to eyes without SRF (β = 104.7 [95% CI, 53.5; 156] µm, p < 0.001; β = 80.5 [95% CI, 45.9; 115.2] µm, p < 0.001; β = 55.1 [95% CI, 30.1; 80] µm, p < 0.001, respectively). Even though macular thickness was significantly associated with visual acuity, SRF was not associated (β = 0.127 [95% CI, −0.034; 0.287]; p = 0.12). However, in eyes with SRF, width (but not height) of the SRF was independently associated with lower visual acuity (β = 0.00017; [95% CI: 0.00003–0.00031]; p = 0.028). Conclusion: DME patients with SRF exhibited higher macular thickness compared to those without SRF, suggesting SRF is an anatomical marker of a more severe exudative process. However, SRF’s independent impact on visual acuity was limited and modest in magnitude, suggesting further studies could improve our understanding of the pathophysiological and clinical significance of SRF in DME.
Introduction: Diabetic macular edema (DME) is a significant cause of vision loss in patients with diabetic retinopathy, and treatment outcomes in routine clinical practice may differ from those reported in randomized clinical trials. We assessed the real-world effectiveness and treatment patterns of intravitreal bevacizumab, aflibercept (2 mg), and ranibizumab in patients newly diagnosed with DME. Methods: A retrospective, multicenter observational study with a 1-year follow-up was conducted at public clinics in Israel and Canada. A total of 309 eyes from 277 treatment-naive patients with DME were analyzed, including both eyes from 32 patients. Eyes were grouped by the first-line therapy: bevacizumab (n = 199), aflibercept 2 mg (n = 63), or ranibizumab (n = 47). The primary endpoint was change in visual acuity (VA) at 1 year. Secondary endpoints included change in central retinal thickness (CRT), injection frequency, final injection interval, and treatment response metrics. Generalized estimating equation (GEE) models were used to account for inter-eye correlation. Results: At 12 months, VA improved by 6 ETDRS letters with no significant difference between groups in the primary endpoint (p = 0.501). In adjusted GEE analyses using bevacizumab as the reference group, aflibercept and ranibizumab were associated with greater CRT reduction (−60.31 µm and −57.24 µm, respectively), longer final injection intervals (+3.52 and +2.58 weeks), and fewer injections over 12 months (−2.05 and −2.21; all p < 0.001). Aflibercept was also associated with lower odds of nonresponse (OR 0.08, p = 0.010), and both aflibercept and ranibizumab were associated with lower odds of non-extension (OR 0.08 and OR 0.02, respectively; both p < 0.001). Conclusion: In this real-world multicenter cohort, VA improved after anti-VEGF treatment, without a significant between-group difference in the primary visual endpoint. Aflibercept (2 mg) was associated with more favorable secondary anatomical and treatment-burden metrics in adjusted analyses. However, given center-determined treatment allocation and residual baseline CRT imbalance, these findings should be interpreted as exploratory real-world associations rather than definitive evidence of pharmacological superiority. These results highlight the gap between randomized trial efficacy and outcomes observed in routine clinical practice, supporting the need for further practice-based DME research.
