To quantify early real-world visual acuity (VA) responder rates at 25–35 days after idiopathic full-thickness macular hole (FTMH) surgery and evaluate the influence of hole size, gas tamponade, and prescribed duration of face-down positioning. In this retrospective cohort study, 193 eyes were analyzed after pars plana vitrectomy with internal limiting membrane peeling and SF6 20
To characterise morphological changes in neovascular age-related macular degeneration (nAMD) during anti-angiogenic therapy and explore relationships with best-corrected visual acuity (BCVA) and development of macular atrophy (MA). Post-hoc analysis of the phase III HARBOR trial. SD-OCT scans from 1097 treatment-naïve nAMD eyes were analysed. Volumes of intraretinal cystoid fluid (ICF), subretinal hyperreflective material (SHRM), subretinal fluid (SRF), pigment epithelial detachment (PED) and cyst-free retinal volume (CFRV) were measured by deep-learning model. Volumes were analysed by treatment regimen, macular neovascularisation (MNV) subtypes and topographic location. Associations of volumetric features with BCVA and MA development were quantified at month 12/24. Differences in feature volume changes by treatment regimens and MNV subtypes were observed. Each additional 100 nanolitre unit (AHNU) of residual ICF, SHRM and CFRV at month 1 in the fovea was associated with deficits of 10.3, 7.3 and 12.2 letters at month 12. Baseline AHNUs of ICF, CFRV and PED were associated with increased odds of MA development at month 12 by 10
This study evaluates the efficacy and safety of faricimab in a real-world cohort of treatment-naïve patients with neovascular age-related macular degeneration (nAMD). Data were retrospectively collected from 130 eyes of 118 patients across 11 centers of the Swiss Retina Research Network, all treated with faricimab using a treat-and-extend regimen and followed for 12 months between May 2022 and October 2024. Demographic data, visual and anatomical outcomes, treatment intervals, and adverse events were extracted from the electronic medical records over a 12-month follow-up period. Main outcomes included change in best corrected visual acuity (BCVA), central retinal thickness (CRT), presence of intra- and subretinal fluid, retinal pigment epithelial detachment (PED), injection intervals, and safety. Data are presented as mean ± standard deviation. Twelve months after the initiation of faricimab therapy, mean BCVA improved from 64.6 ± 14.1 to 69.2 ± 20.3 ETDRS (Early Treatment of Diabetic Retinopathy Study) letters (p < 0.001), while mean CRT decreased from 386.3 ± 172.3 to 246.6 ± 90.4 μm (p < 0.001). An early anatomical response to faricimab was observed in 34.6
Purpose:To evaluate the effectiveness and safety of intravitreal aflibercept 8 mg (Afl 8) for the therapy of treatment-naïve and pretreated diabetic macular edema (DME) in a clinical routine setting. Design:A multicenter, retrospective cohort study of consecutive DME patients treated with Afl 8 over 12 months. Subjects:One hundred fifty-six eyes (124 patients) with DME, including 42 (26.9%) treatment-naïve and 114 (73.1%) pretreated eyes receiving Afl 8 for 1 year. Methods:Data from electronic medical records were collected retrospectively at 5 predefined time points. The primary outcomes were the mean changes in corrected visual acuity (VA), center-point retinal thickness (CRT), central subfield thickness (CST), treatment intervals, and adverse events (AEs). Secondary outcomes included the number of injections, persistent fluid, and treatment adherence. These parameters were recorded from the beginning of anti-VEGF treatment until switching occurred in pretreated eyes. Main Outcome Measures:Mean change in VA, CRT, CST, treatment intervals, and AEs. Results:In treatment-naïve eyes, VA improved from 72.9 ± 10.7 ETDRS letters at baseline to 77.7 ± 9.7 (P = 0.006); and from 73.9 ± 11.2 to 75.4 ± 10.1 ETDRS letters (P = 0.094) in pretreated eyes. Central subfield thickness decreased in both groups (naïve: 448.9 ± 154.3 μm to 320.0 ± 80.1 μm, P < 0.001; pretreated: 336.6 ± 90.5 μm to 310.2 ± 69.9 μm, P = 0.047). After 12 months, 38.1% of naïve eyes and 27.2% of pretreated eyes were free of retinal fluid in the central 1 mm. In treatment-naïve eyes, the mean treatment interval was 15.3 ± 12.0 weeks at 12 months. In pretreated eyes, the interval increased from 7.6 ± 3.7 weeks at the time of switching to 13.0 ± 9.0 weeks (P < 0.001). Two eyes (4.8%) in the naïve group and 16 eyes (14%) in the switcher group were switched away within the first year due to insufficient response to Afl 8 therapy. No AEs were reported in the treatment-naïve group. In the pretreated group, 3 cases of noninfectious intraocular inflammation (IOI; 1.9%; 1 recurrent), 2 instances of acute intraocular pressure rise, and 1 vitreous hemorrhage were reported. Conclusions:Afl 8 offers a promising approach to reducing the treatment burden in DME. It enables extended dosing intervals without compromising efficacy and safety, especially in refractory eyes. However, a possibly increased rate of mild IOI has been observed. Financial Disclosures:Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
This study reports the 1-year efficacy of aflibercept 8 mg (afl8) in a real-world cohort of treatment-naïve patients with neovascular age-related macular degeneration (nAMD). An observational, retrospective case series from nine centers of the Swiss Retina Research Network including treatment-naïve eyes with nAMD started on intravitreal afl8. Changes in visual acuity (VA), macular thickness, pigment epithelial detachment (PED) height, and retinal fluids were evaluated over 12 months and compared with baseline. Treatment intervals and safety data were recorded along with subgroup analyses based on macular neovascularization type, loading-phase completion, and treatment regimen. A total of 91 eyes met the inclusion criteria. After 1 year of treatment, VA changed by + 1.0 ± 13.2 letters (p = 0.018), mean CST changed by −110.0 ± 130.9 µm (p < 0.001), and mean PED height changed by −71.2 ± 104.8 µm (p < 0.001). After 12 months, 66.2
Intravitreal anti-vascular endothelial growth factor (anti-VEGF) therapy has revolutionised the treatment of neovascular age-related macular degeneration (nAMD), significantly improving visual outcomes and enhancing the quality of life for affected patients. However, the decision to discontinue anti-VEGF therapy in nAMD management remains complex and lacks consensus, with various criteria being applied. This narrative review examines the available evidence on the cessation of anti-VEGF treatment in nAMD in detail.
PURPOSE:To report the efficacy and safety of switching to faricimab in a real-world, Swiss cohort of patients with pretreated neovascular age-related macular degeneration (nAMD). DESIGN:Retrospective, multicenter, longitudinal observational study conducted at 11 centers of the Swiss Retina Research Network. SUBJECTS:We included 353 eyes of 325 patients who were switched to intravitreal faricimab after prior anti-VEGF therapy and followed for a minimum of 12 months between May 1, 2022, and October 30, 2024. METHODS:Demographic characteristics, baseline functional and OCT findings, treatment history, and outcomes at 12 months after switch to faricimab were extracted from the patients' electronic case report forms. MAIN OUTCOME MEASURES:Change in best-corrected visual acuity (BCVA), central subfield thickness (CST), presence of retinal fluid (RF) and pigment epithelial detachment, treatment intervals, and safety signals. RESULTS:Twelve months after switch, mean BCVA remained unchanged, whereas mean CST decreased from 315.3 to 263.9 μm (P < 0.01). Fast drying (absence of RF) after 1 faricimab injection was observed in 134 eyes (38%) and correlated positively with the treatment interval at 12 months (r(301) = 0.24; P < 0.01). After 12 months, 169 (47.9%) eyes demonstrated the absence of RF compared with 10.2% at switch. Mean treatment interval increased from 5.8 ± 2.5 weeks at switch to 8.3 ± 4.2 weeks at 12 months, and extended treatment intervals (≥12 week) were achieved in 20% of patients. Mild intraocular inflammation was reported in 1.7% of cases. CONCLUSIONS:Switching to faricimab in pretreated nAMD led to sustained anatomic improvements and stabilization of BCVA, with a substantial reduction in RF compared with baseline. Our results suggest the potential benefits of this switching strategy based on real-world data. FINANCIAL DISCLOSURE(S):Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
Aims/Purpose: To characterize the hyperreflective material (HRM) change over 9‐month follow‐up in treatment‐naïve neovascular age‐related macular degeneration (nAMD) eyes who underwent antiangiogenic treatment. Methods: Spectral‐domain optical coherence tomography images of 207 study eyes enrolled in AVENUE trial were included to analyse HRM features including location, evolvement and boundaries. We looked for the development of a highly hyperreflective band with continuity to the adjacent unaffected retinal pigment epithelium on the inner aspect of persistent HRM, which we termed complete HRM‐BR, if more than 90% of HRM was covered by this feature. Other HRM evolution patterns included complete resolution of subretinal HRM (SHRM) and partial/no remodelling of persistent SHRM. We analysed associations of HRM morphological patterns with vision and intralesional hypertransmission into the choroid (HTC), a proxy for HRM‐associated macular atrophy, at Month 9. Predictive features for complete HRM‐BR were explored. Results: At Month 9, persistent SHRM was present in 57% of the 207 included eyes. Of these, complete HRM‐BR developed in 44.9%, which was associated with greater visual outcome (+4.2 letters vs. −6.1 letter) and less intralesional HTC (20.8% vs. 69.2%) compared to partial/no HRM‐BR at Month 9. These eyes with complete HRM‐BR had similar visual outcome and intralesional HTC development to eyes with resolved SHRM (+2.2 letters; 26.8%). Presence of intralesional HTC (baseline OR 0.06, month 1 OR 0.18, p ≤ 0.01) was associated with lower odds of complete HRM‐BR development by month 9. Conclusions: In nAMD eyes undergoing antiangiogenic therapy, complete HRM‐BR developed frequently when SHRM persisted. It was associated with better visual outcome and less MA compared to eyes with partial/no HRM‐BR, and with similar outcomes compared to those with resolved SHRM. This morphological pattern can be predicted at an early stage by RPE‐related HRM features.
Introduction: During the COVID-19 pandemic, reducing aerosol-generating procedures became fundamental, particularly in ophthalmic surgeries traditionally performed under general anesthesia (GA). Regional anesthesia, such as sub-Tenon’s block (STB), is widely used in vitreoretinal surgeries, offering a safer alternative by avoiding airway manipulation. However, the altered orbital anatomy in patients with previous scleral explant surgery creates unique challenges to STB application. This study aims to evaluate the effectiveness, safety, and feasibility of STB in patients after encircling band surgery. Methods: This retrospective analysis included 46 patients with a history of scleral explant surgery, undergoing vitreoretinal procedures at the Bern University Hospital. All procedures were conducted under STB with either analgosedation or GA for additional support when required. An ophthalmic surgeon or an experienced anesthesiologist performed the STBs. Data collected included block success rate, procedural difficulty, incidence of chemosis, and patient satisfaction. The Institutional Ethics Committee approved this study, and all participants provided informed consent. Results: STB was successfully administered in 93.5% of cases, with only three unsuccessful blocks. Block placement was rated as easy in 55% of cases, moderately difficult in 28%, and difficult in 17%. Chemosis was observed in 24% of patients, with severe cases in only 4%. Patient satisfaction scores were high, with most patients expressing satisfaction with the STB procedure. Conversion to GA was required in only one case due to alcohol withdrawal-related agitation. Discussion: The high success rate and minimal complications suggest that STB is a feasible and safe alternative to GA in patients with prior scleral buckling surgery. The altered orbital anatomy presents potential challenges, including scar tissue and compartmentalization, which may lead to patchy anesthesia. However, the use of STB avoids the risks associated with GA and may be especially beneficial for elderly or frail patients. Future studies should further investigate the hemodynamic implications of STB in these cases and the potential for ultrasound-guided techniques to improve accuracy and safety.
The authors regret that the cited reference on page 843 in the sentence "The recently published review of fibrosis (…)" should be "16" (not "61", as cited). The authors would like to apologize for any inconvenience caused. Fibrosis in neovascular age-related macular degeneration: A review of definitions based on clinical imagingSurvey of OphthalmologyVol. 68Issue 5PreviewDespite the success of antiangiogenic therapy in controlling exudation in neovascular age-related macular degeneration (nAMD), the involvement of the outer retina in fibrosis results in gradual vision loss over time. The development of drugs that prevent or ameliorate fibrosis in nAMD requires that it is accurately detected and quantified with reliable endpoints and identification of robust biomarkers. Achievement of such an aim is currently challenging due to the lack of a consensus definition of fibrosis in nAMD. Full-Text PDF Open Access
Objective: To describe the spatial and temporal characteristics of hyperreflective material (HRM) on spectral-domain OCT (SD-OCT) in neovascular age-related macular degeneration (nAMD) during antiangiogenic treatment and explore associations with best-corrected visual acuity (BCVA) and macular atrophy (MA). Design: Retrospective regrading of SD-OCT-images from the multicenter, randomized controlled AVENUE trial (NCT02484690, conducted from August 2015 to September 2017). Participants: Treatment-naive nAMD patients enrolled from 50 sites in the US. Methods: Retrospective regrading and secondary analysis. Main Outcome Measures: Spectral-domain OCT images from 207 study eyes that fit criteria for the present analysis were graded for HRM features, its evolution, and associated hypertransmission into choroid (HTC), a proxy for MA. The appearance of a well-defined hyperreflective inner boundary that separated persistent HRM from the neurosensory retina continuous with the adjacent retinal pigment epithelium layer was defined as hyperreflective material boundary remodeling (HRM-BR). Patterns of HRM composition/evolution were defined as follows: (1) no subretinal HRM at baseline, (2) fully resolved, (3) persistent with complete HRM-BR, or (4) partial/absent HRM-BR. Associations of HRM patterns with BCVA and HTC were analyzed. Predictive factors for complete HRM-BR were explored. Results: Of 207 included eyes, subretinal HRM was present in 159 (76.8%) at baseline and persisted until month 9 in 118 (57.0%) eyes. Of these 118 eyes, 44.9% developed complete HRM-BR and had similar BCVA outcomes by month 9 compared with no/fully resolved subretinal HRM. Partial/absent HRM-BR had a strong negative association with BCVA outcome (-6.1 ETDRS letters; P = 0.016) and a higher frequency of intralesional HTC (69.2%) compared with eyes with complete HRM-BR (20.8%) at month 9. Older age (odds ratio [OR], 0.96; P = 0.054) and presence of intralesional HTC (OR, 0.06; P = 0.010) at baseline were associated with lower odds of complete HRM-BR at month 9. Conclusions: In nAMD eyes under antiangiogenic treatment, complete HRM-BR occurred frequently and was associated with better BCVA than when HRM-BR was only partial/absent.
Despite the success of antiangiogenic therapy in controlling exudation in neovascular age-related macular degeneration (nAMD), the involvement of the outer retina in fibrosis results in gradual vision loss over time. The development of drugs that prevent or ameliorate fibrosis in nAMD requires that it is accurately detected and quantified with reliable endpoints and identification of robust biomarkers. Achievement of such an aim is currently challenging due to the lack of a consensus definition of fibrosis in nAMD. As a first step towards the establishment of a clear definition of fibrosis, we provide an extensive overview of the imaging modalities and criteria used to characterize fibrosis in nAMD. We observed variety in the selection of individual and combinations of imaging modalities, and criteria for detection. We also observed heterogeneity in classification systems and severity scales for fibrosis. The most commonly used imaging modalities were color fundus photography, fluorescein angiography and optical coherence tomography (OCT). A multimodal approach was frequently utilized. Our review suggests that OCT offers a more detailed, objective and sensitive characterization than color fundus photography/fluorescein angiography. Thus, we recommend it as a primary modality for fibrosis evaluation. This review provides a basis for future discussions to reach a consensus definition using standardized terms based on a detailed characterization of fibrosis, its presence and evolution, and taking into consideration impact on visual function. Achieving this goal is of paramount importance for the development of antifibrotic therapies.
Abstract Background Currently used screening criteria for retinopathy of prematurity (ROP) show high sensitivity for predicting treatment-requiring ROP but low specificity; over 90% of examined infants do not develop ROP that requires treatment (type 1 ROP). A novel weight gain-based prediction model was developed by the G-ROP study group to increase the specificity of the screening criteria and keep the number of ophthalmic examinations as low as possible. This retrospective cohort study aimed to externally validate the G-ROP screening criteria in a Swiss cohort. Methods Data from 645 preterm infants in ROP screening at Inselspital Bern between January 2015 and December 2019 were retrospectively retrieved from the screening log and analysed. The G-ROP screening criteria, consisting of 6 trigger parameters, were applied in infants with complete data. To determine the performance of the G-ROP prediction model for treatment-requiring ROP, sensitivity and specificity were calculated. Results Complete data were available for 322 infants who were included in the analysis. None of the excluded infants had developed type 1 ROP. By applying the 6 criteria in the G-ROP model, 214 infants were flagged to undergo screening: among these, 14 developed type 1 ROP, 9 developed type 2 ROP, and 43 developed milder stages of ROP. The sensitivity for predicting treatment-requiring ROP was 100% (CI, 0.79–1.00), and the specificity was 41% (CI, 0.35 –0.47). Implementing the novel G-ROP screening criteria would reduce the number of infants entering ROP screening by approximately one third. Conclusions The overall prevalence of treatment-requiring ROP was low (2.15%). Previously published performance parameters for the G-ROP algorithm were reproducible in this Swiss cohort. Importantly, all treatment-requiring infants were correctly identified. By using these novel criteria, the burden of screening examinations could be significantly reduced.
More than 15 years ago, the results of the pivotal trials supporting the intravitreal use of ranibizumab were published [...].
Optical microsurgery of the retinal pigment epithelium (RPE) requires reliable real-time dosimetry to prevent unwanted overexposure of the neuroretina. The system used in this experiment implements optical coherence tomography (OCT) to detect the intentional elimination of RPE cells. We evaluated the performance of OCT dosimetry in terms of its ability to detect RPE cell damage caused by microsecond laser pulses of varying duration. Therefore, ex-vivo porcine RPE choroid sclera explants were embedded in an artificial eye and exposed to single laser pulses of 2–20 µs duration (wavelength: 532 nm, exposure area: 120 × 120 µm2, intensity modulation factor: 1.3). Simultaneously, time-resolved OCT M-scans were recorded (central wavelength: 870 nm, scan rate: 33 kHz). Post-irradiation, RPE cell damage was quantified using a calcein-AM viability assay and compared with an OCT-dosimetry algorithm. The results of our experiments show that the OCT-based analysis successfully predicts RPE cell damage. At its optimal operating point, the algorithm achieved a sensitivity of 89% and specificity of 94% for pulses of 6 µs duration and demonstrated the ability to precisely control radiant exposure of a wide range of pulse durations towards selective real-time laser microsurgery.
Neovascular age-related macular degeneration is one of the leading causes of blindness. Microglia and macrophages play a critical role in choroidal neovascularization (CNV) and may, therefore, be potential targets to modulate the disease course. This study evaluated the effect of the colony-stimulating factor-1 receptor inhibitor PLX5622 on experimental laser-induced CNV. A 98% reduction of retinal microglia cells was observed in the retina 1 week after initiation of PLX5622 treatment, preventing accumulation of macrophages within the laser site and leading to a reduction of leukocytes within the choroid after CNV induction. Mice treated with PLX5622 had a significantly faster decrease of the CNV lesion size, as revealed by in vivo imaging and immunohistochemistry from day 3 to day 14 compared with untreated mice. Several inflammatory modulators, such as chemokine (C-C motif) ligand 9, granulocyte-macrophage colony-stimulating factor, soluble tumor necrosis factor receptor-I, IL-1 alpha, and matrix metallopeptidase-2, were elevated in the acute phase of the disease when microglia were ablated with PLX5622, whereas other cytokines (eg, interferon-gamma, IL-4, and IL-10) were reduced. Our results suggest that colony-stimulating factor-1 receptor inhibition may be a novel therapeutic target in patients with neovascular age-related macular degeneration.
Aim To report long-term outcomes on best-corrected visual acuity (BCVA) and treatment intervals with a treat-and-extend (T&E) regimen in patients with neovascular age-related macular degeneration (nAMD). Methods This observational study included treatment-naïve patients with nAMD, treated with aflibercept. A specific T&E protocol without a loading phase and predefined exit criteria was administered. After reaching predefined ‘exit-criteria’, the treatment period was complete, and patients were observed three monthly. Results Eighty-two patients with a follow-up period of ≥2 years were included. BCVA (mean±SD, ETDRS letters) increased from 51.9±25.2 at baseline to 63.7±17.7 (p<0.0001) at 1 year, 61.7±18.5 (p<0.0001) at 2 years, 62.4±19.5 (p<0.0001, n=61) at 3 years and remained insignificantly higher than baseline at 4 years at 58.5±24.3 (p=0.22). Central subfield thickness (mean±SD, μm) decreased significantly from 387.5±107.6 (p<0.0001) at baseline to 291.9±65.5 (p<0.0001) at 1 year, and remained significantly lower until 4 years at 289.0±59.4 (p<0.0001). Treatment intervals (mean±SD, weeks) could be extended up to 9.3±3.1 weeks at 1 year and remained at 11.2±3.5 weeks at 4 years. Twenty-nine (35%) patients reached exit criteria and continued with three monthly observation only. Conclusions After 4 years of treatment, initial vision gains were maintained with a reasonable treatment burden, even without an initial loading phase. Our results on functional outcomes are comparable with large controlled studies.
To compare drusen volume between Heidelberg Spectral Domain (SD-) and Zeiss Swept-Source (SS) PlexElite Optical Coherence Tomography (OCT) determined by manual and automated segmentation methods. Thirty-two eyes of 24 patients with Age-Related Macular Degeneration (AMD) and drusen maculopathy were included. In the central 1 and 3 mm ETDRS circle drusen volumes were calculated and compared. Drusen segmentation was performed using automated manufacturer algorithms of the two OCT devices. Then, the automated segmentation was manually corrected and compared and finally analyzed using customized software. Though on SD-OCT, there was a significant difference of mean drusen volume prior to and after manual correction (mean difference: 0.0188 ± 0.0269 mm3, p < 0.001, corr. p < 0.001, correlation of r = 0.90), there was no difference found on SS-OCT (mean difference: 0.0001 ± 0.0003 mm3, p = 0.262, corr. p = 0.524, r = 1.0). Heidelberg-acquired mean drusen volume after manual correction was significantly different from Zeiss-acquired drusen volume after manual correction (mean difference: 0.1231 ± 0.0371 mm3, p < 0.001, corr. p < 0.001, r = 0.68). Using customized software, the difference of measurements between both devices decreased and correlation among the measurements improved (mean difference: 0.0547 ± 0.0744 mm3, p = 0.02, corr. p = 0.08, r = 0.937). Heidelberg SD-OCT, the Zeiss PlexElite SS-OCT, and customized software all measured significantly different drusen volumes. Therefore, devices/algorithms may not be interchangeable. Third-party customized software helps to minimize differences, which may allow a pooling of data of different devices, e.g., in multicenter trials.
The aim of this observational study was to assess the use and outcome of intravitreal aflibercept in a treat and extend regimen in treatment-naïve neovascular AMD patients in routine practice. This both retrospective and prospective study was conducted in four larger Swiss retina clinics (ASTERIA study). The primary endpoint was the mean change in best-corrected visual acuity (BCVA) in ETDRS letters from baseline to 12 months. Between December 2017 and August 2018, 160 patients were included. For patients with available data, the mean change in BCVA was + 8.4 (± 14.4) letters at month 12 (n = 139) and + 5.0 (± 11.4) letters at month 24 (n = 95). A mean number of 8.3 (± 2.4) injections were administered within the first year and 5.4 (± 2.9) injections during the second year. On average, the observed treatment interval at month 12 was 63.3 (± 22.0) days and increased to 69.1 (± 28.6) days at month 24. For 37% of the patients, a treatment interval ≥ 12 weeks was attained at month 24. In conclusion, intravitreal aflibercept in a Swiss real-life treat and extend regimen resulted in comparable anatomic and functional outcomes as were observed in the prospective registration trials of aflibercept for nAMD treatment.