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Purpose Methods Results Conclusions To quantify ellipsoid zone (EZ) loss during anti‐VEGF therapy for neovascular age‐related macular degeneration (nAMD) and correlate these findings with nAMD disease activity using artificial intelligence‐based algorithms.Spectral domain optical coherence tomography (Spectralis, Heidelberg Engineering) images from nAMD treatment‐naïve patients from the Fight Retinal Blindness! (FRB!) Registry from Zürich, Switzerland were processed at baseline and over 3 years of follow‐up. An approved deep learning algorithm (Fluid Monitor, RetInSight) was used to automatically quantify intraretinal fluid (IRF), subretinal fluid (SRF) and pigment epithelial detachment (PED). An ensemble U‐net deep learning algorithm was used to automated quantify EZ integrity based on EZ layer thickness. The impact of fluid volumes on EZ thickness and late‐stages outcomes were calculated using Wilcoxon rank‐sum tests, a linear mixed model and a longitudinal panel regression model.Two hundred and eleven eyes from 158 patients were included. The mean ± SD EZ loss area in the central 6 mm was 1.81 ± 2.68 mm2 at baseline and reached 6.21 ± 6.15 mm2 at month 36. Higher fluid volumes (top 25%) of IRF and PED in the central 1 and 6 mm of the macula were significantly associated with more advanced EZ thinning and loss compared to the low fluid volume subgroup. The high SRF subgroup in the linear regression model showed no statistically significant association with EZ integrity in the central macula; however, the longitudinal analysis revealed an increased EZ thickness with no additional loss.Intraretinal fluid and PED volumes and their resolution pattern have an impact on alteration of the underlying EZ layer. AI‐supported quantifications are helpful in quantifying early signs of macular atrophy and providing individual risk profiles as a basis for tailored therapies for optimized visual outcomes. [ABSTRACT FROM AUTHOR]

Purpose: To evaluate the impact of the changes in treatment patterns before, during and after the COVID‐19 pandemic on best‐corrected visual acuity (BCVA) in previously treated neovascular age‐related macular degeneration (nAMD) patients. Methods: A multi‐centre, retrospective, observational study of consecutive nAMD patients during 2019–2021. Data collected included demographics, BCVA, dates of intravitreal anti‐vascular endothelial growth factor (anti‐VEGF) injections and clinic visits. Results: A total of 1652 eyes of 1652 nAMD patients were included, out of which 850 eyes were assessed in 2019 (pre‐COVID‐19), 630 eyes were assessed in 2020 (COVID‐19) and 974 eyes were assessed in 2021 (post‐COVID‐19). During the COVID‐19 period, the mean number of anti‐VEGF injections was significantly lower than the corresponding pre‐COVID‐19 and post‐COVID‐19 periods (5.55 compared to 6.13 and 6.60, respectively p < 0.01). A constant lower ratio of injections per patient/month was observed during COVID‐19 compared to previous and following years, with a notable decline during March–April, reaching a ratio of 0.4 in 2020 versus 0.65 in 2019 and 0.62 in 2021 (p < 0.01). Baseline BCVA (0.825, p < 0.001), number of injections (−0.007, p < 0.001), gender (−0.027, p = 0.037) and age (0.004, p < 0.001) were shown to be significant predictors of final BCVA. Conclusion: During the COVID‐19 period, patients were treated with significantly less intravitreal anti‐VEGF injection compared to the previous year with compensation in the following year. These changes in treatment patterns did not have a significant impact on BCVA outcomes. Age, gender, baseline BCVA and number of injections are predictors of final visual outcomes. [ABSTRACT FROM AUTHOR]

Purpose: To compare the 12 months visual and anatomical outcomes of treatment‐naïve neovascular age‐related macular degeneration (nAMD) patients diagnosed by optical coherence tomography angiography (OCT‐A) compared with fluorescein angiography (FA)/indocyanine green angiography (ICGA), after anti‐VEGF treatment in a real‐world setting. Methods: Monocentric, observational, parallel‐group study of nAMD patients diagnosed with either FA/ICGA or non‐invasive OCT‐A methods. Patients were treated with a fixed dosing regimen of intravitreal ranibizumab or aflibercept and followed up for 12 months. Primary outcomes were the 12 months functional (BCVA) and anatomical (CST reduction) gains between the two groups. The stratification of BCVA and CST gains by type of neovascular lesion and by anti‐VEGF treatment was also assessed. Results: Seventy‐two patients received FA/ICGA for the initial diagnosis of nAMD, while 73 received OCT‐A. Overall, the mean BCVA gain at 12 months was 11.5 ± 9.6 letters. There were no statistically significant differences between the invasive and non‐invasive imaging groups in BCVA gain (p = 0.87) or CST reduction (p = 0.76). No statistically significant outcome differences between different lesion types and the two drugs were observed. Conclusion: In a real‐world setting, nAMD patients diagnosed with OCT‐A showed meaningful improvements in visual and anatomical parameters during 12 months of treatment, without significant differences with those diagnosed by invasive modalities. [ABSTRACT FROM AUTHOR]

Background To study the visual outcomes of neovascular AMD (nAMD) treated with anti‐vascular endothelial growth factor (VEGF) drugs at national level. Methods: Multicenter national database of nAMD eyes treated with anti‐VEGF intravitreal injections (ranibizumab, aflibercept, bevacizumab) in fixed bimonthly (FB) or treat‐and‐extend (TAE) regimens. Demographics, visual acuity (VA) in logarithm of the minimum angle of resolution (logMAR) ETDRS letters at baseline and subsequent visits, number of injections and visits data were collected using a validated web‐based tool (Fight Retinal Blindness!). Results: 1273 eyes (1014 patients) were included, 971 treatment naïve (TN) and 302 previously treated (PT). Baseline VA (mean ± SD) was 57.5 (±19.5) and 62.2 (±17) (p > 0.001), and 24 months final VA was 60.4 (±21.2) and 58.8 (±21.1) (p = 0.326), respectively. Mean VA change at 12/24 months was +4.2/+2.9 letters in TN eyes and +0.1/−3.4 letters in PT eyes (p < 0.001/p < 0.001). The percentage of ≥15 letters gainers/losers at 24 months was 24.8%/14.5% in TN, and 10.3%/15.7% in PT eyes. The median number of injections/visits at 12 months was 7/9 in TN and 6/8 in PT (p = 0.002/p < 0.001) and at 24 months was 11/16 in TN and 11/14 in PT (p = 0.329/p < 0.001). Study drugs included ranibizumab (39.5%), aflibercept (41.2%) and bevacizumab (19.3%). Conclusion: Independent, large‐scale national audits are feasible if committed health care professionals are provided with efficient information technology systems to do them. The results described here represent an adequate measurement of the quality of care delivered nationwide and benchmark the clinical management of nAMD at a country level compared to other real‐world international cohorts. [ABSTRACT FROM AUTHOR]

Purpose: The number of patients receiving anti‐VEGF therapy has increased rapidly since its introduction in Denmark in 2007, placing an enormous pressure on the public healthcare system. In this study, we attempt to describe this growth and identify the factors driving it. Methods: Data on treatment of the entire population of neovascular AMD patients in the Capital Region of Denmark between 2007 and 2019 was retrieved. The age and sex standardized incidences of first time treatment and changes in duration of treatment were analysed. Results: The number of patients in active treatment increased from 576 in 2007 to 3684 in 2019. The growth was initially driven by accumulation of patients continuing anti‐VEGF therapy for extended periods of time (259 patients/year). As larger numbers of patients began to be discharged, the increase slowed to 181 patients/year in late 2010s, with demographic change becoming the main growth driving factor. The incidence of first treatment increased slightly during the study period, mainly for individuals over 85 years. For patients under 85 years, treatment incidences closely followed neovascular AMD incidences from population studies. The likelihood of remaining in anti‐VEGF treatment after the initial injection followed exponential decay curve (t1/2 = 3.6 years). Based on this observation, a model was created to describe the number of patients in active treatment, which accurately described historical data (R2 = 0.999), and forecast a linear growth of 138 patients/year until 2030. Conclusion: Treatment incidences and modelling reported in this study might facilitate a more informed and accurate planning of future ophthalmology services. [ABSTRACT FROM AUTHOR]

Purpose: To evaluate treatment outcome at 12 months in eyes with neovascular age‐related macular degeneration (nAMD) treated with antivascular endothelial growth factor (anti‐VEGF) injections according to either pro re nata (PRN)‐ or treat‐and‐extend (TE)‐regimen in one clinical setting in Sweden. Methods: Data were obtained retrospectively from the Swedish Macula Register, optical coherence tomography‐database and electronic patient charts. The study included 443 eyes; 223 PRN‐ and 220 TE‐treated eyes. Baseline (BL) characteristics and follow‐up data at 6 and 12 months were collected. Statistical regression analysis was performed to evaluate association between treatment strategy and visual outcome at 12 months. Results: Baseline (BL) characteristics were well balanced between cohorts. Visual acuity at 12 months was higher in TE‐cohort 66.5 (13.1) compared to PRN‐cohort 60.1 (17.6) (p = 0.000). Visual improvement at 12 months was +5.2 (11.8) and +1.2 (12.7) letters Early Treatment Diabetic Retinopathy Study (ETDRS) in TE‐ and PRN‐cohorts, respectively (p = 0.002). Number of administered injections at 12 months was 10.2 (2.1) and 6.3 (2.1) in the two cohorts (p = 0.000). Statistical analysis demonstrated a strong association between TE treatment strategy and improvement in visual acuity at 12 months. Conclusion: Eyes treated according to TE had better visual outcome at 12 months. The results indicate that treatment according to proactive TE‐regimen is superior to treatment according to PRN‐regimen in clinical routine care of nAMD. [ABSTRACT FROM AUTHOR]

Purpose: To assess mean change in visual acuity (VA) overall and stratified by baseline VA after 1 and 2 years' treatment with aflibercept in a real‐life setting. Methods: This was an observational cohort study using nationwide data from the Swedish Macula Register. Treatment‐naïve patient eyes with wet age‐related macular degeneration and prescribed aflibercept from January 2013 to December 2014 were followed for 1 year (2478 eyes) or 2 years (831 eyes) to assess VA. Eyes were grouped by baseline VA. Results: Mean number of injections in patients treated according to label (72%) versus patients treated not according to label was 8.0 ± 1.5 versus 4.4 ± 0.8 (p < 0.0001) at 1 year, and 12.5 ± 3.2 versus 7.3 ± 1.9 (p < 0.0001) at 2 years. Among all eyes, mean VA increased from 61.3 ± 13.4 Early Treatment Diabetic Retinopathy Study letters at baseline to 64.5 ± 15.6 at 1 year and 65.1 ± 15.1 letters at 2 years. At 2 years, eyes with good baseline vision (≥70 letters) lost a mean of 2.4 ± 11.3 to 72.3 letters, eyes with intermediate baseline VA (36–69 letters) gained 5.7 ± 14.1 to 62.7 letters, and eyes with poor baseline VA (≤35 letters) gained 13.2 ± 18.3 to 41.0 letters. Also at 2 years, 75% of treated eyes were stable or had improved VA. Among eyes with intermediate baseline VA, near vision was significantly better among those treated according to label versus not according to label at 3 (p = 0.019), 6 (p = 0.0002) and 12 months (p ≤ 0.0001). Conclusion: While gain in vision was especially pronounced in eyes with poor baseline VA, good baseline VA was important for best prognosis. [ABSTRACT FROM AUTHOR]

Purpose: To analyse the mortality associated with intravitreal injections of bevacizumab for age‐related macular degeneration (AMD) in patients previously diagnosed with stroke or transient ischaemic attack (TIA). Methods: We reviewed bevacizumab‐treated AMD patients with a diagnosis of stroke or TIA prior to their first bevacizumab injection (n = 948). Those patients, naïve to any anti‐vascular endothelial growth factor (anti‐VEGF) at the time of stroke/TIA, were then compared to age‐ and gender‐matched patients who had a stroke/TIA at the same time and had never been exposed to anti‐VEGF. Survival analysis was performed using adjusted Cox regression. The main outcome measure was survival. Adjusted variables were age, smoking, alcohol abuse, hypertension, diabetes mellitus, obesity, ischaemic heart disease, congestive heart failure and liver cancer. Results: Age and gender distribution of bevacizumab‐treated patients and controls were similar (mean age: 83.4 versus 83.7 years, p = 0.3; 51.7% males versus 52.5% males, p = 0.7). The adjusted mortality in patients who received bevacizumab within 3 months after stroke/TIA was significantly different than in patients non‐exposed to bevacizumab (OR = 6.92, 95%, CI 1.88–25.43, p < 0.01). Within 6 months after stroke/TIA, the difference in adjusted mortality showed a strong trend (OR = 2.00, 95%, CI 0.96–4.16, p = 0.064). Within 12 months, it was insignificant (OR = 1.30, 95%, CI 0.75–2.26, p = 0.348). Conclusion: We found increased mortality within three months after a cerebrovascular event in patients treated with bevacizumab for AMD compared to patients for whom there was no record of a prescription to any anti‐VEGF agent. [ABSTRACT FROM AUTHOR]

Purpose To present Swedish Macula Register (SMR) data regarding treatment of neovascular age-related macular degeneration (AMD) in clinical practice since 2008. Methods A retrospective register-based study was conducted. Evaluation of baseline demographics, visual outcome and number of injections during this period is presented. Results Mean age at diagnosis was 79 ± (SD) 8 years; 65% were female. The proportion of patients with <2 months' duration of symptoms increased from 26% in 2008 to 41% in 2014 (p = 0.001). Mean visual acuity (VA) at baseline increased from 54.3 ± 15.0 early treatment diabetic retinopathy study (ETDRS) letters in 2008 to 57.8 ± 15.6 letters in 2014 (CI95 2.6; 4.3; p < 0.001). Mean VA after 1 year of treatment increased from 57.8 ± 17.7 ETDRS letters for patients who started the treatment in 2008 to 62.8 ± 16.4 ETDRS letters in patients starting treatment in 2014 (CI95 2.67; 4.64; p < 0.001). During all study years, the proportion of patients with an improvement in VA of between 5 and 15 letters was around 30%, while 14% had VA improvement of more than 15 letters. The mean number of injections during the first treatment year increased from 4.3 ± 1.9 in 2008 to 5.9 ± 2.9 in 2014 (CI95 1.40; 1.67; p < 0.001). Seven-year follow-up of 322 eyes showed a mean change of −1 letters from baseline, with a mean of 21 injections for the entire period. Conclusion The duration of symptoms before treatment decreased, while VA at baseline and after 1 year of treatment increased over the years and so did the number of injections. Long-term follow-up demonstrated stable VA. [ABSTRACT FROM AUTHOR]

Purpose To examine the outcome after cataract surgery in patients with neovascular age-related macular degeneration (AMD) treated with intravitreal anti-vascular endothelial growth factor (VEGF) injections in routine clinical practice. Methods We extracted information about patients recorded in electronic databases managing anti-VEGF injections and cataract surgery. We compared Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity and frequency of anti-VEGF injections before and after cataract surgery. Results We identified 89 eyes from 89 patients who had cataract surgery after being treated with a median of 10 (range 3-36) anti-VEGF injections for neovascular AMD. Visual acuity improved by a mean of 7.1 [95% confidence interval (CI) 4.6-9.6] ETDRS letters in the first 6 months after cataract surgery. The need of anti-VEGF injections did not change after cataract surgery with an average of 1.5 in the 6 months before surgery versus 1.7 in the 6 months after surgery (p = 0.25). Visual improvement was greater in patients when the time from latest injection to cataract surgery was lower. Conclusions Cataract surgery improves vision in patients undergoing treatment for neovascular AMD. Cataract surgery was not associated with an increased need for anti-VEGF treatment and patients who were in active anti-VEGF treatment had better visual outcomes than patients who had cataract surgery after long injection-free periods. [ABSTRACT FROM AUTHOR]

Purpose The HELIOS (Health Economics with Lucentis in Observational Settings) study was designed on request of the Dutch Health Authority for an observational study to assess the effectiveness and safety of ranibizumab for neovascular age-related macular degeneration (wet AMD) in daily practice. Methods The HELIOS study was a 2-year prospective, observational, open-label, multicentre study involving 14 sites. Patients with wet AMD were enrolled and observed for a period of 24 months. The data were collected at baseline and at the visits closest around the time-points 3, 6, 12, 18 and 24 months after inclusion. Results Treatment with ranibizumab resulted in prevention of vision loss. The mean ETDRS score increased from 45.1 letters at baseline to 48.5 letters at 24 months. This was achieved with a mean of 7.8 injections over 24 months. Stabilization of visual acuity was also reflected by the scores on the quality of life EQ-5D questionnaire, which did not significantly change over the study period. The more subjective EQ- VAS questionnaire showed an overall improvement. The VFQ-25 questionnaire was also mostly stable over time. After 24 months, 32.2% of the patients gained ≥1 letter and 17.1% gained >15 letters. Patients completing the loading phase were better responders, as demonstrated by increased long-term visual acuity. In addition, ranibizumab was well tolerated and had a safety profile commonly seen in routine clinical practice. Conclusion This study demonstrates that also in daily practice ranibizumab was effective in preventing vision loss over a period of 24 months. No new safety findings were identified. [ABSTRACT FROM AUTHOR]

. Purpose: Quantification of short-term progression of active neovascular age-related macular degeneration and correlation with 1-year outcome. Methods: Sixty-five patients with newly diagnosed treatment-naive active subfoveal choroidal neovascularization (CNV), who had participated in clinical trials testing anti-vascular endothelial growth factor therapy, were retrospectively assessed. Early Treatment Diabetic Retinopathy Study best-corrected visual acuity (BCVA), Spectral Domain Optical Coherence Tomography (SD-OCT) and fluorescein angiography (FA) were performed twice during the pretreatment period. Changes in BCVA, central retinal thickness (CRT), average macular thickness (AMT) and leakage area were documented within this pretreatment period for all patients and for lesion type I (occult CNV, n = 42) and type II (classic CNV, n = 23). Three-month and 1-year BCVA were then correlated with the pretreatment period. Results: The pretreatment period was 19 ± 3 days (range: 2-108). Neither type I nor type II lesions showed a significant BCVA decrease or CRT/AMT increase during this period. On FA, mean leakage area increased significantly during the pretreatment period: in the pooled group from 5.50 ± 0.62 (screening) to 7.60 ± 0.86 mm2 (baseline) (p < 0.0001), in type II from 4.65 ± 0.90 to 7.83 ± 1.62 mm2 (p < 0.01) and in type I from 6.08 ± 0.85 to 7.45 ± 0.96 mm2 (p < 0.0001). The mean increase in leakage area per day was 0.046 ± 0.02 mm2, p = 0.034. Type II showed a daily growth of 0.09 ± 0.08 mm2 (p < 0.042) and type I 0.045 ± 0.008 mm2 per day (p < 0.0001). However, neither leakage area increase nor pretreatment period was correlated with 3-month or 1-year BCVA outcome. Conclusions: SD-OCT and BCVA testing did not reveal deterioration during the pretreatment period. However, the leakage area progressed rapidly. Despite the rapid increasing leakage area, the 19-day waiting period was not associated with a poorer visual outcome at 3 months and 1 year. [ABSTRACT FROM AUTHOR]