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A remarkable proportion of neovascular age-related macular degeneration (nAMD) patients respond rather poorly to ranibizumab treatment, in spite of the minimum 4-week follow-up and treatment interval. Usually, retreatments are based on nAMD activity as evaluated by Spectral-domain Optical coherence Tomography (SD-OCT), biomicroscopic fundus examination and visual acuity changes. In this prospective pilot study, we aimed to study SD-OCT changes in a high-frequent follow-up manner (weekly (month 0–6), biweekly (month 7–12)) throughout the first year, which consequently led to intravitreal ranibizumab being administered up to biweekly. Best corrected visual acuity (BCVA) was already significantly improved at week 2. Central retinal thickness (CRT), intraretinal and subretinal fluid (SRF) were significantly improved from week 1 onwards. Half of the patients showed nAMD activity at week 2 or 3 and received the first retreatment earlier than 4 weeks after baseline injection. In total, 46% of retreatments were already applied 2 or 3 weeks after the previous treatment. Greater range of CRT and SRF fluctuation during follow-up was associated with lower final BCVA. Lower baseline BCVA and better SRF improvement at week 2 was associated with greater BCVA improvement. In conclusion, high-frequency SD-OCT follow-up provided a good option for adapting treatment in nAMD individually.

AimsTo demonstrate non-inferiority of ranibizumab treat-and-extend (T&E) with/without laser to ranibizumab pro re nata (PRN) for best-corrected visual acuity (BCVA) in patients with diabetic macular oedema (DMO).MethodsA 24-month single-masked study with patients randomised 1:1:1 to T&E+laser (n=121), T&E (n=128) or PRN (control; n=123). All patients received monthly injections until BCVA stabilisation. The investigator decided on re-treatment in the PRN and treatment-interval adaptations in the T&E groups based on loss of BCVA stability due to DMO activity. Likewise, laser treatment was at investigator's discretion. Collectively, these features reflect a real-life scenario. Endpoints included mean average change in BCVA from baseline to months 1–12 (primary), mean BCVA change from baseline to months 12 and 24, treatment exposure and safety profile.ResultsBoth T&E regimens were non-inferior to PRN based on mean average BCVA change from baseline to months 1–12 (T&E+laser: +5.9 and T&E: +6.1 vs PRN: +6.2 letters; both p<0.0001). Mean BCVA change at month 24 was similar across groups (+8.3, +6.5 and +8.1 letters, respectively). The mean number of injections was 12.4 and 12.8 in the T&E+laser and T&E groups and 10.7 in the PRN group. The T&E regimens showed 46% reduction in the number of clinic visits. Over 70% of patients maintained their BCVA, with treatment intervals of ≥2 months over 24 months. Safety profile was consistent with that described in the product information.ConclusionsT&E is a feasible treatment option for patients with DMO, with a potential to reduce treatment burden. Slightly more injections were required versus PRN, likely due to the specifics of the T&E regimen applied here.Trial registration numberNCT01171976.

Background Anti-vascular endothelial growth factor (VEGF) intravitreal injection treatment (IVT)s are gold standard for various neovascular retinal diseases, including neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME), and macular edema due to retinal vein occlusion (RVO). Same day bilateral IVTs are commonly performed off-label worldwide to reduce patient burden, despite limited safety data. This study evaluates the safety and management of bilateral same day anti-VEGF injections within a treat-and-extend regimen (TER) and proposes a clinical guideline for coordination of bilateral treatment. Methods This retrospective observational study analysed electronic health records of 428 included patients treated bilaterally with ranibizumab 0.5mg or aflibercept 2mg at the VISTA Augenklinik (Binningen, Switzerland) between 2015 and 2019. Patients included had bilateral macular edema due to nAMD, DME, or RVO and received at least two cycles of same day bilateral anti-VEGF injections within the TER. Treatment coordination followed one of four strategies: Equal TER, Coordinated TER, Mixed TER and pro re nata (PRN), and Asynchronous TER. Unilateral IVTs were also recorded during the same period in the same patient cohort. Ocular and systemic adverse events (AEs) were compared between unilateral and bilateral injections using Fisher’s exact test. Results A total of 15,825 anti-VEGF injections were administered: 4,766 bilateral same day injections ( ) and 6,293 unilateral injections. Treatment intervals were synchronised according to visual acuity potential and disease activity. A treatment regime for bilateral IVTs has been established and is provided in the manuscript. The most frequently reported ocular AEs were conjunctival haemorrhage and sicca symptoms. Systemic AEs such as cerebrovascular and cardiovascular events were rare, with no significant difference between bilateral and unilateral injections. Conclusion Bilateral same day intravitreal anti-VEGF injections within a TER regimen appear to be safe with no significant increase in ocular or systemic AEs compared to unilateral treatment. Coordinating bilateral IVTs using the clinical guideline presented in this study may reduce treatment visits, ease patient burden and improve compliance. Larger prospective studies are needed to confirm safety and support standardised guidelines for bilateral IVTs.

The use of anti-vascular-endothelial growth factor agents for neovascular age-related macular degeneration (nAMD) in different treatment schemes is widely common in clinical practice. However, there is currently limited data on the long-term outcomes of a strict treat-and-extend regimen (TER) and imaging biomarkers to predict both functional outcome and the potential for a TER exit due to success. In this retrospective study we followed treatment-naïve subjects with nAMD starting treatment with either ranibizumab or aflibercept in a TER without loading dose but with predefined exit criteria for up to 8 years. We evaluated both the functional outcome and several spectral-domain optical coherence tomography parameters in a follow-up mode using a standardized protocol. Within the 211 eyes followed for a mean of 60.3 ± 20.9 months, follow-up adherence was high with major part of discontinuations of TER being due to success. Mean best-corrected visual acuity (BCVA) increased from initially 63.9 ± 15.5 ETDRS letters to 70.0 ± 14.7 after 1 year (+6.1 letters, p < 0.001) and to 68.5 ± 18.1 (+4.6 letters, p = 0.028) at 5 years. A worse BCVA ( p = 0.001) and a better external limiting membrane (ELM) disruption score at baseline predicted ( p = 0.019) BCVA gain at 5 years. The probability of reaching the exit criteria was significantly associated with a better ELM disruption score ( p = 0.044) and the absence of a central pigment epithelial detachment (PED) ( p = 0.05) at baseline. Significant visual gains were sustained in a long-term TER in a real-world setting. Integrity of ELM at baseline predicted BCVA gain at 5 years and the potential for TER exit due to success.

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.

To assess the ability of two self-monitoring digital devices to detect metamorphopsia in myopic choroidal neovascularization (mCNV) and compare their usability. This was a 12-month prospective observational study at a tertiary care eye hospital, Switzerland. Twenty-three Caucasian patients with mCNV were recruited, 21 eyes were analyzed. Primary and secondary outcome measures: Primary outcome measures were the metamorphopsia index scores as assessed by the two self-monitoring digital devices (Alleye App and AMD - A-Metamorphopsia-Detector software) at baseline, at 6 and 12 months and individual optional visits in between. Secondary outcome measures included best corrected visual acuity and morphological parameters (including disease activity) as evaluated by spectral-domain optical coherence tomography and fundus autofluorescence imaging. Location of mCNV was graded using the Early Treatment of Diabetic Retinopathy Study grid overlay. A usability questionnaire was administered at 12 months. Bland-Altman plots evaluated the limits of agreement of both devices. Linear regression analysis assessed the correlation between the difference and the average of the two scores. A total of 202 tests were performed. Disease activity of mCNV was observed at least once in 14 eyes. Both scores concordantly detected metamorphopsia exhibiting a displaced scale of measurement yielding a coefficient of determination of 0.99. Concordance rate for pathological scores was 73.3%. Both scores were not significantly different in active and inactive mCNV. Overall, the usability scores were higher for the Alleye App than the AMD - A-Metamorphopsia-Detector software (4.61±0.56 vs 3.31±1.20; p<0.001). In subjects aged >75 years, scores were slightly lower (4.08±0.86 vs 2.97±1.16; p= 0.032). Whilst both self-monitoring devices concordantly identified metamorphopsia, they might act as an adjunct to hospital visits, but due to slight reactivations in mCNV and presence of metamorphopsia also in inactive disease the ability of detecting early mCNV activity might be limited.

Irvine–Gass syndrome (IGS) is a macular edema that is mostly observed after cataract surgery, also known as pseudophakic cystoid macular edema (PCME). To date, there are still no standardized guidelines for its treatment. Background/Objectives: This study aimed to compare the efficacy of local and systemic treatments on the resolution of Irvine–Gass Syndrome as well as the therapeutic outcomes of patients with known risk factors such as diabetes and arterial hypertension in order to be able to personalize treatment regimens for each patient. Methods: A total of 136 eyes were followed for a mean of 9.7 ± 15.2 months, with patients divided as follows: those who received only local treatment (LT), those who received systemic treatment (ST), those with cardiovascular diseases (CV), and those without cardiovascular diseases (NCV). We compared the time from the diagnosis of IGS to fully recovered edema (no sub- or intraretinal fluid), central subfield thickness (CST, as evaluated using optical coherence tomography), visual acuity (VA), and intraocular pressure (IOD) in each group. The time from diagnosis to resolution was measured from the initiation of therapy to the full resolution of edema. Results: A total of 136 eyes were examined. The mean CST significantly decreased in the LT (n = 75) (458.3 ± 96.5 µm to 320 ± 39.5 µm (p < 0.01)) and ST (n = 61) groups (519.3 ± 121.6 µm to 337.2 ± 70.6 µm (p < 0.01)) from baseline to 12 months, with no significant difference (p = 0.92). The mean VA significantly increased in both groups from baseline to 12 months (LT: 69.1 ± 11.9 to 80.4 ± 6.6 letters (p < 0.01); ST: 65.1 ± 11.8 to 78.5 ± 6.8 letters (p < 0.01)). The mean time to the resolution of edema was significantly shorter in the LT group (p < 0.05). There were no significant differences in the CST decrease, VA gain, or time to edema resolution between the CV and NCV patients. Conclusions: In regard to the non-inferiority of local treatment, a personalized approach for each patient should be considered, and systemic treatment must be critically evaluated to determine possible side effects.

To investigate the peripapillary and macular microvasculature in neovascular age-related macular degeneration (nAMD) in recently started versus long-term anti-vascular endothelial growth factor (VEGF) therapy and healthy controls. Eyes with nAMD treated in a treat-and-extend regimen were assigned to group 1 (<5 injections) or 2 (≥20 injections) whereas group 3 constituted the healthy age-matched controls. Blood flow signals were acquired using PLEX Elite 9000 swept-source optical coherence tomography angiography (OCTA) of the macular and peripapillary regions. Mean ganglion cell complex (GCC) thickness values were quantified using spectral-domain optical coherence tomography (SD-OCT). Including 80 eyes whereof 40 controls, macular superficial perfusion density was significantly reduced in group 1 and 2 compared to controls ( < 0.001; = 0.010) without a difference between groups 1 and 2. Peripapillary perfusion parameters did not correlate with post-operative intraocular pressure (IOP) or number of anti-VEGF injections. Mean peripapillary flux index was significantly lower in group 2 than in controls ( = 0.023) and significantly decreased in the nasal quadrants for both AMD groups compared to group 3 ( = 0.013; < 0.001). Mean peripapillary perfusion density was significantly reduced in both AMD groups compared to controls (0.515 ± 0.02 versus 0.556 ± 0.03, < 0.0001). Frequency of anti-VEGF treatment in nAMD and post-operative IOP showed no correlation with peripapillary perfusion parameters, but anti-VEGF treated nAMD patients exhibited partly altered peripapillary perfusion compared to healthy controls. Reduced macular perfusion density of the inner retina in anti-VEGF treated nAMD compared to healthy controls might be discussed as an anti-VEGF treatment effect or a characteristic of nAMD.

Background Monitoring for potential inflammatory events following intravitreal anti-vascular endothelial factor (VEGF) injection is crucial with the use of new agents such as aflibercept 8 mg. Despite a safety profile comparable to aflibercept 2 mg in pivotal and phase 3 studies, reporting such cases in clinical practice helps evaluate potential risk of these agents. Case presentation In this case series, a cluster of 8 patients manifesting acute intraocular inflammation (IOI) after intravitreal aflibercept 8 mg injection at three different centers are described. All patients developed inflammation of the vitreous and anterior chamber within 2–17 days following the injection. All subjects had previously received intravitreal anti-vascular endothelial growth factor (VEGF) therapy (ranibizumab, aflibercept 2 mg or faricimab) without injection-related complications. No signs of vasculitis, papillitis or retinitis were noted. In view of the clinical presentation, vitreous cultures were not performed. Inflammation resolved with topical steroids and non-steroidal anti-inflammatory drugs over a course of 11–24 days with excellent visual recovery. Conclusions We report a cluster of injection-related ocular inflammation following intravitreal aflibercept 8 mg with at present unknown cause. It underlines the need for clinical awareness to detect such cases despite the low-risk safety profile in pivotal studies.

Several adjunct therapies to the gold standard anti-vascular endothelial growth factor (anti-VEGF) intravitreal injections have been discussed for the treatment of neovascular age-related macular degeneration (nAMD). Low-dose stereotactic radiotherapy (SRT) showed the potential to lower the treatment burden by reducing the anti-VEGF treatment frequency at least over 2–3 years but was associated with retinal microvascular abnormalities in a few cases. We report a 6-year follow-up of a case with bilateral nAMD under anti-VEGF treatment which developed multiple polypoid choroidal vasculopathy (PCV) lesions in the eye adjunct treated with low-dose SRT. The fellow eye suffering from nAMD for the same period of time but never been treated with SRT did not show PCV during the long-term follow-up. We hope to increase the awareness of possible choroidal changes such as PCV in similar patients by sharing this report.