Rationale and Design of VOYAGER: Long-term Outcomes of Faricimab and Port Delivery System with Ranibizumab for Neovascular Age-Related Macular Degeneration and Diabetic Macular Edema in Clinical Practice.

Purpose: To describe the rationale and design of the VOYAGER (NCT05476926) study, which aims to investigate the safety and effectiveness of faricimab and the Port Delivery System with ranibizumab (PDS) for neovascular age-related macular degeneration (nAMD) or diabetic macular edema (DME) in clinical practice. VOYAGER also aims to understand drivers of clinical practice treatment outcomes by gaining novel insight into the intersection of treatment regimens, decisions, anatomic outcomes, and vision. Design: Primary data collection, noninterventional, prospective, multinational, multicenter clinical practice study. Participants: At least 5000 patients initiating/continuing faricimab or PDS for nAMD/DME (500 sites, 31 countries). Methods: Management will be per usual care, with no mandated scheduled visits/imaging protocol requirements. Using robust methodologies, relevant clinical and ophthalmic data, including visual acuity (VA), and data on treatment clinical setting/regimens/philosophies, presence of anatomic features, and safety events will be collected. Routinely collected fundus images will be uploaded to the proprietary Imaging Platform for analysis. An innovative investigator interface will graphically display the patient treatment journey with the aim of optimizing treatment decisions. Main Outcome Measures: Primary end point: VA change from baseline at 12 months per study cohort (faricimab in nAMD and in DME, PDS in nAMD). Secondary end points: VA change over time and per treatment regimens (fixed, treat-and-extend, pro re nata, and other) and number. Exploratory end points: VA change in relation to presence/location of anatomic features that impact vision (fluid, central subfield thickness, fibrosis, atrophy, subretinal hyperreflective material, diabetic retinopathy severity, and disorganization of retinal inner layers) and per treatment regimen/philosophies. The impact of regional and practice differences on outcomes will be assessed as will safety. Results: Recruitment commenced in November 2022 and will continue until late 2027, allowing for up to 5 years follow-up. Exploratory interim analyses are planned annually. Conclusions: VOYAGER is an innovative study of retinal diseases that will assess the effectiveness and safety of faricimab and PDS in nAMD and DME and identify clinician- and disease-related factors driving treatment outcomes in clinical practices globally to help optimize vision outcomes. Financial Disclosures: Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Astigmatism Influences Quantitative and Qualitative Analysis in Optical Coherence Tomography Angiography Imaging.

Purpose: The purpose of this paper was to study the influence of astigmatism in optical coherence tomography angiography (OCTA) images in a quantitative and qualitative analysis. Methods: This was a prospective, cross-sectional study. We included 110 eyes of 110 patients: 20 eyes without astigmatism and 90 eyes with astigmatism ≥0.5 diopters (D). We performed a macula centered OCTA as a reference image. In patients without astigmatism, registered follow-up scans were performed after induction of -1 and -2 D astigmatism. In patients with astigmatism, we performed the follow-up scan after astigmatism correction. We used a set of cylindrical lenses attached to the camera head of the SPECTRALIS (Heidelberg Engineering, Heidelberg, Germany). A quantitative and qualitative analysis of the superficial vascular complex (SVC) and deep vascular complex (DVC) was performed. The main outcome measures were vessel density (VD), image quality, and the presence of artifacts. Results: Mean VD of the SVC was significantly higher in the reference images compared with the images after induction of -2 D. Differences with -1 D were nonsignificant. Higher degrees of astigmatisms had higher VD dropout (0.012-0.02 per diopter in SVC). Astigmatism axis showed no relevance in our cohort. Image quality assessed by two independent observers was graded as higher in images without astigmatism. Defocus and attenuation were more prevalent in images with astigmatism. Conclusions: Astigmatism of -2 D affects quantification of VD in OCTA images, mainly affecting the SVC, as well as the subjective quality assessment. Correction of this refractive error might be necessary for an accurate quantitative assessment of OCTA images. Translational Relevance: Correcting astigmatism of 2 D or greater appears to be necessary when analyzing OCTA images.

Optical coherence tomography biomarkers in early and intermediate age-related macular degeneration: A clinical guide.

Advanced forms of age-related macular degeneration (AMD), characterised by atrophic and neovascular changes, are a leading cause of vision loss in the elderly population worldwide. Prior to the development of advanced AMD, a myriad of risk factors from the early and intermediate stages of AMD have been published in the scientific literature over the last years. The ability to precisely recognise structural and anatomical changes in the ageing macula, altogether with the understanding of the individual risk implications of each one of them is key for an accurate and personalised diagnostic assessment. The present review aims to summarise updated evidence of the relative risk conferred by diverse macular signs, commonly seen on optical coherence tomography, in terms of progression to geographic atrophy or macular neovascularization. This information may also serve as a basis for tailored follow-up monitoring visits.

Macular Neovascularization Type Influence on Anti-VEGF Intravitreal Therapy Outcomes in Age-Related Macular Degeneration.

PURPOSE: To evaluate the influence of macular neovascularization (MNV) lesion type on 12-month clinical outcomes in treatment-naive eyes with neovascular age-related macular degeneration (nAMD) treated with anti-VEGF drugs nationwide. DESIGN: Multicenter national nAMD database observational study. SUBJECTS: One thousand six hundred six treatment-naive nAMD eyes (1330 patients) undergoing anti-VEGF therapy for 12 months nationwide. METHODS: Demographics, visual acuity (VA) in logarithm of the minimum angle of resolution letters, number of injections and visits were was collected using a validated web-based tool. Neovascular lesion phenotype was classified as type 1 (T1, n = 711), type 2 (T2, n = 505), type 3 (T3, n = 315), and aneurysmal type 1 (A-T1, n = 75), according to the new proposed consensus classification. MAIN OUTCOME MEASURES: Mean VA change at 12 months, final VA at 12 months, number of injections, time to lesion inactivation. RESULTS: A total of 1606 treatment-naive nAMD eyes (1330 patients) received a median of 7 injections over 12 months. Mean (± standard deviation) baseline VA was significantly lower for T2 (49.4 ± 23.5 letters) compared with T1 (57.8 ± 20.8) and T3 (58.2 ± 19.4) (both P < 0.05) lesions. Mean VA change at 12 months was significantly greater for A-T1 (+9.5 letters) compared with T3 (+3.1 letters, P < 0.05). Patients with T3 lesions had fewer active visits (24.9%) than those with other lesion types (T1, 30.5%; T2, 32.6%; A-T1, 27.5%; all P < 0.05). Aflibercept was the most used drug in A-T1 lesions (70.1%) and ranibizumab in T1 (40.7%), T2 (57.7%), and T3 (47.6%) lesions. CONCLUSIONS: This study highlights the relevance of MNV type on clinical outcomes in nAMD and reports significant differences in baseline VA, VA change, and lesion activity at 12 months. This report provides data about lesion-specific clinical features, which may guide the management of nAMD cases and potentially support personalized clinical decision making for these patients. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

CENTRAL BOUQUET HEMORRHAGE: Clinical and Multimodal Imaging Features.

PURPOSE: To describe the clinical characteristics, multimodal imaging features, and anatomic basis of a distinctive pattern of deep retinal hemorrhages located in the central fovea, a presentation referred to as "central bouquet hemorrhage." METHODS: Retrospective, observational, multicenter case series of eyes with central bouquet hemorrhage. Multimodal imaging features were reviewed and analyzed. RESULTS: Ten eyes from 10 patients (4 women and 6 men), with a mean age of 55.6 ± 21.7 years (range 25-84 years) were included. Underlying etiologies were neovascular age-related macular degeneration (40%), lacquer cracks in pathological myopia (30%), macular telangiectasia Type 2 (10%), proliferative diabetic retinopathy (10%), and ocular trauma associated with angioid streaks (10%). On ophthalmoscopy, all eyes with central bouquet hemorrhage displayed a deep retinal hemorrhage with round margins in the central fovea and associated with petaloid hemorrhages radiating in the surrounding Henle fiber layer. Cross-sectional optical coherence tomography showed a well-delineated round hyperreflective lesion involving the central foveal Henle fiber layer/outer nuclear layer in all cases. Accompanying hyperreflective hemorrhages tracking along the obliquely oriented Henle fiber layer were present in all eyes. Resolution occurred in all patients, either spontaneously (30%) or after treatment with intravitreal anti-vascular endothelial growth factor injections (70%), and was associated with partial visual acuity improvement (from 20/113 to 20/36). CONCLUSION: "Central bouquet hemorrhage" is a novel descriptive term describing a characteristic round pattern of intraretinal blood in the fovea associated with Henle fiber layer hemorrhage and encountered in a spectrum of macular disease.

THE EFFECT OF INCREASING ACQUISITION SPEED ON OPTICAL COHERENCE TOMOGRAPHY ANGIOGRAPHY IMAGES: A Qualitative and Quantitative Analysis.

PURPOSE: To evaluate the effect of two different A-scan rates on qualitative and quantitative parameters on optical coherence tomography angiography images in a clinical setting. METHODS: Subjects undergoing a comprehensive ophthalmic examination were scheduled for optical coherence tomography angiography imaging using a new SPECTRALIS device allowing for 85 and 125 kHz scan rate. Consecutive registered 20° × 20° optical coherence tomography angiography images using both speeds were acquired using the follow-up tool. The acquisition time and the quality values of each scan were extracted and analyzed. The image quality was also graded in pairs by two independent graders. RESULTS: Two-hundred and one eyes of 128 consecutive patients (67 males, 52.3%) were included. Mean acquisition time significantly decreased from 56.92 ± 24.6 seconds on the 85 kHz images to 39.39 ± 15.5 seconds on the 125 kHz images (P < 0.001). The percentage change in acquisition time showed a mean decrease of 28.47%. Mean Q value significantly decreased from 32.97 ± 2.8 dB on the 85 kHz images to 31.43 ± 2.6 dB on the 125 kHz images (P < 0.001). Overall, 92.5% of images were graded as equal or better at 125 kHz A-scan rate. CONCLUSION: The use of optical coherence tomography angiography in daily clinical practice may require higher A-scan rates for an optimal workflow. Increased speed may also reduce image sensitivity and thus image quality could be compromised. In this study, 125 kHz scan rate using SPECTRALIS showed significant benefit with reduction on the acquisition time and no clinically significant differences on image quality analysis. Further studies evaluating qualitative and quantitative data in specific retinal conditions and using other devices are required to confirm these results.

Reasons for Delayed Anti-VEGF Treatment During COVID-19 Lockdown and Clinical Impact in Neovascular Age-Related Macular Degeneration.

INTRODUCTION: Timely anti-vascular endothelial growth factor (VEGF) treatment is crucial for visual function in neovascular age-related macular degeneration (nAMD). The aim of this study was to assess the reasons for anti-VEGF treatment delay during the COVID-19 lockdown and its clinical impact in patients with nAMD. METHODS: A retrospective, observational, multicentre study in patients with nAMD treated with anti-VEGF therapy was performed in 16 centres nationwide. Data were retrieved from the FRB Spain registry, patient medical records and administrative databases. Patients were divided into two groups based on whether they received or missed intravitreal injections during the COVID-19 lockdown. RESULTS: A total of 302 eyes from 245 patients were included (timely treated group [TTG] 126 eyes; delayed treatment group [DTG] 176 eyes). Visual acuity (VA; ETDRS letters) decreased from baseline to post-lockdown visit in the DTG (mean [standard deviation] 59.1 (20.8) vs. 57.1 (19.7); p = 0.020) and was maintained in the TTG (64.2 [16.5] vs. 63.6 [17.5]; p = 0.806). VA worsened by an average of - 2.0 letters in the DTG and by - 0.6 in the TTG (p = 0.016). A higher proportion of visits were cancelled due to hospital overload in the TTG (76.5%) than in the DTG (47%), and a higher proportion of patients missed visits in the DTG (53%) than in the TTG (23.5%, p = 0.021), with fear of COVID-19 infection being the main reason for missed visits (60%/50%). CONCLUSIONS: Treatment delays were caused by both hospital saturation and patients' decision; the latter being mainly driven by fear of COVID-19 infection. These delays had a detrimental effect on the visual outcomes in nAMD patients.

Acute macular neuroretinopathy following Moderna COVID-19 vaccination.

PURPOSE: To describe the occurrence of an acute macular neuroretinopathy (AMN) after administration of a Moderna COVID-19 Vaccine. METHODS: Case report. RESULTS: A 23-year-old female presented bilateral visual loss one week after the first dose of COVID-19 vaccine. Fundus examination revealed the classic wedge-shaped lesions with petaloid configuration around both foveas. Hypo-reflective macular lesions are evident in the near-infrared reflectance image. The spectral-domain optical coherence tomography reveled hyperreflectivity of the outer nuclear and plexiform layers, attenuation of the ellipsoid zone and disruption of interdigitation zone corresponding to the lesions. CONCLUSIONS: Despite the large number of doses of COVID-19 vaccines administered worldwide, there are not many reported cases of AMN. Most of them occurred after viral vector vaccines. Described here is one of the few cases that observed a time period of several days after receiving the Moderna messenger RNA vaccine. It is not possible to establish causality although this suggests an inflammatory or autoimmune response to the vaccine.

ADVANTAGES OF OPTICAL COHERENCE TOMOGRAPHY AS A HIGH DYNAMIC RANGE IMAGING MODALITY IN SUBRETINAL HYPERREFLECTIVE MATERIAL.

PURPOSE: To describe the utility of high dynamic range optical coherence tomography imaging to study subretinal hyperreflective material (SHRM) in patients with age-related macular degeneration. METHODS: Clinical information including visual acuity and optical coherence tomography images (Heidelberg Engineering GmbH, Heidelberg, Germany) of patients undergoing antiangiogenic treatment for neovascular age-related macular degeneration and showing SHRM at baseline were retrospectively reviewed. Contrast between strong signal structures (high dynamic range image) reclassifying SHRM as hyperreflective (HyperR), isoreflective, and hyporeflective was increased. The patients at baseline, 3, 6, and 12-months follow-up were evaluated. RESULTS: Forty-four eyes were classified as 15 HyperR (34.1%), 21 as isoreflective (47.7%), and eight as hyporeflective (18.2%). During follow-up, hyporeflective SHRM disappeared in all cases, isoreflective SHRM faded in 16 cases (76.2%); HyperR SHRM remained in all cases. Hyporreflective SHRM showed a greater visual acuity improvement than HyperR SHRM group ( P = 0.033). After 12-month follow-up, only the hyporeflective and isoreflective groups significantly reduced the presence of fluid in 37.5% ( P = 0.250) and 46.62% ( P = 0.006) of the patients, respectively; outer retinal layers were disrupted more frequently in the presence of HyperR SHRM (ellipsoid zone, P = 0.16; external limiting membrane, P = 0.007). CONCLUSION: Contrast-enhanced optical coherence tomography images enabled us to classify SHRM according to its reflectivity, showing groups with different disappearance rates, visual acuity improvement, and outer retinal layer disruption. This easy-to-access tool may be helpful as a prognostic factor in neovascular age-related macular degeneration cases.

Twelve-year follow up of a case of autosomal recessive bestrophinopathy with transient resolution of retinal edema in one eye.

PURPOSE: To report 12-year follow-up of a patient with ARB. CASE REPORT: A 25-year-old man presented with blurred vision in his both eyes (OU). Best-corrected visual acuity (BCVA) was 20/63 Snellen equivalent in the right eye (OD) and 20/32 Snellen equivalent in the left eye. The intraocular pressures and anterior segment examination were unrevealing in OU. Posterior segment examination revealed multiple yellowish flecks and dots in the posterior pole in OU. Optical coherence tomography (OCT) showed subretinal fluid (SRF), intraretinal hyporeflective spaces, elongated and shaggy photoreceptors and outer retinal defects. Fundus autofluorescence demonstrated mottling hyperautofluorescence and hypoautofluorescence in the posterior pole in OU. Fluorescein angiography illustrated hyperfluorescence in the posterior pole and surrounding the arcades in OU. Multifocal electroretinography objectified mild to markedly abnormal responses in all ring areas in OU. Molecular genetic testing confirmed two heterozygous sequence variations in the BEST1 gene. At 4 years of follow-up, OCT revealed a complete resolution of SRF and a partial resolution of intraretinal hyporeflective spaces in the OD with corresponding improvement in the BCVA to 20/23 Snellen equivalent in the OD, even though outer retinal defects persisted. Our patient denied recent changes in his alimentary habits and medical history at that time. Posteriorly, SRF and intraretinal hyporeflective spaces reappeared in the OD. CONCLUSION: To the best of our knowledge, this is the first case report of ARB with a transient resolution of retinal edema in one eye without medical treatment and dietary therapy.

Vitrectomized vs non-vitrectomized eyes in DEX implant treatment for DMO-Is there any difference? the VITDEX study.

OBJECTIVE: We aimed to compare visual and anatomical outcome in vitrectomized and non-vitrectomized eyes treated with dexamethasone (DEX) implant due to diabetic macular oedema (DMO). DESIGN: Multicenter, retrospective, interventional study. PARTICIPANTS: 236 eyes from 234 patients with DMO with or without previous vitrectomy performed with follow-up of 12 months. METHODS: Records were reviewed for cases of DMO treated with DEX implant in vitrectomized and not vitrectomized eyes. Best corrected visual acuity (BCVA), central subfoveal thickness (CST), and intraocular pressure (IOP) were recorded at baseline and 12 months after treatment with DEX implants. Correlations between vitreous status and visual and anatomical outcome, as well as safety profile were analysed. MAIN OUTCOME MEASURES: BCVA and CST over follow-up period. SECONDARY OUTCOMES: cataract rate formation, intraocular pressure increase, number of implants needed. RESULTS: The non-vitrectomized group included 130 eyes (55.1%), the vitrectomized group included 106 eyes (44.9%). The groups were well balanced for age and gender (p = 0.540, and p = 0.053, respectively). Both groups showed statistically significant improvement in BCVA and CST (for all groups: p < 0.001). There was no significant difference between the groups in terms of change in vision (p = 0.89) and anatomy (p = 0.65). The mean number of DEX implants given during follow-up was 3.5 in both groups, and there was no significant difference between the groups (p = 0.81). CONCLUSION: We demonstrated similar anatomical and functional efficacy of DEX implant in non-vitrectomized and vitrectomized eyes. Its efficacy was not influenced by full vitrectomy for diabetic retinopathy complications. Safety profile was well balanced between groups.

Non-arteritic anterior ischemic optic neuropathy after uneventful delivery in a healthy woman.

INTRODUCTION: Non-arteritic anterior ischemic optic neuropathy (NAION) is the most common cause of optic nerve swelling and optic neuropathy in adults over 50 years of age. It has been rarely reported during pregnancy, mostly related to systemic and ocular predisposing conditions. CASE REPORT: We report the case of a 44 years-old healthy female with no previous remarkable clinical history. She had in vitro fertilisation treatment to get pregnant. 18 days after uneventful cesarean section she referred sudden painless vision loss in her right eye (RE), denser inferiorly, with concurrent optic disc edema and relative afferent pupillary defect. Steroid intravenous treatment during the acute episode showed no improvement. Our patient showed normal magnetic resonance imaging (MRI), blood test, autoimmune disease biomarkers, infectious serology and inflammatory markers. She was diagnosed of RE NAION. After one year follow-up visual field defect remains stable. CONCLUSION: As far as we know this is the first report of NAION after in vitro fertilisation, uneventful pregnancy and cesarean section showing no systemic or ocular risk factors other than a small cup to disc ratio. Hemodynamic and hormonal changes during late pregnancy and uneventful cesarean section can trigger an episode of NAION in a healthy young woman.

Use of Artificial Tears in Patients Undergoing Treatment with Anti-VEGF Intravitreal Injections.

Purpose: To analyze the use of artificial tears in patients undergoing treatment with anti-vascular endothelial growth (anti-VEGF) intravitreal injections. Methods: Thirty-four eyes undergoing anti-VEGF treatment were analyzed. Each patient underwent a subjective and objective evaluation of the ocular surface, using the Ocular Surface Disease Index (OSDI), Dry Eye Questionnaire (DEQ)-5, tear meniscus height (TMH), first and average non-invasive Keratograph Break-Up Time (NIKBUT), bulbar conjunctival redness, meibography and the Vision Break-Up Time (VBUT). Patients attended 5 visits (days 0, 7, 30, 37, and 60). All patients continued with their intravitreal injection treatment during the study (days 0, 30, and 60). Patients did not receive any artificial tear treatment during the first month of the study, and at the baseline visit they were randomly assigned to one of two study groups to receive either the Systane Hydration or the Viscofresh 10mg/mL formulation. Patients were instructed to instill one drop of the assigned study treatment 3 times a day for 30 days during the second month of the study. Results: According to the Mixed Models for Repeated Measures analysis, there is not enough statistical evidence for any of the parameters examined to determine significant differences between being treated with artificial tears and not being treated (p > 0.05). There is, however, a tendency toward improved outcomes in some parameters when artificial tears were used. OSDI, DEQ-5, TMH, and meibography were not affected by either the type of artificial tear used or by the time (from day 30 to day 60; p > 0.05), but the NIKBUT and VBUT values increased over time during this period regardless of which treatment the patient was receiving. Conclusion: The use of artificial tears may help to keep the tear film stable Future studies with larger samples should be conducted to elucidate whether the tendency reported in our study becomes significant.

Atypical acute fovealitis in COVID-19 context.

Purpose: To describe the clinical and multimodal imaging findings, including optical coherence tomography (OCT), and OCT angiography (OCTA) in a case presenting with acute fovealitis after COVID-19 infection, and its differential diagnosis. Observations: A 39-year-old man presenting with acute central metamorphopsia in his right eye (OD) right after positive test for COVID-19 underwent comprehensive ophthalmic examination, including best corrected visual acuity (BCVA), color fundus (CF) examination, optical coherence tomography (OCT), OCT angiography (OCTA), fundus autofluorescence (FAF) and fluorescein angiography (FA). Baseline BCVA was 20/40 in his OD and fundus examination showed small inferior juxtafoveal hemorrhages with no other vascular abnormalities or peripheral changes. The OCT B-scans revealed a central focal defect of the ellipsoid and interdigitation zones associated with foveal and perifoveal columnar hyperreflectivities involving the photoreceptor layers, the external limiting membrane and outer nuclear layer up to the outer plexiform layer with preservation of the retinal pigment epithelium-Bruch's membrane complex. Both FAF and FA images were unremarkable. Over three months follow-up, the findings progressively resolved, and BCVA improved to 20/20. Conclusions and importance: The presence of hyperreflective material at the fovea in association with adjacent hemorrhages, the absence of alterations of the retinal pigment epithelium in OCT, OCTA, FAF and FA suggested the diagnosis of acute fovealitis in COVID-19 context. The presence of these findings highlights the importance of detailed ophthalmic evaluation in symptomatic patients with COVID-19 positive test.

Five-year outcomes after intravitreal bevacizumab of treatment-naive eyes with macular edema secondary to CRVO in routine clinical practice: Results of the Pan-American Collaborative Retina Study (PACORES) group.

PURPOSE: The purpose of this study was to report the 5-year outcomes of treatment-naive eyes with cystoid macular edema secondary to central retinal vein occlusion treated with intravitreal bevacizumab in routine clinical practice. METHODS: We conducted multicenter retrospective non-comparative case series of 102 eyes. The main outcome measured was the change in best-corrected visual acuity (BCVA) at 5 years. Secondary outcomes included the number of injections and the change in CMT at 5 years. RESULTS: At 5 years, the mean BCVA improved from 1.22 ± 0.58 (Snellen 20/428) at baseline to 1.00 ± 0.68 logMAR (Snellen 20/200; p < 0.0001). At 5 years, 48 (47%) eyes had a gain of ≥ 3 lines, 41 (40.2%) eyes remained within 3 lines and 13 (12.7%) eyes had a loss of ≥ 3 lines of BCVA. The CMT improved from 740 ± 243 to 322 ± 179 µm (p < 0.0001). At 5 years, 59 (57.8%) eyes had a completely dry SD-OCT. Patients received a total of 10.6 ± 6.1 (range 6-27) injections. Baseline BCVA (p < 0.0001) and the duration of symptoms prior to initial anti-VEGF injection (p = 0.0274) were the only predictive factors for BCVA at 5 years. CONCLUSIONS: After 5 years with an average of 10.6 injections, there was a mean gain of 0.22 logMAR. In addition, more eyes achieved a BCVA of ≥ 20/40, gained ≥ 3 lines and less patients had a BCVA ≤ 20/200. Eyes with a better baseline BCVA and a shorter duration of symptoms were more likely to achieve better BCVA at 5 years.

Burden of disease assessment in patients with neovascular age-related macular degeneration in Spain: Results of the AMD-MANAGE study.

BACKGROUND/AIMS: The present study evaluates the burden of neovascular age-related macular degeneration (nAMD) to Healthcare System and patients, describing the management and treatment effectiveness in routine clinical practice in Spain. METHODS: Observational, non-interventional, cross-sectional, retrospective (24 months), multicentre study including patients who started treatment with licensed vascular endothelial growth factor inhibitors (anti-VEGF) for nAMD with a minimum follow up of 24 months. RESULTS: 126 evaluable patients were included with mean (SD) age of 79.1 (7.5) years. From diagnosis, it took a mean (SD) of 0.5 (0.5) months for the first treatment. Throughout 24 months, mean (SD) number of visits per patient was 16.0 (5.0), 9.4 (4.3) associated intravitreal injection. There were 1186 injection visits, 53.6% of them only with injection and 46.3% with injection and tests. After loading phase, preferred treatment regimens were T&E (46.0%), PRN (44.4%), fixed regimen (4.0%), and others (5.6%). Total number of visits in patients with T&E and PRN were 16.5 (5.7) and 15.5 (4.7), respectively. After complete loading phase, mean (SD) time between two consecutive treatment injections was 2.2 (1.6) months. 27.8% patients underwent a treatment change, being lack of response the most frequent reason to change (43.2%). Mean (SD) best-corrected visual acuity change was 2.1 (15.9) letters at 24 months. CONCLUSION: This study showed an important burden to Healthcare System and patients related to monitoring visits. More efficacious and longer lasting treatments could be useful to increase treatment intervals, thus reducing the burden of patients and caregivers and the use of healthcare resources.

Patient and retina specialists' preferences in neovascular age-related macular degeneration treatment. A discrete choice experiment.

INTRODUCTION AND OBJECTIVE: Neovascular age-related macular degeneration (nAMD) leads to severe and permanent visual impairment, significantly impacting patients' quality of life and functional independence. Although treatment with anti- vascular endothelial growth factor (VEGF) prevents and, in some cases, reverses visual damage, the need for frequent monitoring visits and intravitreal injections represents a significant burden on patients, caregivers and retina specialists. OBJECTIVE: To elicit preferences for nAMD treatment characteristics from the perspectives of patients and retina specialists. METHOD: A discrete choice experiment was conducted. Participants (patients > 50 years with nAMD receiving anti-VEGF drugs for at least 2 years and without previous experience with anti-VEGF and retina specialists working in the Spanish National Healthcare System) were asked to select one of two hypothetical treatments resulting from the combination of five attributes (effects on visual function, effects on retinal fluid, treatment regimen, monitoring frequency, and cost); their levels were identified by reviewing the literature and two focus groups. The relative importance (RI) given to each attribute was estimated using a mixed logit model. The marginal rates of substitution (MRS) were calculated taking cost as the risk attribute. RESULTS: A total of 110 patients (P) [aged 79.0 (SD:7.4) years; 57.3% women; 2.3 (SD:0.7) years with nAMD; 2.1 years (SD:0.1) in treatment] and 66 retina specialists (RS) participated in the study. Participants gave greater RI to improvements in their visual function [60.0% (P); 52.7% (RS)], lower monitoring frequency [20.2% (P); 27.1% (RS)] and reduction in retinal fluid [9.8% (P); 13.0%(RS)]. Patients and retina specialists would agree to an increase in cost by 65.0% and 56.5%, respectively, in exchange for improvements of visual function; and 25.5% and 43.3% on delaying monitoring frequency by one month. CONCLUSIONS: Efficacy of treatment, in terms of visual function improvements, is the main driver for treatment election for both patients and retina specialists. Treatment monitoring requirements are also considered, mainly from the retina specialist's perspective. These results suggest that the use of more efficacious anti-VEGF agents with a longer duration of action may contribute to aligning treatment characteristics with patients/specialists' preferences. A better alignment would facilitate better disease management, fulfilling the unmet needs of patients and retina specialists.

Risk of Posterior Capsular Rupture during Phacoemulsification in Patients with the History of Anti-VEGF Intravitreal Injections: Results from the Pan-American Collaborative Retina Study (PACORES) Group.

PURPOSE: To assess the risk for capsular rupture during routine phacoemulsification in patients with a history of anti-VEGF injections and other possible risk modifiers such as treatment patterns, type of anti-VEGF agent, and experience of the surgeon, among others. METHODS: This study reviewed the medical records of 11,129 patients from 7 different hospitals in 5 countries. The study included 939 patients that underwent routine phacoemulsification and had a history of anti-VEGF therapy. We excluded patients with known risk factors for capsular rupture, as well as patients with a history of other retinal procedures. The study extracted data regarding general demographics, the number of previous injections, type of anti-VEGF agent, details of cataract surgery, and anti-VEGF treatment patterns. RESULTS: Overall prevalence of posterior capsular rupture: 7.45% (95% CI: 5.9-9.32%). The mean number of injections per patient was 3.37 ± 2.8. More than 50% of the patients received their last anti-VEGF injection within three months before cataract surgery. The complication rate during intravitreal injections was 1.07%. In the univariate analysis, the experience of the cataract surgeon (inexperience surgeons; OR: 2.93) and the history of prior anti-VEGF therapy (OR: 1.77) were significant risk indicators for PCR (p < 0.05). However, after controlling for age in the multivariate analysis, the trend did not reach a statistical significance. CONCLUSION: The risk for capsular rupture is higher in patients with a history of intravitreal anti-VEGF injections.