Search

A patient presented with melanocytoma and associated choroidal neovascular membrane with hemorrhage involving the macula. The patient was treated with monthly aflibercept (Eylea) injections with significant improvement of best corrected visual acuity. In this report, we explore the development of a choroidal neovascular membrane (CNVM) formation in a patient with melanocytoma and the effect of intravitreal aflibercept (Eylea) on disease course. Case report study used patient data obtained from examination and imaging. The patient was treated with monthly intravitreal aflibercept injections leading to complete resolution of CNVM and hemorrhage, with significant improvement of best corrected visual acuity. Awareness and proper monitoring for the sequelae of melanocytoma are important for early detection and prevention of visually threatening outcomes. In cases of melanocytoma-associated CNVM formation with large subretinal hemorrhage, intravitreal aflibercept can be an effective tool for inducing CNVM regression and allowing improvement of visual acuity.

Background: AMD (age-related macular degeneration) is the main cause of central vision loss in the population over 60 years old. AMD does not affect peripheral vision and complete blindness does not occur, instead, central vision is affected both for distance and for near. The purpose of this study is to evaluate the neovascular form of AMD treatment and compare ocular and systemic effects after intravitreal injection of aflibercept, respectively after bevacizumab when administered in comparable dosages and regimens. We conducted a retrospective, single-center study from June 2021 to December 2022 and enrolled 20 patients with neovascular AMD who had not received any prior treatment for this condition. We randomly assigned them to two groups of 10: group one received aflibercept and group two received bevacizumab as intravitreal injections under aseptic conditions. We excluded 2 patients who did not meet the criteria and ended up with two groups of 9 patients who received monocular treatment. We gave the patients 3 monthly injections of anti-VEGF agent and followed them up at 1 month, 3 months, and 9 months after the treatment. We assessed their visual acuity, intraocular pressure and OCT appearance at each follow-up visit. The primary outcome was visual acuity. All 18 patients included in the study reported an improvement in visual acuity after the intervention. When comparing the two anti-VEGF agents, data revealed the effect of aflibercept was prompter and more long-lasting. Areas of retinal ischemia appeared in both cases. However, they were observed faster in the case of patients treated with aflibercept. Thus, neovascular AMD is a disease that occurs with age, it can be early detected by OCT and slowed the progression to central blindness with intravitreal treatment. [ABSTRACT FROM AUTHOR]

PurposeTo compare the risk of transient vision loss (TVL) probably attributable to a severe intraocular pressure spike after intravitreal aflibercept application using the novel prefilled syringe (PFS) vs. the established vial system (VS).MethodsDatasets of the intravitreal injection service of the Ludwig Maximilians-University Munich and the Technical University Munich, Germany, were screened for documentation of TVL after intravitreal injection of aflibercept. The observation period included two full months prior to the introduction of the novel PFS and two months afterwards. TVL was defined as loss of perception of hand motion for a duration of >30 s.ResultsOver a period of four months, 1720 intravitreal injections of aflibercept were administered in 672 patients. There were 842 injections with the old VS, and 878 injections using the novel PFS. Using the VS, TVL was noted during two injections (0.24%) in two patients, as compared to 11 cases of TVL (1.25%) in 10 patients with the PFS (p = 0.015). Using the PFS, patients had a 5.3-fold risk of TVL as compared to the VS (OR: 5.33; 95% CI: 1.2–24.1; p = 0.0298).ConclusionThere was a more than five-fold risk of TVL using the novel pre-filled aflibercept syringe as compared to the established vial system. During informed consent, this risk should be discussed.

A patient presented with melanocytoma and associated choroidal neovascular membrane with hemorrhage involving the macula. The patient was treated with monthly aflibercept (Eylea) injections with significant improvement of best corrected visual acuity. In this report, we explore the development of a choroidal neovascular membrane (CNVM) formation in a patient with melanocytoma and the effect of intravitreal aflibercept (Eylea) on disease course. Case report study used patient data obtained from examination and imaging. The patient was treated with monthly intravitreal aflibercept injections leading to complete resolution of CNVM and hemorrhage, with significant improvement of best corrected visual acuity. Awareness and proper monitoring for the sequelae of melanocytoma are important for early detection and prevention of visually threatening outcomes. In cases of melanocytoma-associated CNVM formation with large subretinal hemorrhage, intravitreal aflibercept can be an effective tool for inducing CNVM regression and allowing improvement of visual acuity. [ABSTRACT FROM AUTHOR]

Abstract Background To determine the safety and efficacy of intravitreal sirolimus and adjunct aflibercept in subjects with persistent, exudative age-related macular degeneration despite previous intravitreal anti-vascular endothelial growth factor (VEGF) treatment. Methods This institutional review board approved, registered (NCT02732899), prospective, subject-masked, single center, randomized controlled trial in subjects with persistent, exudative age-related macular degeneration compared alternating monthly intravitreal sirolimus and aflibercept (combination) versus aflibercept monotherapy (control) every 2 months over the course of 36 weeks. The primary measure of efficacy in the study was the mean change in central subfield thickness. Results 20 subjects were enrolled in the study, with 10 subjects assigned to each treatment group. Subjects had an average of 38 previous anti-VEGF injections. Mean central subfield thickness decreased in the combination group by 54.0 μm compared to 0.1 μm in the control group (p = 0.28). Mean visual acuity improved in the combination group by 2.5 ETDRS letters versus 0.8 ETDRS letters in the control group (p = 0.42). There were no serious ocular adverse events in either group; however, there were three serious systemic events in the combination group, including hospitalizations due to pancreatitis, pneumonia, and worsening hypertension. Conclusion There was no statistically significant difference in the mean central subfield thickness change between the combination and control groups. However, intravitreal sirolimus with adjunct aflibercept did appear to have potential anatomical benefits as a treatment for persistent, exudative age-related macular degeneration and requires further investigation with a larger cohort to better understand the potential risks and benefits. Trial registration: ClinicalTrials.gov, NCT02732899. Registered 11 March 2016, https://clinicaltrials.gov/ct2/show/NCT02732899 . This trial was approved by the institutional review board at Advarra. Funding was provided by an investigator-initiated grant from Santen. Santen played no role in the design or implementation of this study.

Background: To determine the safety and efficacy of intravitreal sirolimus and adjunct aflibercept in subjects with persistent, exudative age-related macular degeneration despite previous intravitreal anti-vascular endothelial growth factor (VEGF) treatment. Methods: This institutional review board approved, registered (NCT02732899), prospective, subject-masked, single center, randomized controlled trial in subjects with persistent, exudative age-related macular degeneration compared alternating monthly intravitreal sirolimus and aflibercept (combination) versus aflibercept monotherapy (control) every 2 months over the course of 36 weeks. The primary measure of efficacy in the study was the mean change in central subfield thickness. Results: 20 subjects were enrolled in the study, with 10 subjects assigned to each treatment group. Subjects had an average of 38 previous anti-VEGF injections. Mean central subfield thickness decreased in the combination group by 54.0 μm compared to 0.1 μm in the control group (p = 0.28). Mean visual acuity improved in the combination group by 2.5 ETDRS letters versus 0.8 ETDRS letters in the control group (p = 0.42). There were no serious ocular adverse events in either group; however, there were three serious systemic events in the combination group, including hospitalizations due to pancreatitis, pneumonia, and worsening hypertension. Conclusion: There was no statistically significant difference in the mean central subfield thickness change between the combination and control groups. However, intravitreal sirolimus with adjunct aflibercept did appear to have potential anatomical benefits as a treatment for persistent, exudative age-related macular degeneration and requires further investigation with a larger cohort to better understand the potential risks and benefits. Trial registration: ClinicalTrials.gov, NCT02732899. Registered 11 March 2016, https://clinicaltrials.gov/ct2/show/NCT02732899. This trial was approved by the institutional review board at Advarra. Funding was provided by an investigator-initiated grant from Santen. Santen played no role in the design or implementation of this study. [ABSTRACT FROM AUTHOR]

Retinal disease management has witnessed remarkable advances in posterior segment pharmacotherapy with the development of anti-VEGF molecules such as Lucentis® (ranibizumab), Eylea® (aflibercept), and off-label bevacizumab (Avastin). The US patents for ranibizumab and aflibercept will expire in 2020 (though Regeneron has indicated that it might attempt to extend its US patent to June 2023 with additional patent claims), and their European patents will expire in 2022 and 2025. Aflibercept comes off patent in 2022 in People's Republic of China and Japan. As soon as each patent expires, biosimilar molecules could potentially come in the mainstream clinical practice as a more cost-efficient choice in the form of generic biosimilars. It is difficult to predict how significant this shift would be in terms of more cost-effective clinical management and how it will impact the care in developed and developing world. It is important for clinicians to have a clear understanding about ophthalmic biosimilars before the industry brings these molecules to the mainstream clinical use globally.

Purpose: The aim of this study was to estimate the 1‐year costs associated with treating diabetic macular oedema (DME) patients using current intravitreal anti‐vascular endothelial growth factor (anti‐VEGF) biologics compared with the dexamethasone implant. Methods: We conducted a descriptive cost‐evaluation analysis using data from Oslo University Hospital and literature to compare three different intravitreal drugs for DME: bevacizumab, aflibercept and dexamethasone. Stratification of patients into 'Naive' or 'Switch' group was based on treatment history. We estimated the costs from healthcare and 'extended' healthcare perspectives. Sensitivity analysis evaluated the impact of various parameters. Results: The average injections per patient per year for the Naive group (bevacizumab), Switch group (aflibercept) and dexamethasone were 9.5, 9.1 and 3.0 respectively. From a healthcare perspective, the 1‐year costs for the Naive group were 15% lower (bevacizumab, €3619), and for the Switch group, 23% higher (aflibercept, €5226) compared with dexamethasone (€4252). The 'extended' healthcare perspective showed the cost per patient per year for bevacizumab remained nominally lower in the Naive group, while dexamethasone remained lower for the Switch group (€5116 for dexamethasone, compared to €4987 for bevacizumab and €6537 for aflibercept). Conclusions: From a primary healthcare perspective, the dexamethasone as a first‐line DME treatment may increase economic costs in settings where bevacizumab is used off‐label. Treating resistant DMEwith dexamethasone may reduce the costs and treatment burden compared with switching to aflibercept. [ABSTRACT FROM AUTHOR]

Biosimilars for retinal diseases have been a topic of discussion recently due to the approval of two biosimilar ranibizumab by the US FDA and EMA. It is important to understand this emerging field in retina with many other biosimilar anti-VEGF molecules in the final stage of their trials. Hopefully, they will be available for clinical use very soon. Articles update about the approved biosimilar ranibizumab for retinal diseases and list out ranibizumab and aflibercept biosimilars in the pipeline. Approval of biosimilar anti-VEGFs might be able to drive a geographically variable change in the usage of retinal pharmacotherapy based on the local policies of the health system. [ABSTRACT FROM AUTHOR]

A 72-year-old male treated with aflibercept (Eylea) due to choroidal neovascularization (CNV) in his left eye developed a full-thickness macular hole (MH) after the second injection. The occurrence of MH in his left eye resulted in further visual acuity deterioration. As a consequence of having developed the MH, the patient was operated on. Phacoemulsification and vitrectomy with internal limiting membrane peeling and 20% SF6 tamponade were performed. MH closure was achieved and best corrected visual acuity improved to the extent allowed by CNV. The patient continued anti-VEGF treatment with Eylea due to wet age-related macular degeneration in his left eye. The observation period of 2 years has been uneventful and visual acuity of 0.2 has remained stable.

Ashish Sharma,1 Prahalad Reddy,1 Baruch D Kuppermann,2 Bandello Francesco,3 Anat Lowenstein41Department of Vitreoretina, Lotus Eye Hospital and Institute, Coimbatore, Tamil Nadu, India; 2Department of Ophthalmology, Gavin Herbert Eye Institute, University of California, Irvine, CA, USA; 3Department of Ophthalmology, Scientific Institute San Raffaele, University Vita-Salute, Milano, Italy; 4Division of Ophthalmology, Tel Aviv Sourasky Medical Center, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel Abstract: Retinal disease management has witnessed remarkable advances in posterior segment pharmacotherapy with the development of anti-VEGF molecules such as Lucentis® (ranibizumab), Eylea® (aflibercept), and off-label bevacizumab (Avastin). The US patents for ranibizumab and aflibercept will expire in 2020 (though Regeneron has indicated that it might attempt to extend its US patent to June 2023 with additional patent claims), and their European patents will expire in 2022 and 2025. Aflibercept comes off patent in 2022 in People’s Republic of China and Japan. As soon as each patent expires, biosimilar molecules could potentially come in the mainstream clinical practice as a more cost-efficient choice in the form of generic biosimilars. It is difficult to predict how significant this shift would be in terms of more cost-effective clinical management and how it will impact the care in developed and developing world. It is important for clinicians to have a clear understanding about ophthalmic biosimilars before the industry brings these molecules to the mainstream clinical use globally.Keywords: biosimilar, Razumab®, Lucentis®, Eylea®, ophthalmology

A 72-year-old male treated with aflibercept (Eylea) due to choroidal neovascularization (CNV) in his left eye developed a full-thickness macular hole (MH) after the second injection. The occurrence of MH in his left eye resulted in further visual acuity deterioration. As a consequence of having developed the MH, the patient was operated on. Phacoemulsification and vitrectomy with internal limiting membrane peeling and 20% SF6 tamponade were performed. MH closure was achieved and best corrected visual acuity improved to the extent allowed by CNV. The patient continued anti-VEGF treatment with Eylea due to wet age-related macular degeneration in his left eye. The observation period of 2 years has been uneventful and visual acuity of 0.2 has remained stable. [ABSTRACT FROM AUTHOR]

Background: We present an interesting case of bilateral retinitis pigmentosa (RP)-associated cystoid macular oedema that responded on two separate occasions to intravitreal injections of aflibercept, despite previously demonstrating only minimal response to intravitreal ranibizumab. This unique case would support a trial of intravitreal aflibercept for the treatment of RP-associated cystoid macular oedema. Case Presentation: A 38-year-old man from Dubai, United Arab Emirates, presented to the UK with a 3-year history of bilateral RP-associated cystoid macular oedema. Previous treatment with topical dorzolamide, oral acetazolamide, and intravitreal ranibizumab had demonstrated only minimal reduction of cystoid macular oedema. Following re-confirmation of the diagnosis by clinical examination and optical coherence tomography imaging, bilateral loading doses of intravitreal aflibercept were given. Central macular thickness reduced and the patient returned to Dubai. After 6 months, the patient was treated with intravitreal ranibizumab due to re-accumulation of fluid and the unavailability of aflibercept in Dubai. Only minimal reduction of central macular thickness was observed. Once available in Dubai, intravitreal aflibercept was administered bilaterally with further reduction of central macular thickness observed. Visual acuity remained stable throughout. Conclusions: This is the first case report to demonstrate a reduction of RP-associated CMO following intravitreal aflibercept, despite inadequate response to ranibizumab on two separate occasions. Aflibercept may provide superior action to other anti-VEGF medications due to its intermediate size (115 kDa) and higher binding affinity. This is worthy of further investigation in a large prospective cohort over an extended time to determine the safety and efficacy of intravitreal aflibercept for use in this condition.

Purpose: To compare the risk of transient vision loss (TVL) probably attributable to a severe intraocular pressure spike after intravitreal aflibercept application using the novel prefilled syringe (PFS) vs. the established vial system (VS)., Methods: Datasets of the intravitreal injection service of the Ludwig Maximilians-University Munich and the Technical University Munich, Germany, were screened for documentation of TVL after intravitreal injection of aflibercept. The observation period included two full months prior to the introduction of the novel PFS and two months afterwards. TVL was defined as loss of perception of hand motion for a duration of >30 s., Results: Over a period of four months, 1720 intravitreal injections of aflibercept were administered in 672 patients. There were 842 injections with the old VS, and 878 injections using the novel PFS. Using the VS, TVL was noted during two injections (0.24%) in two patients, as compared to 11 cases of TVL (1.25%) in 10 patients with the PFS ( p  = 0.015). Using the PFS, patients had a 5.3-fold risk of TVL as compared to the VS (OR: 5.33; 95% CI: 1.2-24.1; p  = 0.0298)., Conclusion: There was a more than five-fold risk of TVL using the novel pre-filled aflibercept syringe as compared to the established vial system. During informed consent, this risk should be discussed., Competing Interests: JK received previous speaker honoraria from Novartis Pharma GmbH. BS received previous speaker honoraria and travel expenses from Novartis Pharma GmbH and Topcon Corporation. MM received previous speaker honoraria from Novartis Pharma GmbH, Allergan GmbH, Bayer AG, Heidelberg Engineering GmbH, and Carl Zeiss Meditec AG, and research grants for clinical trials Bayer AG, Novartis Pharma GmbH, and Roche AG. SP received previous speaker honoraria, personal consultation honoraria and travel expenses from Novartis Pharma GmbH, Oertli AG, Bayer AG, Alcon Pharma GmbH and Allergan GmbH. JS received previous speaker honoraria, personal consultations honoraria and travel expenses from Apellis Pharmaceuticals GmbH, Novartis Pharma GmbH, Bayer AG, Roche AG, Carl Zeiss Meditec AG, Oculentis OSD Medical GmbH and Allergan GmbH. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Klaas, Bui, Maierhofer, Schworm, Maier, Priglinger and Siedlecki.)

Background: AMD (age-related macular degeneration) is the main cause of central vision loss in the population over 60 years old. AMD does not affect peripheral vision and complete blindness does not occur, instead, central vision is affected both for distance and for near. The purpose of this study is to evaluate the neovascular form of AMD treatment and compare ocular and systemic effects after intravitreal injection of aflibercept, respectively after bevacizumab when administered in comparable dosages and regimens. We conducted a retrospective, single-center study from June 2021 to December 2022 and enrolled 20 patients with neovascular AMD who had not received any prior treatment for this condition. We randomly assigned them to two groups of 10: group one received aflibercept and group two received bevacizumab as intravitreal injections under aseptic conditions. We excluded 2 patients who did not meet the criteria and ended up with two groups of 9 patients who received monocular treatment. We gave the patients 3 monthly injections of anti-VEGF agent and followed them up at 1 month, 3 months, and 9 months after the treatment. We assessed their visual acuity, intraocular pressure and OCT appearance at each follow-up visit. The primary outcome was visual acuity. All 18 patients included in the study reported an improvement in visual acuity after the intervention. When comparing the two anti-VEGF agents, data revealed the effect of aflibercept was prompter and more long-lasting. Areas of retinal ischemia appeared in both cases. However, they were observed faster in the case of patients treated with aflibercept. Thus, neovascular AMD is a disease that occurs with age, it can be early detected by OCT and slowed the progression to central blindness with intravitreal treatment., Competing Interests: None to declare., (Copyright © 2023, Medical University Publishing House Craiova.)

The introduction of antivascular endothelial growth factor agents such as ranibizumab and aflibercept has revolutionized the management of neovascular age-related macular degeneration. A number of randomized clinical trials have shown that ranibizumab and aflibercept produce similar efficacy and safety outcomes. Most of the switching studies published to date show that efficacy benefits are uncontrolled, retrospective trials with limitations in terms of their selection, monitoring, numbers, and assessment criteria. Based on the published literature to date, we propose arguments for and against switching antivascular endothelial growth factor agents, provide our own perspective on this topic, and suggest a focus for future research. [ABSTRACT FROM AUTHOR]

Koushik Tripathy Department of Vitreoretina and Uvea, ICARE Eye Hospital and Postgraduate Institute, Sector-26, Noida, Uttar Pradesh, IndiaRecently, Ruão et al1 have shown in a study spanning 6 years that only 1 of 6560 (0.015%) eyes undergoing unilateral intravitreal anti-vascular endothelial growth factor (anti-VEGF) injection developed culture-proven endophthalmitis. None of the 1612 eyes receiving immediate sequential bilateral intravitreal treatment (ISBIVT) with anti-VEGF injection developed endophthalmitis.1 Likewise, immediate sequential bilateral cataract surgery (ISBCS)2 has been proposed to provide “potentially decreased wait times for surgery, patient convenience and cost savings for health care payors”, with comparable visual outcomes and complication rates. However, in an Indian scenario, there is need for discussion regarding endophthalmitis following ISBIVT injections.View the original paper by Ruão and colleagues.

Background: Cystoid macular edema (CME) in retinitis pigmentosa (RP) has been managed in several ways as documented in the literature, with little success, though. The aim of our study was to report for the first time in literature the use of aflibercept in a patient with RP and CME. Case presentation: A 52-year-old man presented for blurred vision in his right eye. Best-corrected visual acuity (BCVA) was 3/10 in his right eye and 7/10 in his left eye. Physical examination and appropriate laboratory tests lead to the diagnosis of bilateral RP with CME in the right eye. Retinal thickness in the foveal area of the right eye was 631 µm. The patient was treated with a single intravitreal injection of 0.05 ml/0.5 mg aflibercept. One month later, BCVA of the right eye increased to 4/10, while BCVA of the left eye was unchanged. RT in the right eye decreased to 129 µm. Multifocal electroretinogram response did not improve, yet peaks were better-shaped and no areas of eccentral vision were present. Three and six months after injection, these improvements were maintained. Conclusion: This first-reported case indicates that intravitreal aflibercept injection for addressing CME in RP seems to be an effective treatment. [ABSTRACT FROM AUTHOR]

Age-related macular degeneration is the leading cause of irreversible blindness in developed countries with the neovascular form accounting for the majority of severe vision loss in the disease. The management of wet age-related macular degeneration has improved drastically in the past decade as anti-VEGF agents took its place at the forefront of treatment. As the choice of therapy is based on a number of factors, this review summarizes the pivotal studies that brought these agents to use and compares the different agents currently available. This review also briefly describes the promising new therapies that are in development. [ABSTRACT FROM AUTHOR]

Purpose: To assess the real-world efficacy and safety of aflibercept for the treatment of diabetic macular edema (DME)., Methods: A systematic search was conducted across multiple databases. Articles were included if participants had DME and received aflibercept treatment for a minimum of 52 ± 4 weeks. Primary outcomes included changes in best-corrected visual acuity (BCVA) and central macular thickness (CMT). A risk of bias assessment of studies was completed, pooled estimates were obtained, and a meta-regression was performed. Information on adverse events was collected., Results: The search yielded 2112 articles, of which 30 were included. Aflibercept was more effective than laser photocoagulation functionally (12-month BCVA-weighted mean difference [WMD] = 10.77 letters, P < 0.001; 24 months = 8.12 letters, P < 0.001) and anatomically (12-month CMT WMD = -114.12 μm, P < 0.001; 24 months = -90.4 μm, P = 0.004). Compared to bevacizumab, aflibercept was noninferior at improving BCVA at 12 months (WMD = 1.71 letters, P = 0.34) and 24 months (WMD = 1.58 letters, P = 0.083). One study found that aflibercept was more effective than bevacizumab anatomically at 1 and 2 years ( P < 0.001 at 12 and 24 months). Compared to ranibizumab, aflibercept rendered a greater improvement in BCVA at 1 year (WMD = 1.76 letters, P = 0.001), but not 2 years (WMD = 1.66 letters, P = 0.072). CMT was not significantly different between both therapies at 12 months (WMD = -14.30 μm, P = 0.282) and 24 months ( P = 0.08). One study reported greater functional improvement with aflibercept compared with dexamethasone ( P = 0.004), but inferiority in reducing CMT ( P < 0.001). Meta-regression analysis demonstrated that dosing schedule was found to impact outcomes at 12 and 24 months, while study design and sample size did not impact outcomes at 12 months. There were minimal safety concerns using aflibercept therapy., Conclusions: Aflibercept is a safe and effective therapy option for DME in the clinical setting, performing superiorly to laser photocoagulation. Evidence regarding comparisons with bevacizumab, ranibizumab, and dexamethasone is mixed and limited., Competing Interests: There are no conflicts of interest., (Copyright: © 2022 Journal of Current Ophthalmology.)

Vascular endothelial growth factor (VEGF) plays an important role in the pathophysiology of several sight-threatening retinal disorders such as age-related macular degeneration, diabetic macular edema and proliferative diabetic retinopathy. The discovery of anti-VEGF agents has revolutionized our treatment of these conditions. There are 4 anti-VEGF agents that are either approved or in common use in ophthalmology, namely pegaptanib (Macugen, Pfizer), ranibizumab (Lucentis, Novartis), aflibercept or VEGF Trap-Eye (EYLEA, Bayer) and bevacizumab (Avastin, Roche). There are differences between them. In this review, the differences are discussed in detail. Furthermore, an attempt is made to explain some of the clinical trial data based on their differences in ocular efficacy, duration of action, and local and systemic safety concerns. Copyright © 2012 S. Karger AG, Basel [ABSTRACT FROM AUTHOR]

Purpose: To investigate the effect of posterior vitreous detachment (PVD) on aflibercept response in treatment-naïve diabetic macular oedema (DME)., Design: A retrospective cohort study., Methods: One hundred and fifty eyes of 150 treatment-naïve patients with DME were enrolled. The patients were divided into three groups according to their PVD status: group 1 (no PVD during injections), group 2 (PVD during injections) and group 3 (PVD already present initially). Three consecutive aflibercept injections at intervals of 1 month were applied to all patients. The efficacy of the aflibercept treatment on DME was assessed by comparing changes in central retinal thickness (CRT) and best-corrected visual acuity (BCVA) values after three loading dose injections., Results: After three consecutive injections, the mean reduction of CRT in groups 1, 2 and 3 were -199.6±106.9, -224.9±124.1 and -210.7±126.3, respectively. The decrease in CRT was significant in all groups (p<0.001 in all groups, paired-samples t-test); however, mean changes in CRT were similar among groups (all p>0.05, one-way analysis of variance (ANOVA)). The mean improvement in BCVA in groups 1, 2 and 3 was 6.6±0.9, 6.5±0.8 and 6.1±0.4 ETDRS letters, respectively. The improvement of BCVA was significant in all groups (p<0.001 in all groups, paired-samples t-test) and mean changes were similar between groups (p>0.05, one-way ANOVA). There was no significant relationship between the presence or development of PVD and the mean decrease of CRT and improvement of BCVA (for CRT r=-0.052, p=0.531 and for BCVA r=-0.078, p=0.342)., Conclusion: In the present study, it was observed that the efficacy of aflibercept treatment in patients with DME did not depend on PVD status., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: The pathophysiology of diabetic macular edema (DME) is complex, involving vascular endothelial growth factor (VEGF) and other inflammatory mediators. DME is currently treated first-line with intravitreal anti-VEGF treatments, though some cases are refractory to multiple anti-VEGF treatments., Areas Covered: This article examines the evolution of treatment practices for DME, with discussion of the recent studies that guide treatment for refractory cases of DME. A literature search was performed using the following terms: anti-VEGF, DME, aflibercept, bevacizumab, ranibizumab, refractory macular edema, and VEGF., Expert Opinion: Focal extrafoveal DME may be treated first-line with laser. In patients with center-involving DME and only mild vision loss, consider starting treatment with bevacizumab, especially when cost is an issue, whereas aflibercept may be considered more strongly in patients with moderate visual loss or worse. There are no standard protocols that define 'treatment failure,' but several studies have reported that switching from bevacizumab to either ranibizumab or aflibercept will result in further reduction of CSFT and improvement in BCVA. Further study with prospective randomized trials is warranted to validate these findings. Switching to intravitreal corticosteroids may be of particular benefit to pseudophakic patients. Anti-VEGF combination with sustained-release corticosteroids also appears promising for refractory DME.

Diabetic retinopathy (DR) is the most common cause of visual loss among working age individuals. Diabetic macular edema (DME) is an important complication of DR that affects around one third of the patients with DR. Several treatments have been approved for DME ranging from blood pressure and glycemic control to photocoagulation and more recently the use of vascular endothelial growth factor (VEGF) antagonists. The index review discusses aflibercept (EYLEA(®)-Regeneron Pharmaceuticals, Inc., Tarrytown, New York, NY, and Bayer Healthcare Pharmaceuticals, Berlin, Germany) in the context of other VEGF antagonists currently available for the treatment of DME. A systematic search of literature was conducted on PubMed, Scopus, and Google Scholar with no limitation on language or year of publication. Pre-clinical studies of aflibercept have shown a higher affinity of this molecule for vascular endothelial growth factor A (VEGF-A) along with a longer duration of action as compared to other VEGF antagonists. Recent clinical trials have shown visual outcome results for aflibercept to be similarly favorable as compared to other available agents with the added benefit of fewer required injections and less frequent monitoring. Aflibercept presents a potential exciting new addition to the armamentarium of current VEGF antagonists available for the treatment of DME and other retinal vascular diseases. However, further studies are indicated to confirm the role, safety, and efficacy of aflibercept for DME.