Management of neovascular age-related macular degeneration: Taiwan expert consensus

Yeung, Ling; Hsieh, Yi‐Ting; Yang, Chang-Hao; Chen, Lee-Jen; Chen, Shih‐Jen; Cheng, Cheng-Kuo; Sheu, Shwu‐Jiuan; Tsai, Ching‐Yao; Wu, Tsung-Tien; Wu, Wei‐Chi; Chen, San-Ni

doi:10.1016/j.jfma.2021.06.012

Cited by 12 publications

(10 citation statements)

References 66 publications

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“…The SHRM resolution was comparable for both brolucizumab and aflibercept treated eyes. Any retinal fluid presence in the eyes suggests sub-optimal disease control [ 23 , 25 , 26 ]. Thus, improvement in retinal fluid resolution in brolucizumab treated eyes demonstrates an effective anti-VEGF therapy for nAMD Indian patients in clinical practice.…”

Section: Discussionmentioning

confidence: 99%

Efficacy and safety of brolucizumab versus aflibercept in patients with neovascular age-related macular degeneration: a randomized trial in Indian patients

et al. 2022

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Background The current standard treatment for neovascular age-related macular degeneration (nAMD) involves intravitreal injections of anti-vascular endothelial growth factor (anti-VEGF) agents. The aim of the present study was to compare the effectiveness and safety of two anti-VEGF drugs: brolucizumab and aflibercept, in treatment-naïve nAMD Indian patients over a period of 48 weeks. Methods A prospective, randomized, single-centre, single-blinded, two-arm comparative study was conducted between March 2021 and February 2022. Of the 114 patients, 56 received intravitreal injections of brolucizumab (6 mg/50 µL) while 58 received aflibercept (2 mg/50 µL). The patients received 03 initial loading doses at 4-week intervals of both the agents and then respective therapies were given as individualized pro re nata (PRN) regimen based on the signs of active macular neovascularization. The functional and anatomical outcomes measured were mean change in best-corrected visual acuity (BCVA, logMAR), central macular thickness (CMT, µm), presence of intraretinal fluid, subretinal fluid or subretinal hyper-reflective material. Furthermore, the average number of additional injections required after the loading doses, the injection-free interval and safety of both the drugs were also assessed. Results Brolucizumab was found to be non-inferior to aflibercept in terms of mean change in BCVA (−0.13 ± 0.21 logMAR vs. −0.10 ± 0.15 logMAR) and reduction in CMT (−112.59 ± 81.23 µm vs. −86.38 ± 71.82 µm). The percentage of eyes with IRF and SHRM was comparable between both the groups while fewer eyes treated with brolucizumab indicated SRF presence than aflibercept after the loading doses. These beneficial effects of brolucizumab were observed with significant (p < 0.0001) lesser number of injections (1.8 ± 1.1 vs. 3.8 ± 1.5) from week 12 to week 48. Moreover, the probability of no injections after the loading doses was significantly higher with brolucizumab compared to aflibercept indicating prolonged injection-free intervals. The average ocular side effects were comparable in the two groups. One adverse event of severe vitritis requiring treatment with oral steroids occurred in Brolucizumab group, while no such event occurred in Aflibercept group. Conclusion The results of the present study suggest non-inferiority of brolucizumab PRN regimen to aflibercept PRN regimen in treatment naïve nAMD Indian patients while achieving longer inter-injection intervals. Trial registration Clinical Trial Registration of India (CTRI/2021/06/034415). Registered 03 March, 2021, http://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=54328&EncHid=&userName =

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Section: Discussionmentioning

confidence: 99%

Efficacy and safety of brolucizumab versus aflibercept in patients with neovascular age-related macular degeneration: a randomized trial in Indian patients

et al. 2022

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“…They recommend injecting between rectus muscles, and monitoring for rare retinal detachment risk, particularly in patients with myopia. 20 Guidelines or guidance documents that were considered as non-evidence-based [22][23][24][25][26][27] for the purposes of this Rapid Review still provided recommendations that were generally consistent with the evidencebased guidelines that were included. The Ministry of Health Singapore suggests using ranibizumab as an alternative to bevacizumab for treating visual impairment due to wet AMD in adults.…”

Section: Conclusion and Implications For Decision-or Policy-makingmentioning

confidence: 99%

“…Two expert consensus papers from Taiwan 23,25 and 1 recommendation paper 27 for a UK expert panel provided recommendations for a T and E approach for using anti-VEGF drugs. The consensus papers 23,25,27 suggested adjusting injection intervals based on monitoring disease activity or visual function after the loading phase, and recommended initiating a loading phase of 3 consecutive monthly anti-VEGF injections. The suggested frequency is consistent with 1 of the included guidelines.…”

Section: Conclusion and Implications For Decision-or Policy-makingmentioning

confidence: 99%

“…Two NICE technology appraisal guidance papers 22,26 recommended the newly approved anti-VEGF drugs, faricimab or brolucizumab, as potions for treating wet AMD in adults with similar situations as bevacizumab and aflibercept only if, the best-corrected visual acuity is between 6/12 and 6/96; there is no permanent structural damage to the central fovea; the lesion size is 12 disc areas or less in greatest linear dimension, there is recent presumed disease progression (for example, blood vessel growth, as shown by fluorescein angiography, or recent visual acuity changes), and the manufacturer provides these drugs according to the commercial arrangement with confidential discount. Two expert consensus papers from Taiwan 23,25 and 1 recommendation paper 27 for a UK expert panel provided recommendations for a treat-and-extend (T and E) approach using anti-VEGF drugs. The consensus papers 23,25,27 recommend initiating a loading phase of 3 consecutive monthly anti-VEGF injections, followed by adjusting the injection intervals based on monitoring disease activity or visual functions.…”

Section: Appendix 1: Selection Of Included Studiesmentioning

confidence: 99%

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Anti-Vascular Endothelial Growth Factor Drugs for Age-Related Macular Degeneration

Hao,

Bailey

2023

cjht

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What Is the Issue? Wet age-related macular degeneration (AMD) is a serious health concern that causes reduced vision-related function, poor overall quality of life, and increased health care resource usage. Anti-vascular endothelial growth factor (VEGF) drugs are the first-line treatment for wet AMD, and they are injected into the eye. These drugs can slow disease progression but are expensive and require trained medical professionals to administer and monitor treatment response. The criteria for initial injection, maintenance, and discontinuation of anti-VEGF drugs in patients with wet AMD remain unclear. What Did We Do? To inform decisions about the appropriate use of anti-VEGF drugs to treat adults with wet AMD, CADTH sought to identify and summarize recommendations about criteria for the diagnosis of wet AMD and best practices for subsequent treatment with anti-VEGF drugs. An information specialist searched the peer-reviewed and grey literature for clinical practice guidelines published since 2018. What Did We Find? Three evidence-based guidelines recommend optical coherence tomography (OCT) to assess patients with suspected wet AMD. The National Institute for Health and Care Excellence (NICE) guidelines then strongly recommend fundus fluorescein angiography only when OCT does not exclude neovascular disease. The evidence-based guidelines recommend anti-VEGF drugs for wet or neovascular AMD in adults, particularly for patients with recent disease progression. One guideline suggests starting anti-VEGF treatment as soon as possible once the diagnosis of wet AMD is made. The NICE guideline suggests that there may not be any clinically significant distinctions in the effectiveness and safety of various anti-VEGF treatments, including aflibercept, bevacizumab, and ranibizumab, indicating a need for an individualized approach when selecting specific anti-VEGF drugs. However, 1 guideline is inconsistent with NICE, as it suggests choosing bevacizumab first. During the maintenance phase of using anti-VEGF drugs, it is important to closely monitor the patient's response and the disease activity and adjust the injection intervals accordingly. Guidelines recommend taking an individualized approach and emphasizing active patient involvement in switching and discontinuing anti-VEGF drugs for adults with wet AMD. Guidelines or guidance documents without a literature search or unclear methods provided generally consistent recommendations with the included evidence-based guidelines. We did not identify any evidence-based guidelines regarding the use of faricimab or brolucizumab. However, NICE published technology appraisals supporting the use of recently approved anti-VEGF drugs (faricimab and brolucizumab) as alternative options for patients who meet similar criteria for treatment with bevacizumab or aflibercept, and under agreed pricing conditions. What Does It Mean? All identified guidelines consistently recommend anti-VEGF drugs for adults with wet active AMD, with some providing guidance on the use of OCT and other ophthalmological assessments to identify criteria for starting and adjusting treatment. These guidelines recommend personalized and patient-centred approaches for selecting, switching, and discontinuing anti-VEGF medications. Cost is also a crucial factor in decision-making, especially for aflibercept, ranibizumab, and recently approved anti-VEGF drugs such as faricimab and brolucizumab. Further research and evidence-based guidelines are necessary to confirm whether newer drugs can be used in similar situations as older drugs.

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“…Choroidal neovascularization (CNV) is the typical pathological feature of neovascular AMD (nAMD), which is controlled by various growth factors, such as vascular endothelial growth factor (VEGF), and typified by an anomalous angiogenic process (Bressler, 2009). Numerous studies have confirmed the efficacy and safety of anti-VEGF therapy, and published guidelines currently recommend anti-VEGF therapy as the first-line treatment for patients with nAMD (23 January 2018;Flaxel et al, 2020;Yeung et al, 2021), including ranibizumab (Lucentis, Genentech Inc.), bevacizumab (Avastin, Genentech Inc.), aflibercept (Eylea, Regeneron Pharmaceuticals, Inc.), conbercept (Lumitin; Chengdu Kanghong, Inc.) and, recently, brolucizumab (Beovu, Novartis, Inc.) (Schmidt-Erfurth et al, 2014;Flaxel et al, 2020).…”

Section: Introductionmentioning

confidence: 99%

Efficacy and Safety of Anti–Vascular Endothelial Growth Factor Monotherapies for Neovascular Age-Related Macular Degeneration: A Mixed Treatment Comparison

Zhang¹,

Gao²,

Li³

et al. 2021

Front. Pharmacol.

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Background: We aimed to evaluate the comparative efficacy and safety of anti–vascular endothelial growth factor (anti-VEGF) monotherapy to identify its utilization and prioritization in patients with neovascular age-related macular degeneration (nAMD).Methods: Eligible studies included randomized controlled trials comparing the recommended anti-VEGF agents (ranibizumab, bevacizumab, aflibercept, brolucizumab, and conbercept) under various therapeutic regimens. Outcomes of interest included the mean change in best-corrected visual acuity (BCVA), serious adverse events, the proportion of patients who gained ≥15 letters or lost <15 letters in BCVA, the mean change in central retinal thickness, and the number of injections within 12 months.Results: Twenty-seven trials including 10,484 participants and eighteen treatments were identified in the network meta-analysis. The aflibercept 2 mg bimonthly, ranibizumab 0.5 mg T&E, and brolucizumab 6 mg q12w/q8w regimens had better visual efficacy. Brolucizumab had absolute superiority in anatomical outcomes and a relative advantage of safety, as well as good performance of aflibercept 2 mg T&E. The proactive regimens had slightly better efficacy but a slightly increased number of injections versus the reactive regimen. Bevacizumab had a statistically non-significant trend toward a lower degree of efficacy and safety.Conclusion: The visual efficacy of four individual anti-VEGF drugs is comparable. Several statistically significant differences were observed considering special anti-VEGF regimens, suggesting that brolucizumab 6 mg q12w/q8w, aflibercept 2 mg bimonthly or T&E, and ranibizumab 0.5 mg T&E are the ideal anti-VEGF regimens for nAMD patients. In the current landscape, based on the premise of equivalent efficacy and safety, the optimal choice of anti-VEGF monotherapies seems mandatory to obtain maximal benefit.

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Management of neovascular age-related macular degeneration: Taiwan expert consensus

Cited by 12 publications

References 66 publications

Efficacy and safety of brolucizumab versus aflibercept in patients with neovascular age-related macular degeneration: a randomized trial in Indian patients

Efficacy and safety of brolucizumab versus aflibercept in patients with neovascular age-related macular degeneration: a randomized trial in Indian patients

Anti-Vascular Endothelial Growth Factor Drugs for Age-Related Macular Degeneration

Efficacy and Safety of Anti–Vascular Endothelial Growth Factor Monotherapies for Neovascular Age-Related Macular Degeneration: A Mixed Treatment Comparison

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