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

2021 ◽  
Vol 12 ◽  
Author(s):  
Yun Zhang ◽  
Sheng Gao ◽  
Xun Li ◽  
Xi Huang ◽  
Yi Zhang ◽  
...  

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.

2017 ◽  
Vol 102 (7) ◽  
pp. 959-965 ◽  
Author(s):  
Maria Kataja ◽  
Pekko Hujanen ◽  
Heini Huhtala ◽  
Kai Kaarniranta ◽  
Anja Tuulonen ◽  
...  

AimsTo evaluate outcome of anti-vascular endothelial growth factor (VEGF) therapy for the treatment of neovascular age-related macular degeneration (nAMD) in the real-life setting and to compare incidence of ocular serious adverse events (SAE) after injections administered by nurses and physicians.MethodsRetrospective, single-centre study. Medical records of patients receiving anti-VEGF treatment for nAMD between 2008 and 2013 with three-loading-dose regimen were evaluated. Outcome measures were baseline visual acuity (VA), change in VA, number of intravitreal injections, incidence of ocular SAE and patients’ baseline characteristics affecting VA change. In addition, the number of injections per 1000 citizens living in the serving area and per individuals over 65 years old were estimated.Results1349 eyes in 1117 patients received a total of 11 562 intravitreal anti-VEGF injections. Twenty-one per cent of patients received treatment for both eyes. The mean baseline Snellen VA was 0.32. The mean change of VA from baseline was +2, +2 and ±0 Early Treatment Diabetic Retinopathy Study letters and the mean numbers of injections were 5.7, 4.7 and 4.9 at years 1, 2 and 3, respectively. There was a negative correlation between baseline VA and change of VA. Incidence of endophthalmitis was 0.086%. No difference in the incidence of ocular SAE was identified between injections given by nurses or by physicians. The number of intravitreal injections per all citizens was 9 per 1000 inhabitants and 45 per 1000 inhabitants over 65 years.ConclusionThe VA was maintained at the baseline level (±0 letters) with the mean of 15.3 anti-VEGF injections in real-world clinical practice during 3-year follow-up.


2016 ◽  
Vol 235 (4) ◽  
pp. 225-232 ◽  
Author(s):  
Tomoaki Shiba ◽  
Mao Takahashi ◽  
Izumi Yoshida ◽  
Hikari Taniguchi ◽  
Tadashi Matsumoto ◽  
...  

Purpose: The aim of this study was to determine whether multiple intravitreal injections of anti-vascular endothelial growth factor (VEGF) drugs for age-related macular degeneration (AMD) exacerbate systemic arteriosclerosis, using the cardio-ankle vascular index (CAVI) and intima-media thickness (IMT). Methods: We analyzed the data of 45 AMD patients who received intravitreal injections of anti-VEGF drugs (ranibizumab and/or aflibercept) and underwent systemic evaluations at baseline and after treatment. Reevaluation was conducted at ≥12 months from the initial treatment. Results: The total number of intravitreal injections of overall anti-VEGF drugs was significantly correlated with Δserum cystatin C. The cumulative number of aflibercept injections was identified as an independent protective factor for ΔCAVI. An increase in the cumulative number of intravitreal injections of overall anti-VEGF drugs was identified as a protective factor for Δmean IMT. Conclusion: Repeated intravitreal injections of an anti-VEGF drug for AMD may lead to morphological and functional changes in large arteries.


10.36469/9887 ◽  
2014 ◽  
Vol 2 (1) ◽  
pp. 41-52 ◽  
Author(s):  
Tomohiro Iida ◽  
Aya Narimatsu ◽  
Kenji Adachi ◽  
Edward CY Wang

Purpose: To identify outpatient treatment patterns of patients with exudative age-related macular degeneration (AMD) who received approved anti–vascular endothelial growth factor (VEGF) therapy, using real-world data from hospitals in Japan. Methods: A hospital claims database was retrospectively reviewed for patients diagnosed with exudative AMD who were treated with anti-VEGF therapy in the outpatient setting between January 2010 and December 2012. Within a treatment period of at least 12 months, the frequency of anti-VEGF injections and AMD-related visits, and time intervals between AMD-related visits and anti-VEGF injections were captured for patients who had neither cataracts nor glaucoma. “Loading dose regimen” was defined as the first 2 or 3 monthly doses and “PRN maintenance regimen” (where PRN=pro re nata) was defined as the entire period of time after the loading doses had been administered. Results: Claims data were collected from a total of 219 patients from 13 of 126 hospitals: 217 treated with ranibizumab (8 received pegaptanib as well), 2 with aflibercept. Of these, 68 patients were treated for at least 12 months (all with ranibizumab PRN), and 29 had neither cataracts nor glaucoma and were included in the treatment pattern analysis. These 29 patients received a mean of 3.8 injections in the first 12 months and another 2.5 injections in the second 12 months of treatment. The average number of all outpatient visits was 16.1 in the first 12 months and 13.7 in the second 12 months, and an average of 11.6 days elapsed between injections and the previous outpatient monitoring visits using a PRN schedule. Conclusion: In a real-world setting in Japan, anti-VEGF PRN injections are administered less frequently than in clinical trials, and with time between monitoring and re-injection visits. Nonetheless, patients still visit the hospital frequently, which can significantly burden patients, caregivers, and healthcare providers.


PLoS ONE ◽  
2021 ◽  
Vol 16 (6) ◽  
pp. e0252006
Author(s):  
Yongseok Mun ◽  
Kyu Hyung Park ◽  
Sang Jun Park ◽  
Se Joon Woo

Purpose To evaluate the efficacy of intravitreal anti-vascular endothelial growth factor (anti-VEGF) agents for treatment of neovascular age-related macular degeneration (nAMD) in vitrectomized eyes. Methods The medical records were reviewed of nAMD patients treated with anti-VEGF agents who previously underwent pars plana vitrectomy (PPV). PPV was performed with complete posterior vitreous detachment induction. Results A total of 44 eyes from 44 patients were included. The mean central foveal thickness (CFT) was 478.50 ± 156.93 μm at baseline, 414.25 ± 143.55 μm (86.6% of baseline) at 1 month after first injection (P < 0.001), and 386.75 ± 141.45 μm (80.8% of baseline) after monthly multiple injections (2.30 ± 1.07; range, 1–5) (P < 0.001). The mean logarithm of the minimum angle of resolution best-corrected visual acuity visual acuity (BCVA) was 0.85 ± 0.57 at baseline, 0.86 ± 0.63 after the first injection, and 0.84 ± 0.64 after monthly multiple injections. BCVA improved in 39.5% at 1 month after first injection and 45.2% at 1 month after monthly multiple injections. In the subgroup analysis, CFT of eyes with the posterior capsule decreased significantly to 85.8% and 79.8% of baseline values at 1 month after the first injection and after monthly multiple injections, respectively. CFT of eyes without the posterior capsule decreased to 91.6% and 87.4% of baseline values at 1 month after the first injection and after monthly multiple injections, respectively, without statistical significance. Conclusion Monthly injections of Intravitreal anti-VEGF agents induced favorable anatomical improvement and vision maintenance in vitrectomized eyes with nAMD.


2019 ◽  
Vol 45 (1) ◽  
pp. 1
Author(s):  
Tjahjono D Gondhowiardjo

Secara global telah diterima bahwa perkembangan kemampuan ekonomi suatu Negara, berjalan parallel dengan peningkatan usia harapan hidup masyarakat-nya. Saat ini, usia harapan hidup penduduk Indonesia, berkisar antara 69 tahun (pria) dan 72 tahun (wanita). Kondisi demograpik ini secara tidak langsung akan terkait dengan pergeseran distribusi pola penyakit, terutama pergeseran pola penyakit berdasarkan infeksi menjadi pola penyakit/keadaan degeneratif yang terkait dengan gaya hidup. Hal itu dapat terlihat pada edisi ini, yang di-dominasi oleh makalah segment posterior yang terkait dengan peningkatan usia harapan hidup dan degenerasi (age related macular degeneration), atau kondisi yang secara tidak langsung merupakan refleksi gaya hidup (Diabetes Mellitus atau kualitas viskositas darah).  Kondisi tsb memperlihatkan bahwa, walaupun jaringan bolamata bersifat sangat spesifik  dan merupakan suatu kompartemen yang relatif terpisah dengan adanya sawar darah-bolamata, namun tetap terkait dengan berbagai kondisi sistemik; sehingga bolamata dapat menjadi “jendela” kondisi sistemik. Pergeseran pola penyebab kebutaan ke sisi segmen posterior, menuntut peningkatkan peralatan diagnostik digital dan peralatan intervensi yang lebih canggih, seperti foto-koagulasi laser, vitrektomi dan penggunaan berbagai jenis gas, yang tentunya menuntut keterampilan khusus baik bagi operator maupun paramedis-nya; serta pengobatan anti vascular endothelial growth factor (anti VEGF) secara serial yang relatif mahal, sebagaimana ketiga makalah yang ditampilkan.  Pergeseran pola penyakit tsb, secara tidak langsung menuntut kita, baik sebagai insititusi pelayanan ataupun pendidikan, maupun sebagai individu untuk ikut menyesuaikan diri, terutama dalam mengembangkan pola fikir untuk selalu dapat memberikan yang terbaik bagi pasien-pasien kita.  Namun sayangnya, tanpa sadar kita telah membuat dinding-dinding pembatas yang cenderung membatasi upaya pencapaian tujuan;  dan yang relatif dibuat tanpa mempertimbangkan situasi dan kondisi lokal.  Berbagai batasan tsb, baik yang terjadi secara internal, maupun external telah membelenggu kita terhadap kemungkinan menumbuhkan daya inovasi maupun kreativitas untuk pengembangan keilmuan demi kemaslahatan masyarakat.   Pada era jaminan kesehatan saat ini, pengobatan anti VEGF awalnya mendapat pembiayaan, namun kemudian di hentikan karena pembiayaan terhadap upaya pencegahan kebutaan yang dianggap terlalu tinggi. Hal itu terjadi, antara lain karena penolakan terhadap bukti ilmiah yang menyatakan bahwa sekalipun preparat anti VEGF dengan harga yang lebih murah, terdaftar untuk kondisi lain; namun terbukti tidak ada perbedaan effektivitas dibandingkan dengan jenis obat yang spesifik untuk kelainan mata yang lebih mahal. Selain itu, karena pengabaian pernyataan Badan Kesehatan Dunia yang menyatakan bahwa obat tsb termasuk obat essential untuk pencegahan kebutaan.  Penghentian pendanaan itu, merupakan ironi karena di berbagai Negara tetangga dengan pendapatan domestik yang lebih tinggi, justru memperbolehkan penggunaan obat tsb. Di berbagai Negara maju, dasar penentuan prioritas pendanaan pemerintah dibuat berdasarkan kajian biaya penatalaksaan / tindakan langsung, serta kerugian akibat terjadi pengabaian karena hilangnya potensi individu, keluarga dan masyarakat, baik dalam sisi sosial dan ekonomi bagi Negara (health technology assessment / HTA), berjalan lurus dengan besaran nilai prevalensi, dan Year of Lost Life due to Disability (YLD) serta (disability of activity loss / DALY) akibat suatu kondisi / penyakit.  Nilai YLD dan DALY menampilkan besaran kehilangan produktivitas individu, akibat  suatu penyakit dan dampaknya pada besaran biaya kesehatan yang harus ditanggung; data tersebut dibandingkan dengan nilai serupa untuk penyakit/keadaan lain, seperti stroke, gangguan kardio-vaskular, berbagai jenis kanker dll.


2019 ◽  
Vol 104 (8) ◽  
pp. 1085-1088 ◽  
Author(s):  
Avi Ohayon ◽  
Irene De Rosa ◽  
Oudy Semoun ◽  
Camille Jung ◽  
Donato Colantuono ◽  
...  

AimsTo demonstrate and evaluate the morphological changes of multilayered fibrovascular pigment epithelial detachment (PED) to a single anti-vascular endothelial growth factor (VEGF) injection in age-related macular degeneration (AMD).MethodsWe retrospectively analysed the morphological changes of 30 eyes with exudative AMD showing fibrotic multilayered PED, between two consecutive visits. All patients had one anti-VEGF intravitreal injection at the first visit. We quantitatively analysed the different compartments within the PED and their morphological response.ResultsThe mean follow-up time interval between the first and the second visit was 32.46±4.64 days. We defined three optical coherence tomography zones within the PED: a subretinal pigment epithelium inhomogeneous hyporeflective space (layer 1), a hyper-reflective band beneath layer 1 (layer 2), and a hyporeflective space between the Bruch’s membrane and layer 2 (layer 3). The mean height of layer 1 was 142±44.63 and 99.30±39.79 µm at visits 1 and 2, respectively. The mean thickness of layer 2 was 101.42±46.66 and 82.76±35.24 µm at visits 1 and 2, respectively. The mean height of layer 3 was 35.77±32.77 and 5.66±8.68 µm at visits 1 and 2, respectively (p=0.009). The mean height change for layer 1 was statistically significantly higher than for layer 2 (p=0.0002).ConclusionsFibrovascular PED was compartmented into three layers with different reflectivities that morphologically responded differently to a single anti-VEGF injection. Layer 2 had a statistically significantly lower response compared with layer 1, suggesting the hypothesis of a fibrotic component in layer 2.


Author(s):  
Adeyemi Timothy Adewole ◽  
Tunji Sunday Oluleye ◽  
Yewande Olubunmi Babalola ◽  
Oluwole Majekodunmi ◽  
Modupe Ijaduola

Background: Compare the current indications for intravitreal anti-vascular endothelial growth factor (anti-VEGF) therapy, to make recommendations for planning of services. To review the current indications for intravitreal anti-vascular endothelial growth factor (anti-VEGF) therapy, in order to make recommendations for planning of services.Methods: The medical records of 172 patients who had intravitreal anti-vascular endothelial growth factor (anti-VEGF) injections from January 2016 to December 2019 were retrieved. Socio-demographic and clinical data were extracted, analysed, and compared with data from the previously published audit report covering 2010 to 2012.Results: Three hundred and thirty injections were given to 182 eyes in this cohort of patients. The mean age was 61.1±16.3 years (range <1-90 years), with a male to female ratio of 1.1:1. Retinal vein occlusion, 64 (35%) remained the most common indication for anti-VEGF injections in the eyes treated. This was followed by choroidal neovascular membrane/wet age-related macular degeneration which accounted for 42 (23%) as reported previously. However, cases of proliferative diabetic retinopathy/ diabetic maculopathy needing anti-VEGF were noticed to have almost doubled from about 8 (10%) in the previous study to 15 (27%) in the present study. In addition, idiopathic polypoidal choroidal vasculopathy, 18 (10%) ranked above proliferative sickle cell retinopathy in the present study. Retinopathy of prematurity (ROP), neovascular glaucoma, retinal artery macro-aneurysm and myopic choroidal neovascular membrane were the new emerging indications.Conclusion: There is an expanding indication for anti-VEGF in the management of retinal vascular diseases in the health facility and adequate measures should be put in place for early diagnosis and management. Patients should be counselled on the availability of this treatment option.


2021 ◽  
Author(s):  
Setsuko Kawakami ◽  
Yoshihiro Wakabayashi ◽  
Kazuhiko Umazume ◽  
Yoshihiko Usui ◽  
Daisuke Muramatsu ◽  
...  

Abstract Purpose: To study long-term clinical outcomes in patients with submacular hemorrhage (SMH) and/or vitreous hemorrhage (VH) associated with neovascular age-related macular degeneration (nAMD), who received pars plana vitrectomy (PPV) followed by anti-vascular endothelial growth factor (VEGF) therapy.Methods: In this retrospective case series, 25 eyes with SMH and/or VH associated with nAMD were treated by PPV and followed for at least 24 months. When exudative changes were unresolved or recurred after PPV, additional intravitreal anti-VEGF therapy was given. Results:Mean best-corrected visual acuity (BCVA) of all patients improved significantly at 1, 3, 6, 12, 18 and 24 months (P<0.01) post-PPV and at the final visit (P<0.05). Mean BCVA of 13 eyes with anti-VEGF therapy improved significantly at 1 (P<0.05), 3, 6, 12 (P<0.01), 18 and 24 months (P<0.05), while 12 eyes without anti-VEGF therapy improved at 1, 3 and 6 months (P<0.05) only. Average duration from initial PPV to anti-VEGF therapy initiation was 7.54±9.9 months. Five of 13 eyes (38.5%) with anti-VEGF therapy maintained dry macula for more than 1 year after the last injection. Conclusions: In patients with SMH and VH caused by nAMD, administering intravitreal anti-VEGF therapy when exudative changes are unresolved or recur after PPV maintains improved visual acuity long term.


2021 ◽  
Vol 10 (14) ◽  
pp. 3106
Author(s):  
Fumi Gomi ◽  
Reiko Toyoda ◽  
Annabelle Hein Yoon ◽  
Kota Imai

We investigated the factors associated with the discontinuation of anti-vascular endothelial growth factor (VEGF) therapies in patients with neovascular age-related macular degeneration (AMD). Japanese patients with AMD aged ≥50 years, reporting at least one prior injection of an anti-VEGF drug, completed an online survey covering reasons for discontinuation or dissatisfaction with therapy, quality of life (EQ-5D-5L) and patient activation (PAM-13). The respondents were divided into two cohorts: Cohort 1—patients who discontinued anti-VEGF therapy (n = 207); Cohort 2—patients continuing anti-VEGF therapy (n = 65). The most common reason for discontinuing therapy was the “doctor’s decision” in 89.4% (Cohort 1-1). In the other 22 (10.6%) patients in Cohort 1 (Cohort 1-2), reasons included “no deterioration in vision”, “financial burden” and “ineffective treatment”. Patients in Cohort 2 were dissatisfied with “long waiting times” (77%), “financial burden” and “ineffective treatment”. Pain/discomfort posed the greatest impact on quality of life. Only 5% of patients in Cohorts 1-1 and 2 and none in Cohort 1-2 were considered advocates for their own health. In conclusion, most patients who discontinued anti-VEGF therapy did so at their doctor’s decision. Addressing the reasons associated with discontinuation or dissatisfaction with anti-VEGF therapies might help improve their continuation.


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