Three-Year Outcomes of Patients with Neovascular Age-Related Macular Degeneration Treated with Aflibercept under the National Health Insurance Program in Taiwan

Purpose. To observe and analyze the long-term outcomes of patients with neovascular age-related macular degeneration (nAMD) treated with aflibercept monotherapy under the National Health Insurance (NHI) program in Taiwan. Methods. This retrospective observational study was conducted at Taipei Veterans General Hospital. Patients with naive nAMD who were treated with aflibercept and followed for more than 3 years were reviewed. The better eye was enrolled if both eyes were affected. Visual acuity (VA) and central macular thickness (CMT) were recorded for 3 years. The lost-to-follow-up rate, number of injections, and predictive factors for visual outcomes were analyzed. Results. Ninety-nine eyes in 99 patients were followed up for 3 years. The mean age at onset of nAMD was 82.8 ± 9.26 years, and 65% of the patients were male. Compared with initial visual acuity, 5 (5.1%) of our patients improved their vision for 3 or more lines after 3 years of follow-up, 11 (11.1%) of our patients improved for 1 to 3 lines, 62 (62.6%) patients remained their vision with 1 line or less changes, 15 (15.2%) patients lost their vision for 1 to 3 lines, and 6 (6%) patients lost their vision for 3 or more lines. The CMT was 359 ± 180 µm before treatment and 259 ± 98 after 3 years (p<0.001). The mean number of injections was 4.63 ± 1.91 in the first year, 2.13 ± 2.2 in the second year, and 1.42 ± 1.79 in the third year. Multivariate analysis showed that final VA was significantly associated with VA at year 1, the presence of retinal pigment epithelial detachment at year 1, and receiving more than four injections in the first year. Final CMT was only significantly associated with CMT at year 1. Conclusion. After 3 years of treatment under the NHI program in Taiwan, 21.2% of the patients with nAMD still had a visual decline despite good anatomical outcomes. More aggressive treatment or other strategies should be used for patients who may have a poor prognosis.

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One-Year Outcomes of 1 Dose versus 3 Loading Doses Followed by Pro Re Nata Regimen Using Ranibizumab for Neovascular Age-Related Macular Degeneration: The ARTIS Trial

Journal of Ophthalmology ◽

10.1155/2019/7530458 ◽

2019 ◽

Vol 2019 ◽

pp. 1-6

Author(s):

Fenghua Wang ◽

Yuanzhi Yuan ◽

Ling Wang ◽

Xiaofeng Ye ◽

Jingke Zhao ◽

...

Keyword(s):

Visual Acuity ◽

Macular Degeneration ◽

Age Related Macular Degeneration ◽

Link Type ◽

Age Related ◽

The Mean ◽

Pro Re Nata ◽

One Year ◽

Number Of Injections

Purpose. To compare the functional and anatomical outcomes of one dose and three loading doses followed by the pro re nata (PRN) regimen in Chinese neovascular age-related macular degeneration (nvAMD) (including polypoidal choroidal vasculopathy (PCV)) patients. Methods. In this multicenter, prospective, open-label, controlled, 12-month study (ClinicalTrials.gov: NCT02810808), patients were randomized (1 : 1) to 1 dose + PRN (PRN group) or 3 loading doses + PRN (LD group) using intravitreal ranibizumab treatment. Best-corrected visual acuity (BCVA) and central retinal thickness (CRT) were evaluated. The main outcome was the change in BCVA. The noninferiority limit was 5 letters. Results. Forty-five patients in the PRN group and 49 patients in the LD group finished 12-month follow-up. Each group included 4 PCV patients. The mean change in BCVA from baseline was 7.8 letters in the PRN group, compared with 10.9 letters in the LD group (P=0.344). There were no significant differences between two groups in the mean change of CRT (−159.3 μm vs. −120.5 μm) at month 12. The mean number of injections during the 12-month follow-up was 6.0 in the PRN group and 6.8 in the LD group. The proportion of patients who gained an improvement in visual acuity by 15 or more letters was 28.9% in the PRN group and 44.9% in the LD group (P=0.066). Conclusion. One dose + PRN showed noninferior visual gains than 3 loading doses + PRN regimen using ranibizumab in Chinese nvAMD and PCV patients. Number of injections in the PRN group was similar as that in the LD group but remained a potential risk of vision instability during one-year follow-up using OCT-guided retreatment criteria. This trial is registered with NCT02810808.

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Effects of Intravitreal Ranibizumab Injection on Chinese Patients with Wet Age-Related Macular Degeneration: 5-Year Follow-Up Results

Journal of Ophthalmology ◽

10.1155/2016/6538192 ◽

2016 ◽

Vol 2016 ◽

pp. 1-5

Author(s):

Yingyi Lu ◽

Jianfeng Huang ◽

Jing Zhao ◽

Xiaobing Yu ◽

Li Long ◽

...

Keyword(s):

Visual Acuity ◽

Macular Degeneration ◽

Age Related Macular Degeneration ◽

Chinese Patients ◽

Intravitreal Ranibizumab ◽

Corrected Visual Acuity ◽

Age Related ◽

The Mean ◽

Number Of Injections

Purpose. To observe the effect of intravitreal ranibizumab injection on wet age-related macular degeneration (wAMD) over 5 years in Chinese patients. Methods. Thirty-seven patients who were diagnosed with wAMD in our hospital from June 2007 to June 2014 were retrospectively reviewed. The PRN regimen and the treatment and extend regimen were applied. Best corrected visual acuity (BCVA), number of ranibizumab injections, and changes in the choroidal neovascularization (CNV) lesion over 5 years were analyzed. Results. The mean BCVA measured by the ETDRS chart at baseline was 47.4 and 5 years after the treatment it was 34.89 letters, which was significantly different (p=0.013). Fourteen eyes (37.8%) had improved visual acuity after 5 years. The number of injections in 5 years was 11.53, and most of the injections were in the first two years. Seventeen (45.9%) cases developed fibrous lesions, and 2 (5.4%) cases had atrophic lesions after 5 years. The fibrosis/atrophy was significantly correlated with the injection numbers (Pearson, r=0.663, and p=0.000). Conclusion. Most of the patients can maintain visual acuity treated by ranibizumab in the first 3 years. After 5 years, some patients can still improve or maintain visual acuity. Fibrous scarring of the lesion is the main reason for a decrease in vision of wAMD patients.

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Limited Treatment Response during Follow-up after Switching to Aflibercept in Neovascular Age-related Macular Degeneration

Journal of the Korean Ophthalmological Society ◽

10.3341/jkos.2021.62.9.1218 ◽

2021 ◽

Vol 62 (9) ◽

pp. 1218-1226

Author(s):

Gon Soo Choe ◽

Jong Woo Kim ◽

Chul Gu Kim ◽

Jae Hui Kim

Keyword(s):

Visual Acuity ◽

Retrospective Study ◽

Macular Degeneration ◽

Treatment Response ◽

Visual Outcome ◽

Age Related Macular Degeneration ◽

Neovascular Amd ◽

Age Related ◽

The Mean

Purpose: To investigate the limited response to aflibercept after switching to aflibercept in neovascular age-related macular degeneration (AMD). Methods: This retrospective study included 70 eyes with neovascular AMD that were initially treated with ranibizumab and then switched to aflibercept. The incidence and timing of the limited response to aflibercept were identified and visual outcome was compared between eyes with and without limited response. In addition, factors predictive of limited response were analyzed. Results: A limited response to aflibercept was noted in approximately 1/5 of the patients who underwent switching to aflibercept in neovascular AMD. Switching to aflibercept was performed at a mean of 16.2 ± 12.7 months after diagnosis. During the mean 34.7 months of follow-up after switching, limited response was noted in 15 eyes (21.4%) at a mean of 22.0 ± 13.9 months after switching. The degree of reduction in visual acuity was mean logMAR 0.34 ± 0.41 in eyes with limited response and mean 0.06 ± 0.20 in eyes without (p = 0.002). In addition, the duration between the diagnosis and the switching was shorter (p = 0.012), and the number of ranibizumab injections before switching was lower (p = 0.016) in eyes with limited response than in eyes without. Conclusions: Patients who showed limited response to aflibercept after switching to aflibercept showed a worse visual outcome. The probability of having a limited response is higher when the switching is performed earlier.

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Aflibercept in real-life for the treatment of age-related macular degeneration using a treat and extend protocol: The Armada study

European Journal of Ophthalmology ◽

10.1177/11206721211005703 ◽

2021 ◽

pp. 112067212110057

Author(s):

Pierre Gascon ◽

Prithvi Ramtohul ◽

Charles Delaporte ◽

Sébastien Kerever ◽

Danièle Denis ◽

...

Keyword(s):

Macular Degeneration ◽

Real Life ◽

Age Related Macular Degeneration ◽

Cumulative Number ◽

Treat And Extend ◽

Treatment Interval ◽

Age Related ◽

Treatment Naïve ◽

The Mean

Purpose: To report the visual and anatomic outcomes in treatment-naïve neovascular age-related macular degeneration (nAMD) patients treated with aflibercept under a standardized Treat and Extend (T&E) protocol for up to 3 years of follow-up in “real-life” practice. Methods: This retrospective, observational, multicenter study included patients with treatment-naïve nAMD and at least 12 months of follow-up. T&E regimen adjustment was initiated after loading phase. At each visit best-corrected visual acuity (BCVA) and optical coherence tomography parameters were performed. Results: One hundred and thirty-six eyes of 115patients had at least 1 year of follow-up with 114 and 82 eyes completing at least 2 and 3 years of follow-up, respectively (mean follow-up duration: 2.7 ± 1.3 years). Mean age was 78.6 ± 8.6 years old and 52% were women. Mean BCVA increased from 60.6 ± 18.7 letters at diagnosis to 66.9 ± 16.2 letters at 1 year (+6.3 letters, p = 0.003) and remained stable throughout the follow-up period (63.1 ± 20.3 letters (+2.5, p = 0.1) and 64.0 ± 20.1 letters (+3.4, p = 0.27) at 2 and 3 years, respectively). The mean central retinal thickness decreased significantly from 358.2 ± 87.9 µm at baseline to 302 ± 71.7 µm at 12 months and maintained stable after 36 months of follow-up (297.1 ± 76 µm, p < 0.0001). Mean number of injections was 6.6 ± 2.2, 4.8 ± 1.9, and 5.6 ± 1.7 at 1, 2, and 3 years, respectively. Mean cumulative number of 16.4 ± 5.6 injections after 3 years. Mean treatment interval was 6.8 ± 2.5 weeks at 1 year. Eight-week and 12-week treatment interval were achieved in 59.5% and 19.1%, 65.8%, and 36.8% and 69.5% and 41.5% at 1, 2, and 3 years, respectively. Conclusions: Our study demonstrated that intravitreal injections of aflibercept initiated under a standardized T&E for patients with treatment-naïve nAMD allow for significant visual improvement at 12 months, which was maintained over a 3-year follow-up period.

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Effect of Ranibizumab Treatment in Cases of Choroidal Neovascular Membranes Secondary to Pathological Myopia versus Age-Related Macular Degeneration

QJM ◽

10.1093/qjmed/hcaa058.011 ◽

2020 ◽

Vol 113 (Supplement_1) ◽

Author(s):

M S Abdaltawab ◽

Z F Ismail ◽

W M A Ebeid ◽

S M Fawzy

Keyword(s):

Visual Acuity ◽

Macular Degeneration ◽

Age Related Macular Degeneration ◽

Intravitreal Injections ◽

P Value ◽

Newly Diagnosed ◽

Pathological Myopia ◽

Age Related ◽

Significant Difference ◽

The Mean

Abstract Aim of the Work The aim of this work is to compare the response of treatment with ranibizumab in terms of visual acuity in cases of CNV secondary to pathological myopia versus CNV secondary to age-related macular degeneration. Methods This prospective, comparative study included ten eyes newly diagnosed as having CNV secondary to pathological myopia, and 10 eyes newly diagnosed as having subfoveal active CNV secondary to AMD. All patients had 3 monthly intravitreal Injections of 0.50 mg (in 0.05 ml of solution) ranibizumab with monthly evaluation of best corrected visual acuity (BCVA) by Landolt C chart, and also calculated in Logarithm of Minimum Angle of Resolution (Log MAR). Results pretreatment there was no significant difference between the two groups as the mean VA (Log Mar) was 1.31 ± 0.2 in AMD group and 1.17 ± 0.3 in MCNV group of P value = 0.431 and also post three IVI of ranibizumab showed no significant difference between the two groups as the mean VA (Log Mar) was 1.22 ± 0.2 for AMD and 1.22 ± 0.5 for MCNV of P value = 0.635. Conclusion there was no significant difference in BCVA between AMD and MCNV groups after three intravitreal injections of ranibizumab.

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Association between Retinal Thickness Variability and Visual Acuity Outcome during Maintenance Therapy Using Intravitreal Anti-Vascular Endothelial Growth Factor Agents for Neovascular Age-Related Macular Degeneration

Journal of Personalized Medicine ◽

10.3390/jpm11101024 ◽

2021 ◽

Vol 11 (10) ◽

pp. 1024

Author(s):

Timothy Y. Y. Lai ◽

Ricky Y. K. Lai

Keyword(s):

Visual Acuity ◽

Retinal Thickness ◽

Age Related Macular Degeneration ◽

Vascular Endothelial ◽

Anti Vegf ◽

Age Related ◽

Thickness Variability ◽

The Mean ◽

Endothelial Growth Factor

Previous studies based on clinical trial data have demonstrated that greater fluctuations in retinal thickness during the course of intravitreal anti-vascular endothelial growth factor (anti-VEGF) therapy for neovascular age-related macular degeneration (nAMD) is associated with poorer visual acuity outcomes. However, it was unclear whether similar findings would be observed in real-world clinical settings. This study aimed to evaluate the association between retinal thickness variability and visual outcomes in eyes receiving anti-VEGF therapy for nAMD using pro re nata treatment regimen. A total of 64 eyes which received intravitreal anti-VEGF therapy (bevacizumab, ranibizumab or aflibercept) for the treatment of nAMD were evaluated. Variability in spectral-domain optical coherence tomography (OCT) central subfield thickness (CST) was calculated from the standard deviation (SD) values of all follow-up visits after three loading doses from month 3 to month 24. Eyes were divided into quartiles based on the OCT CST variability values and the mean best-corrected visual acuity values at 2 years were compared. At baseline, the mean ± SD logMAR visual acuity and CST were 0.59 ± 0.39 and 364 ± 113 µm, respectively. A significant correlation was found between CST variability and visual acuity at 2 years (Spearman’s ρ = 0.54, p < 0.0001), indicating that eyes with lower CST variability had better visual acuity at 2 years. Eyes with the least CST variability were associated with the highest mean visual acuity improvement at 2 years (quartile 1: +9.7 letters, quartile 2: +1.1 letters, quartile 3: −2.5 letters, quartile 4: −9.5 letters; p = 0.018). No significant difference in the number of anti-VEGF injections was found between the four CST variability quartile groups (p = 0.21). These findings showed that eyes undergoing anti-VEGF therapy for nAMD with more stable OCT CST variability during the follow-up period were associated with better visual outcomes. Clinicians should consider adopting treatment strategies to reduce CST variability during the treatment course for nAMD.

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Comparison of the Effectiveness and Prognostic Factors of Intravitreal Ranibizumab between Typical Neovascular Age-Related Macular Degeneration and Polypoidal Choroidal Vasculopathy over 24 Months of Follow-Up

Ophthalmologica ◽

10.1159/000431000 ◽

2015 ◽

Vol 234 (1) ◽

pp. 33-39 ◽

Cited By ~ 9

Author(s):

Wataru Matsumiya ◽

Shigeru Honda ◽

Keiko Otsuka ◽

Akiko Miki ◽

Takayuki Nagai ◽

...

Keyword(s):

Macular Degeneration ◽

Polypoidal Choroidal Vasculopathy ◽

Age Related Macular Degeneration ◽

Morphological Parameters ◽

Intravitreal Ranibizumab ◽

Corrected Visual Acuity ◽

Age Related ◽

The Mean ◽

Choroidal Vasculopathy

Purpose: To compare the response to ranibizumab between patients with typical neovascular age-related macular degeneration (tAMD) and those with polypoidal choroidal vasculopathy (PCV), and to determine the predictors for the outcomes. Methods: Fifty-nine eyes from 59 consecutive patients (tAMD: 27 eyes, PCV: 32 eyes) were treated with three monthly ranibizumab injections followed by as-needed retreatment. Best-corrected visual acuity (BCVA) and morphological parameters were evaluated over 24 months of follow-up. Results: The mean BCVA in tAMD and PCV patients was significantly improved at 3 months (-0.22 and -0.09 logMAR units, respectively). The improvement in BCVA was sustained up to 24 months in tAMD (p = 0.01) but not in PCV patients. The significant predictor for good response to ranibizumab in tAMD patients was the improvement of BCVA at 3 months, whereas that in PCV patients was the anatomical resolution at 3 months. Conclusions: Ranibizumab is an effective therapy for tAMD and PCV over 24 months. The predictors for good outcome might be different between tAMD and PCV.

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An overview of age-related macular degeneration and its management using external beam radiotherapy

Journal of Radiotherapy in Practice ◽

10.1017/s1460396999000023 ◽

1999 ◽

Vol 1 (1) ◽

pp. 3-9

Author(s):

John Newnham

Keyword(s):

Visual Acuity ◽

Macular Degeneration ◽

External Beam Radiotherapy ◽

Age Related Macular Degeneration ◽

Western World ◽

Rapid Progression ◽

External Beam ◽

Age Related ◽

Radiation Induced

This paper aims to provide an overview of age related macular degeneration (ARMD) and its radiotherapy management.ARMD is already the leading cause of adult blindness in the western world. The neovascular form of ARMD is responsible for some 85% of blindness caused by ARMD as a whole. Its aetiology is unknown. The natural course of the disease is rapid progression from onset to disciform scarring and accompanying loss of visual acuity. Laser photocoagulation is only suitable for 10% of patients with neovascular ARMD. Initial studies using low dose fractionated external beam radiotherapy have demonstrated stable visual acuity over the range of 40–93% at short term follow-up. Only transient acute side effects have been observed. No radiation-induced retinopathy or vasculopathy have been observed. Common radiotherapy macula techniques are reviewed, field sizes examined and criteria for a simple macula technique proposed. A subset of patients with rapidly progressing neovascular ARMD may be candidates for rapid treatment starts. Although follow up times have been short, radiotherapy is a promising option for those patients facing imminent blindness due to rapidly progressive neovascular ARMD.

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Four-Year Outcome of Aflibercept Treatment-Naïve Patients for Neovascular Age-Related Macular Degeneration: Evidence from a Clinical Setting

Journal of Ophthalmology ◽

10.1155/2020/7465270 ◽

2020 ◽

Vol 2020 ◽

pp. 1-7

Author(s):

Yanel Gayadine-Harricham ◽

Virginie Rufin ◽

Sandrine Law-Koune ◽

Thi Ha Chau Tran

Keyword(s):

Macular Degeneration ◽

Clinical Setting ◽

Real Life ◽

Case Series ◽

Analysis Data ◽

Age Related Macular Degeneration ◽

Age Related ◽

Treatment Naïve ◽

Number Of Injections

Introduction. The objective of the study is to report 4-year treatment outcome with intravitreal Aflibercept injections for neovascular age-related macular degeneration (nAMD) as first life therapy in real-life. Patients and Methods. This is a prospective, monocenter, observational case series analysis. Data from treatment-naïve patients with nAMD with at least 4 years of follow-up were included in the analysis. Data including age, gender, and visual acuity measured on Early Treatment of Diabetic Retinopathy Study charts (ETDRS) and injection numbers were recorded. Spectral domain optical coherence tomography (SD-OCT) data at baseline, month 3, month 6, month 12, year 2, 3, and 4 were also recorded. Patients were treated with a modified treat and extend (T&E) regimen. Results. Of the 48 eyes with nAMD treated, only 31 eyes were available at the 4-year follow-up. The mean age was 81 ± 8 years. The VA gain was 7.3 ± 12.7 letters at 1 year 6.5 ± 12.5 letters at 2 years, VA gain 5.2 ± 17 letters at 3 years, and 6.2 ± 18.6 letters at 4 years. The reduction of central retinal thickness was 118 ± 187 μm at 4 years. Complete resolution of fluid was obtained in 18/31 eyes. The total number of injections was 5.7 ± 2.0 during the first year, 2.9 ± 2.9 during the second year, 3.5 ± 3.3 during the third year, and 4.0 ± 3.4 during the fourth year. The total number of injections was 16 ± 10.6, ranging from 3 to 52 injections. Ten eyes developed macular atrophy over the 4-year period. Conclusion. The results suggest that good long-term morphological and functional outcome can be achieved using Aflibercept in clinical setting.

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Safety and tolerability of ranibizumab in uni/bilateral neovascular age-related macular degeneration: 12-month TWEYEs study

British Journal of Ophthalmology ◽

10.1136/bjophthalmol-2019-313907 ◽

2019 ◽

Vol 104 (1) ◽

pp. 64-73

Author(s):

Francesco Bandello ◽

Giovanni Staurenghi ◽

Federico Ricci ◽

Edoardo Midena ◽

Francesco Viola ◽

...

Keyword(s):

Visual Acuity ◽

Macular Degeneration ◽

Age Related Macular Degeneration ◽

Open Label ◽

Age Related ◽

Risk Period ◽

The Mean ◽

Low Incidence ◽

To Receive ◽

Systemic Drug

BackgroundTo evaluate the safety and tolerability of ranibizumab 0.5 mg in patients with uni/bilateral neovascular age-related macular degeneration (nAMD) and best-corrected visual acuity (BCVA)<2/10 and/or second eye affected, regardless of BCVA.MethodsIn this 12-month, prospective, multicentre, open-label, single arm, pragmatic interventional study, patients (N=941) aged ≥ 50 years were to receive ranibizumab as per approved label, monthly until maximum stable visual acuity (VA) was achieved (initially, three or more injections may be required). Thereafter, patients were to be monitored monthly for VA and treatment was to be resumed if VA was reduced due to disease activity.ResultsOf the 936 patients treated with ranibizumab at least once during the study, 823/113 were unilaterally/bilaterally (not simultaneously) treated . The mean (SD) number of ranibizumab injections during the study was 5.4 (2.9)/10.6 (5.0) injections in uni/bilaterally treated patients. Three systemic drug-related adverse events (AEs) (all serious, all in unilaterally treated patients) and 18 systemic AE of special interest (AESIs) (11 serious, 16/2 in unilaterally/bilaterally treated patients) occurred during the study. The annual incidence rate (AIR) (events/1000 person-years) for systemic drug-related AEs, considering a 15-day/30-day risk period, 11.0/8.5 for unilaterally treated patients. Considering the same risk period, the AIR (events/1000 person-years) for systemic AESIs for unilaterally treated patients was 22.1/19.9. Considering a 30-day risk period, the AIR (events/1000 treated eye-years) of ocular drug-related AEs was 23 and AESIs was 11.5.ConclusionsThe low incidence of AEs and AESIs demonstrated the good safety and tolerability of ranibizumab in unilaterally/bilaterally treated patients with nAMD in this real-world setting.

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