Aflibercept as First-Line Therapy in Patients with Treatment-Naïve Neovascular Age-Related Macular Degeneration: Prospective Case Series Analysis in Real-Life Clinical Practice

2016 ◽  
Vol 236 (1) ◽  
pp. 29-35 ◽  
Author(s):  
Patricia Udaondo ◽  
David Salom ◽  
Salvador García-Delpech ◽  
Ángel Cisneros-Lanuza
Keyword(s):  
Macular Degeneration ◽  
Real Life ◽  
Case Series ◽  
Daily Practice ◽  
Age Related Macular Degeneration ◽  
Intravitreal Injections ◽  
First Line Therapy ◽  
Age Related ◽  
Treatment Naïve ◽  
The Mean

Purpose: To assess the 13-month effectiveness and safety of aflibercept in naïve patients with neovascular age-related macular degeneration (nvAMD) in a real-life clinical setting. Methods: Thirty-two treatment-naïve patients with nvAMD participated in a prospective two-center study. Patients received intravitreal injections of aflibercept (Eylea®), a loading dose of three monthly injections (2 mg/0.05 ml) every 4 weeks for the first 3 months, followed by intravitreal injections every 2 months. Results: At 3 and 13 months, the mean best-corrected visual acuity improved significantly as compared with baseline (logMAR 0.53 ± 0.30 and 0.55 ± 0.32 vs. 0.30 ± 0.24, respectively, p < 0.001). At 3 and 13 months, 46.8% of patients (15/32) gained ≥15 ETDRS letters. The mean decrease in central macular thickness was also significant at 3 months (252 ± 35 µm) and at 13 months (249 ± 38 µm) as compared with pretreatment values (383 ± 76 µm) (p < 0.01). Also, 50% resolution of pigment epithelial detachment (PED) was observed in 8 out of 9 eyes (88.9%) with PED at baseline. Intravitreal injections were well tolerated and no adverse events were recorded. Conclusion: Aflibercept was effective and safe for treating nvAMD in naïve patients in routine daily practice.

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

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.

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

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.

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

QJM ◽  
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.

scholarly journals Effect of intravitreal injection of aflibercept on blood coagulation parameters in patients with age-related macular degeneration

2020 ◽  
Vol 12 ◽  
pp. 251584142090392
Author(s):  
Constantinos D. Georgakopoulos ◽  
Olga E. Makri ◽  
Athina Pallikari ◽  
Konstantinos Kagkelaris ◽  
Panagiotis Plotas ◽  
...  
Keyword(s):  
Macular Degeneration ◽  
Blood Coagulation ◽  
Intravitreal Injection ◽  
Age Related Macular Degeneration ◽  
Intravitreal Injections ◽  
Clinical Effects ◽  
Coagulation Parameters ◽  
Age Related ◽  
Increased Risk ◽  
Treatment Naïve

Purpose: Treatment with intravitreal injections of anti-vascular endothelial growth factor agents has been associated with an increased risk of arterial thromboembolic events. The aim of the present pilot study was to assess the effect of a single intravitreal injection of aflibercept on coagulation. Methods: Treatment-naïve patients with age-related macular degeneration ( n = 47), who were scheduled to undergo treatment with intravitreal injections of aflibercept, were enrolled. None of the included patients received any anticoagulation therapy or had a history of a recent arterial thromboembolic event. Blood samples were collected before the first intravitreal injection, and at 7 and 30 days after aflibercept administration. We evaluated coagulation parameters, such as platelet count and plasma fibrinogen and D-dimer levels; functional clotting parameters, such as prothrombin time, international normalized ratio, and activated partial thromboplastin time; and anticoagulant parameters, such as the levels of Proteins S and C. Results: The levels of all of the evaluated biomarkers were within the normal range at baseline and at both the time points throughout the study. No statistically significant changes were observed in any of the measured parameters at 1 week and 1 month after aflibercept administration. Conclusion: A single intravitreal injection of aflibercept in treatment-naïve patients with exudative age-related macular degeneration has no statistically significant effect on blood coagulation parameters for up to 1 month after aflibercept administration. Our results also provide an explorative statistical data, and further studies are required to evaluate any significant clinical effects of aflibercept on blood coagulation parameters. ClinicalTrials.gov ID: NCT03509623.

scholarly journals Two-year outcomes of intravitreal aflibercept in a Swiss routine treat and extend regimen for patients with neovascular age-related macular degeneration

2020 ◽  
Vol 10 (1) ◽  
Author(s):  
Andreas Ebneter ◽  
Stephan Michels ◽  
Christian Pruente ◽  
Pascal Imesch ◽  
Felix Eilenberger ◽  
...  
Keyword(s):  
Real Life ◽  
Age Related Macular Degeneration ◽  
Routine Practice ◽  
Treat And Extend ◽  
Treatment Interval ◽  
Age Related ◽  
Intravitreal Aflibercept ◽  
Treatment Naïve ◽  
The Mean ◽  
Treat And Extend Regimen

AbstractThe aim of this observational study was to assess the use and outcome of intravitreal aflibercept in a treat and extend regimen in treatment-naïve neovascular AMD patients in routine practice. This both retrospective and prospective study was conducted in four larger Swiss retina clinics (ASTERIA study). The primary endpoint was the mean change in best-corrected visual acuity (BCVA) in ETDRS letters from baseline to 12 months. Between December 2017 and August 2018, 160 patients were included. For patients with available data, the mean change in BCVA was + 8.4 (± 14.4) letters at month 12 (n = 139) and + 5.0 (± 11.4) letters at month 24 (n = 95). A mean number of 8.3 (± 2.4) injections were administered within the first year and 5.4 (± 2.9) injections during the second year. On average, the observed treatment interval at month 12 was 63.3 (± 22.0) days and increased to 69.1 (± 28.6) days at month 24. For 37% of the patients, a treatment interval ≥ 12 weeks was attained at month 24. In conclusion,  intravitreal aflibercept in a Swiss real-life treat and extend regimen resulted in comparable anatomic and functional outcomes as were observed in the prospective registration trials of aflibercept for nAMD treatment.

Subfoveal choroidal thickness as a prognostic factor in exudative age-related macular degeneration

2018 ◽  
Vol 103 (7) ◽  
pp. 918-921 ◽  
Author(s):  
Jaya B Kumar ◽  
Karen M Wai ◽  
Justin P Ehlers ◽  
Rishi P Singh ◽  
Aleksandra V Rachitskaya
Keyword(s):  
Prognostic Factor ◽  
Macular Degeneration ◽  
Choroidal Thickness ◽  
Age Related Macular Degeneration ◽  
Intravitreal Injections ◽  
Imaging Biomarkers ◽  
Exudative Amd ◽  
Subfoveal Choroidal Thickness ◽  
Age Related ◽  
The Mean

AimsTo investigate the relationship between subfoveal choroidal thickness (SFCT), visual acuity (VA), optical coherence tomography (OCT) features and total anti-vascular endothelial growth factor (VEGF) treatments to determine whether SFCT serves as a prognostic factor in age-related macular degeneration (AMD).MethodsThis is a retrospective case series of 62 consecutive treatment-naive patients with exudative AMD followed for 1 year and treated with treat-and-extend or pro re nata anti-VEGF protocols. SFCT was measured at three locations using Cirrus HD-OCT (the foveal centre and 500 um nasal and temporal to the fovea) at presentation, 3, 6 and 12 months. Demographic characteristics, OCT imaging biomarkers and VA were recorded.ResultsMean SFCT at baseline was 187 µm (range: 70–361 µm). There was a trend of decreasing SFCT at 1 year (173 µm) compared with 3 months (175 µm) and baseline (188 µm) (p=0.2). There was no correlation between baseline SFCT and presence of subretinal fluid (p=0.2), intraretinal fluid (p=0.6) or subretinal hyper-reflective material (p=0.4) at baseline. The mean number of injections at 1 year was 6.6 (range: 2–12). Increased SFCT at baseline showed statistically significant correlation with a higher number of intravitreal injections at 1 year (p=0.004). Eyes with SFCT>1 SD above the mean required 50% more injections compared with others. There was no association between SFCT on presentation with baseline and 1 year VA (p=0.7 and p=0.2).ConclusionsSFCT in naïve patients with exudative AMD may be an important prognostic tool in determining treatment burden. Patients with thicker subfoveal choroid may require increased intravitreal injections.

Trainee-led versus specialist-led management of neovascular age-related macular degeneration: a registry-based study

2018 ◽  
Vol 103 (8) ◽  
pp. 1158-1162
Author(s):  
Rohan W Essex ◽  
Vuong Nguyen ◽  
Vincent Daien ◽  
Sarah Steinmann ◽  
Richard Walton ◽  
...  
Keyword(s):  
Macular Degeneration ◽  
Primary Outcome ◽  
Models Of Care ◽  
Age Related Macular Degeneration ◽  
Outcomes Measures ◽  
Age Related ◽  
Treatment Naïve ◽  
Reasonable Approach ◽  
The Mean

ObjectiveTo compare the outcomes of trainee-led and specialist-led management of neovascular age-related macular degeneration.DesignProspective multicentre registry-based observational study.SettingOphthalmology training centres in Australia and Europe where both trainee-led and specialist-led models of care coexist.ParticipantsTreatment-naïve eyes with neovascular age-related macular degeneration and at least 12 months follow-up. 726 eyes were included in the study from two centres, 534 receiving trainee-led treatment and 192 specialist-led treatment.InterventionsThe management and outcomes of patients receiving trainee-led care were compared with those receiving specialist-led care.Main outcomes measuresThe primary outcome was the mean change in visual acuity at 12 months from first injection. Outcomes were also presented at 36 months where available.ResultsThe mean age of participants was 79 years and 65% were female. The adjusted change in acuity at 12 months in trainee-led vs specialist-led eyes was +3.2 letters vs +4.1 letters (difference −0.9 letters, 95% CI −3.4 to 1.5, p=0.473). The mean adjusted change in acuity at 36 months was −0.9 letters in trainees vs +0.2 letters for specialists (difference −1.1 letters, 95% CI −5.1 to 2.9, p=0.596). Eyes treated by trainees received fewer injections on average to 36 months (15.0 vs 19.0, p=0.004), although this trend was observed at one centre only.ConclusionsNo significant differences in outcome between eyes managed by trainees and eyes managed by specialists were observed. Appropriately structured trainee-led management of neovascular age-related macular degeneration is a reasonable approach where regulatory and practical considerations allow it.

scholarly journals Tolerating subretinal fluid in the treatment of neovascular age-related macular degeneration with intravitreal aflibercept

2021 ◽  
Vol 13 ◽  
pp. 251584142110228
Author(s):  
Dilan Yildiz ◽  
Akin Cakir ◽  
Burak Erden ◽  
Selim Bolukbasi ◽  
Serkan Erdenöz ◽  
...  
Keyword(s):  
Macular Degeneration ◽  
Subretinal Fluid ◽  
Age Related Macular Degeneration ◽  
Age Related ◽  
Intensive Treatment Group ◽  
Significant Difference ◽  
Intravitreal Aflibercept ◽  
Treatment Naïve ◽  
Change In The Mean ◽  
The Mean

Objective: To compare the anatomical and functional outcomes of intensive and relaxed intravitreal aflibercept regimen in the management of neovascular age-related macular degeneration. Methods: The medical records of 50 eyes of 50 patients with treatment-naive neovascular age-related macular degeneration, who underwent intravitreal aflibercept therapy in the Retinal Department of University of Health Sciences Okmeydanı Training and Research Hospital (Istanbul, Turkey), were retrospectively reviewed. The demographic features and best-corrected visual acuities at baseline and at 1st-, 2nd-, 3rd-, 4th-, 6th-, 10th- and 12th- months, optical coherence tomography measurements, presence of intraretinal fluid, subretinal fluid and intraocular pressure values were studied. The patients were divided into two groups: intensive (subretinal fluid intolerant) and relaxed (<200 microns subretinal fluid tolerated) intravitreal aflibercept regimens. Results: The change in the mean best-corrected visual acuities from baseline to 12th month was 13.72 ± 33.97 letters in the intensive treatment group and 8.68 ± 27.22 in the relaxed group. There was no statistically significant difference between the groups ( p = 0.566). Similar proportions of both groups achieved ⩾10 letters gain (%48 vs. %40, respectively; p = 0.755) and ⩾10 letters loss (%20 vs. %24, respectively; p = 0.755). The mean central subfield thickness values decreased statistically significantly in both groups ( p < 0.001). There was no statistically significant difference between the groups (442.40 ± 161.32 to 318.0 ± 63.10 vs. 431.64 ± 151.52 to 303.08 ± 140.91, respectively; p = 0.724). The mean total injection numbers were significantly lower in the relaxed group (6.4 ± 1.65 vs. 4.8 ± 1.45, respectively; p = 0.01). Conclusion: Relaxed intravitreal aflibercept regimen has comparable efficiency and safety outcomes at 12 months with intensive intravitreal aflibercept regimen with fewer injections in the management of neovascular age-related macular degeneration.

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