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 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.

scholarly journals Aflibercept for age-related macular degeneration: 4-year outcomes of a ‘treat-and-extend’ regimen with exit-strategy

2020 ◽  
pp. bjophthalmol-2020-316514
Author(s):  
Damian Jaggi ◽  
Thanoosha Nagamany ◽  
Andreas Ebneter ◽  
Marion Munk ◽  
Sebastian Wolf ◽  
...  
Keyword(s):  
Macular Degeneration ◽  
Age Related Macular Degeneration ◽  
Long Term Outcomes ◽  
Treat And Extend ◽  
Age Related ◽  
Central Subfield Thickness ◽  
Treatment Naïve ◽  
Treat And Extend Regimen

AimTo report long-term outcomes on best-corrected visual acuity (BCVA) and treatment intervals with a treat-and-extend (T&E) regimen in patients with neovascular age-related macular degeneration (nAMD).MethodsThis observational study included treatment-naïve patients with nAMD, treated with aflibercept. A specific T&E protocol without a loading phase and predefined exit criteria was administered. After reaching predefined ‘exit-criteria’, the treatment period was complete, and patients were observed three monthly.ResultsEighty-two patients with a follow-up period of ≥2 years were included. BCVA (mean±SD, ETDRS letters) increased from 51.9±25.2 at baseline to 63.7±17.7 (p<0.0001) at 1 year, 61.7±18.5 (p<0.0001) at 2 years, 62.4±19.5 (p<0.0001, n=61) at 3 years and remained insignificantly higher than baseline at 4 years at 58.5±24.3 (p=0.22). Central subfield thickness (mean±SD, μm) decreased significantly from 387.5±107.6 (p<0.0001) at baseline to 291.9±65.5 (p<0.0001) at 1 year, and remained significantly lower until 4 years at 289.0±59.4 (p<0.0001). Treatment intervals (mean±SD, weeks) could be extended up to 9.3±3.1 weeks at 1 year and remained at 11.2±3.5 weeks at 4 years. Twenty-nine (35%) patients reached exit criteria and continued with three monthly observation only.ConclusionsAfter 4 years of treatment, initial vision gains were maintained with a reasonable treatment burden, even without an initial loading phase. Our results on functional outcomes are comparable with large controlled studies.

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.

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.

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.

scholarly journals Real-World Experience with Brolucizumab in Wet Age-Related Macular Degeneration: The REBA Study

2021 ◽  
Vol 10 (13) ◽  
pp. 2758
Author(s):  
Alper Bilgic ◽  
Laurent Kodjikian ◽  
Francesc March de Ribot ◽  
Vaishali Vasavada ◽  
Jesus H. Gonzalez-Cortes ◽  
...  
Keyword(s):  
Macular Degeneration ◽  
Real World ◽  
Age Related Macular Degeneration ◽  
Secondary Outcome ◽  
The Real ◽  
Switch Therapy ◽  
Age Related ◽  
Treatment Naïve ◽  
The Mean

The aim of the present study was to determine the efficacy and safety of intravitreal brolucizumab therapy for neovascular age-related macular degeneration (AMD) in the real-world setting. The REBA study (real-world experience with brolucizumab in wet AMD) was a retrospective, observational, multicentric study that included 78 consecutive patients (105 eyes), with neovascular AMD, who received brolucizumab therapy. Both treatment-naive and switch-therapy patients were included. Switch therapy was based either on fluid recurrence, fluid recalcitrance, or inability to extend beyond q4/q6. All relevant data were collected. The primary outcome measure was change in best-corrected visual acuity (BCVA) over time. Secondary outcome measures included determination of change in central subfield thickness (CST) and complications. The mean baseline BCVA was 49.4 ± 5.4 letters and 40 ± 3.2 letters, and corresponding mean BCVA gain was +11.9 ± 3.9 letters (p = 0.011) and +10.4 ± 4.8 letters (p = 0.014) in the treatment-naive and switch-therapy groups, respectively. The change in CST was significantly decreased in the treatment-naive (p = 0.021) and the switch-therapy (p = 0.013) groups. The mean follow-up was 10.4 months in both groups. One patient in the switch-therapy group developed vascular occlusion and another a macular hole after the fifth brolucizumab injection. Both patients recovered uneventfully. In conclusion, patients showed a very good anatomical and functional response to brolucizumab therapy in the real world, regardless of prior treatment status, until the end of the follow-up period. Two significant untoward events were noted.

Intravitreal Ranibizumab in Daily Clinical Practice for Age-Related Macular Degeneration: Treatment of Exudative Age-Related Macular Degeneration in Real Life

2015 ◽  
Vol 234 (1) ◽  
pp. 26-32 ◽  
Author(s):  
Agathe Cazet-Supervielle ◽  
Julien Gozlan ◽  
Séverin Cabasson ◽  
Michèle Boissonnot ◽  
Hélène Manic ◽  
...  
Keyword(s):  
Macular Degeneration ◽  
Real Life ◽  
Age Related Macular Degeneration ◽  
Diagnosis And Treatment ◽  
Optic Coherence Tomography ◽  
Intravitreal Ranibizumab ◽  
Age Related ◽  
The Mean ◽  
Practice Methods

Purpose: To describe the anatomical and functional outcomes in patients with exudative age-related macular degeneration (AMD) undergoing ranibizumab therapy in real-life practice. Methods: This is a retrospective analysis of patients with exudative AMD treated with ranibizumab. Visual acuity (VA) and optic coherence tomography characteristics at baseline and at the end of the follow-up, clinical forms of the disease, delay between diagnosis and treatment as well as the number of follow-up visits and of intravitreal injections were collected. Results: One hundred and seventy-nine patients (220 eyes) were followed up during a mean of 24 months. The mean delay between diagnosis and treatment was 20.3 days (SD ±16.8). VA stabilization was observed in 46.4% of eyes, 21.7% of eyes gained ≥15 ETDRS (Early Treatment Diabetic Retinopathy Study) letters and 31.9% lost ≥15 ETDRS letters. The mean central retinal thickness decreased from 380.6 μm at baseline to 295.6 µm at the final examination. A lower baseline VA score was associated with a greater gain of letters (OR 1.04, 95% CI 1.02-1.06; p < 0.001). Conclusion: Shortening the delays in diagnosis appears to be a key point in real-life situations.

scholarly journals Response to Aflibercept Therapy in Three Types of Choroidal Neovascular Membrane in Neovascular Age-Related Macular Degeneration: Real-Life Evidence in the Czech Republic

2019 ◽  
Vol 2019 ◽  
pp. 1-6 ◽  
Author(s):  
Jan Nemcansky ◽  
Alexandr Stepanov ◽  
Michal Koubek ◽  
Miroslav Veith ◽  
Yun Min Klimesova ◽  
...  
Keyword(s):  
Macular Degeneration ◽  
Real Life ◽  
Age Related Macular Degeneration ◽  
Choroidal Neovascular Membrane ◽  
Age Related ◽  
Case Series Study ◽  
Treatment Naïve

Purpose. To present a cohort of treatment-naive patients with the neovascular form of age-related macular degeneration (nAMD) treated with aflibercept in a fixed regimen and evaluate the treatment response of three types of choroidal neovascular membrane (CNV)—occult (Type 1), classic (Type 2), and minimally classic (Type 4). Methods. This was a multicentre, prospective, observational consecutive case series study. Patients diagnosed with three types of CNV of nAMD were treated in a fixed regimen (3 injections every 4 weeks, and then injections at 8 week intervals). The follow-up period was 48 weeks. Best-corrected visual acuity (BCVA) and central retinal thickness (CRT) were measured using Early Treatment Diabetic Retinopathy Study (ETDRS) charts and spectral-domain optical coherence tomography (OCT). The measurements were taken at the baseline and then at 16, 32, and 48 weeks. Results. The treatment-naive group was composed of 135 eyes of 135 patients in the study. 61 eyes had Type 1 lesions of CNV, 50 eyes had Type 2 lesions, and 24 eyes had Type 4 lesions. Mean baseline BCVA ± SD for Type 1 lesions was 56.1 ± 10.8 ETDRS letters, and then 62.2 ± 12.9 letters, 61.2 ± 13.7 letters, and 62.8 ± 15.1 letters at 16, 32, and 48 weeks, respectively. Mean baseline CRT ± SD for Type 1 lesions was 442.4 ± 194.9 μm, and then 302.5 ± 144.4 μm, 299.7 ± 128.5 μm, and 277.7 ± 106.5 μm at 16, 32, and 48 weeks, respectively. Mean baseline BCVA ± SD for Type 2 lesions was 55.6 ± 9.9 ETDRS letters, and then 62.5 ± 11.1 letters, 60.7 ± 13.0 letters, and 62.5 ± 14.2 letters at 16, 32, and 48 weeks, respectively. Mean baseline CRT ± SD. For Type 4 lesions mean baseline BCVA ± SD was 56.7 ± 9.0 ETDRS letters, and then 59.1 ± 10.6 letters, 59.5 ± 11.4 letters, and 59.2 ± 12.6 letters at 16, 32, and 48 weeks respectively. Mean baseline CRT ± SD for Type 4 lesions was 492.1 ± 187.0 μm, and then 333.3 ± 137.5 μm, 354.4 ± 175.0 μm, and 326.7 ± 122.4 μm at 16, 32, and 48 weeks respectively. All these changes were statistically significant (p<0.005). Conclusions. The primary outcome of our study is that the treatment with aflibercept in nAMD patients led to statistically significant improvement in BCVA and to a decrease in CRT throughout the follow-up period in both occult and classic types of CNV. The minimally classic type of CNV demonstrated a poorer functional and anatomical response to treatment.

Four-year outcomes of aflibercept treatment for neovascular age-related macular degeneration: Results from real-life setting

2020 ◽  
pp. 112067212093856
Author(s):  
Marko Lukic ◽  
Maria Eleftheriadou ◽  
Robin D Hamilton ◽  
Ranjan Rajendram ◽  
Kajo Bucan ◽  
...  
Keyword(s):  
Macular Degeneration ◽  
Cohort Analysis ◽  
Real Life ◽  
Epidemiological Data ◽  
Age Related Macular Degeneration ◽  
Age Related ◽  
Intravitreal Aflibercept ◽  
The Mean

Background: To assess long-term structural and functional outcomes of intravitreal aflibercept (Eylea®) treatment for neovascular macular degeneration (nAMD) in a real-word setting. Design and methods: This was a retrospective, single-centre, non-randomized interventional cohort analysis. Data from treatment-naive patients with nAMD funded for treatment with intravitreal aflibercept in the period between 1 September 2013 and 28 February 2014 and who finished 4-year follow-up entered the analysis. Epidemiological data, visual acuity (VA) measured on ETDRS charts and injection numbers were recorded. Spectral domain optical coherence tomography (SD-OCT) data including presence or absence of macular fluid and automated central subfield macular thickness (CSMT) at year 1, 2, 3 and 4 were also recorded. Results: Ninety-four eyes of 89 patients finished 4-year follow-up. The mean number of aflibercept injections received over 4 years was 19.3. At baseline, the mean VA (SD) (Snellen) was 54.1 ± 15.5 (20/100) ETDRS letters whilst the mean CSM (SD) was 296 ± 81 µm. At 4 years, the mean VA (SD) (Snellen) was 60.4 ± 20.0 (20/63) ETDRS letters ( p < 0.0001). Mean CSMT (SD) was 218 ± 79 μm ( p < 0.0001). Thirty-three percent of eyes gained ⩾15 ETDRS letters at end of 4 years, and 66 (70%) eyes had no macular fluid at the end of the follow-up. Conclusion and relevance: The results suggest that good long-term morphological and functional treatment outcomes can be achieved using intravitreal aflibercept for nAMD in a real-life clinical setting.

scholarly journals Visual and anatomical outcomes associated with treat-and-extend administration of intravitreal aflibercept for neovascular age-related macular degeneration

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Mohamed Kamel Soliman ◽  
Nicolas Tuli ◽  
Thomas K. Lee ◽  
William A. Britton ◽  
Raman Tuli
Keyword(s):  
Macular Degeneration ◽  
Subretinal Fluid ◽  
Retrospective Chart Review ◽  
Age Related Macular Degeneration ◽  
Treat And Extend ◽  
Age Related ◽  
Intravitreal Aflibercept ◽  
Treatment Naïve ◽  
The Mean ◽  
Anatomical Outcomes

Abstract Purpose To investigate the visual and anatomical outcomes associated with treat-and-extend (TAE) regimen of intravitreal (IVT) aflibercept in eyes with treatment naïve neovascular age-related macular degeneration (nvAMD). Methods A retrospective chart review of eyes that underwent IVT aflibercept injections for nvAMD between May 2014 and March 2018 was performed. The primary outcome was the change in best corrected visual acuity (BCVA) at 12 months. Secondary outcomes included the change in central retinal thickness (CRT), subretinal fluid (SRF) and intraretinal fluid (IRF). Results Data from 213 eyes of 213 patients (138 female, 65%) met the inclusion criteria. The mean (SD) age of the patients was 80.4 (±  9.2) years. The mean baseline BCVA (0.92  ±  0.50 logMAR, improved by 0.20 (±  0.40) logMAR units at 12 months (p  <  0.001). Seventy-two (34%) eyes gained  ≥  0.3 logMAR and 47 (22%) eyes achieved BCVA  ≤  0.3 logMAR at 12 months. Baseline BCVA, patient age, and the number of aflibercept injections received were predictors of the change in BCVA at 12 months. Mean CRT improved from 347 (±  117) µm at baseline to 246 (±  55) µm at 12 months (p  <  0.001). The percentage of eyes with SRF and IRF on SD-OCT declined from 63 to 21% and from 60 to 26% at 12 months, respectively. Conclusion A TAE regimen of IVT aflibercept in treatment naïve nvAMD is associated with good visual and anatomical outcomes in routine clinical practice. Resolution of exudation occurred in about half of nvAMD cases at 12 months. Individualized administration of IVT aflibercept may reduce injection burden.

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