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.

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.

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.

Visual Outcomes after Anti-VEGF Therapy for Exudative Age-Related Macular Degeneration in a Real-Life Setting

2021 ◽  
Vol 238 (04) ◽  
pp. 396-402
Author(s):  
Andrea R. Wenkstern ◽  
Christophe Valmaggia
Keyword(s):  
Macular Degeneration ◽  
Real Life ◽  
Case Series ◽  
Age Related Macular Degeneration ◽  
Serious Adverse Events ◽  
Visual Outcomes ◽  
Anti Vegf ◽  
Age Related ◽  
Real Life Setting

Abstract Background To report visual outcomes of anti-vascular endothelial growth factor (anti-VEGF) therapy for exudative age-related macular degeneration (AMD) in a real-life setting. Patients and Methods Retrospective case series of consecutive patients treated with either ranibizumab and/or aflibercept for monolateral or bilateral exudative AMD. A physician established the indication for treatment and administered the injections. An independent physician confirmed the indication for primary treatment. A Pro Re Nata and a Treat and Extend regimen were used. Assessment of subretinal and/or intraretinal fluid, retinal hemorrhage and increase in pigment epithelial detachment served as criteria for further treatment decisions. Visual acuity (VA) was measured in ETDRS letters at each examination and then analyzed using a specialized software. Evolution of mean VA was considered for all study eyes and subgroups of eyes with an initial VA ≥ 70 ETDRS letters (subgroup 1) and ≤ 69 ETDRS letters (subgroup 2). Results A total of 102 eyes of 76 patients (30 men, mean age 75.9 years; 46 women, mean age 81.5 years) were included. Subgroup 1 consisted of 47 eyes, and subgroup 2 of 55 eyes. Mean follow-up was 55 months (range 6 to 150 months). For the entire collective as for subgroups 1 and 2, the mean VA was 64, 77, or 51 ETDRS letters at baseline. Mean VA improved at month 12 (68, 80, or 58 ETDRES letters) and then slowly decreased over time until month 150 (62, 72, or 54 ETDRS letters). Maximum improvement of + 5, + 3, or, + 9 ETDRS letters occurred after 9, 8, or 10 months of follow-up. Atrophy and fibrosis were mainly responsible for VA decrease. Ten serious adverse events were reported to Swissmedic: two cases of cardiovascular events and eight cases of intraocular inflammation. Conclusions Anti-VEGF therapy carried out in a real-life setting shows good VA outcomes with a favorable safety profile.

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.

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 Comparative Analysis of the Clinical Features and Long-Term Outcomes of Pachychoroid Neovasculopathy and Type 1 Neovascular Age-Related Macular Degeneration

2020 ◽  
Vol 2020 ◽  
pp. 1-6
Author(s):  
Jong In You ◽  
Kiyoung Kim
Keyword(s):  
Macular Degeneration ◽  
Age Related Macular Degeneration ◽  
Long Term Outcomes ◽  
Age Related ◽  
Treatment Naïve ◽  
History Of ◽  
Pachychoroid Neovasculopathy

Purpose. To evaluate the clinical characteristics and long-term prognosis of pachychoroid neovasculopathy (PCN) when compared with type 1 neovascular age-related macular degeneration (nAMD). Methods. We retrospectively analyzed 30 and 60 patients whose eyes were diagnosed as treatment-naïve PCN or type 1 nAMD, respectively. All subjects were followed up for 5 years. Baseline angiographic characteristics and long-term clinical outcomes were compared between the two groups. Results. PCN group consisted of patients of younger age and represented more choroidal vascular hyperpermeability, polypoidal lesion, and history of central serous chorioretinopathy (CSC) at the time of diagnosis (all p  < 0.01). During the 5-year follow-up period, individuals in the PCN group received significantly fewer injections and reported better visual acuity compared to individuals in the type 1 nAMD group. A progressive decrease in the subfoveal choroidal thickness was observed in the type 1 nAMD group, while the thick choroid was maintained in the PCN group during the 5-year follow-up period. Conclusions. PCN developed in younger patients with a higher propensity of forming polypoidal lesions and a history of CSC. Long-term outcomes revealed that PCN had a thicker choroid and better visual prognosis with fewer number of intravitreal injection than that of type 1 nAMD.

scholarly journals Implementation of An Intravitreal Therapy Online Audit Tool For Neovascular Age-related Macular Degeneration Clinical Outcomes Reporting: Fight Retinal Blindness Spain (FRB-Spain) Project

2021 ◽  
Author(s):  
Alba Parrado-Carrillo ◽  
Marc Figueras-Roca ◽  
Ricardo P. Casaroli-Marano ◽  
Vuong Nguyen ◽  
Daniel Barthelmes ◽  
...  
Keyword(s):  
Macular Degeneration ◽  
Subgroup Analysis ◽  
Real Life ◽  
Age Related Macular Degeneration ◽  
Audit Tool ◽  
Intravitreal Therapy ◽  
Tertiary Referral Center ◽  
Anti Vegf ◽  
Age Related ◽  
Number Of Injections

Abstract Purpose: To implement an intravitreal therapy audit tool for neovascular age-related macular degeneration (nAMD) outcome reporting in a tertiary referral center. Methods: Implementation of an online audit tool (Fight Retinal Blindness platform) for nAMD eyes receiving anti-vascular endothelial growth factor (anti-VEGF) intravitreal therapy over a 24-month follow-up period. Data entry was compliant with the ICHOM dataset for nAMD. These data included visual acuity (VA), eye conditions, injection drug and number of injections. Subgroup analysis was performed for treatment-naive (TN) and previously treated (PT) eyes. Results: 234 eyes (191 patients) were included in the study. No significant differences were observed in the subgroup analysis in mean baseline VA (logMAR letters: 58.8 TN vs 62.7 PT, p= 0.081) or final VA at 12 months (TN 61.4 vs PT 62.4; p= 0.703). However, 12 months median VA change favoured TN cases (+4 TN vs +0 PT, p= 0.010) and median number of injections showed no differences (7 TN vs 7 PT, p= 0.644). No statistically significant differences were found at two years on number of injections even though mean final VA showed significant differences (66 TN vs 59.5 PT, p = 0.032) and VA change favoured the TN group (+2.4 TN vs - 4.6 PT, p= 0.003).Conclusion: We have successfully implemented an online tool to evaluate nAMD anti-VEGF treatment delivered in our center. This feasibility study demonstrates that the online audit tool allows evaluating real world intravitreal therapy outcomes and benchmark these results with clinical practice guidelines and other real-life series.

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.

Neovascular age-related macular degeneration treated with ranibizumab or aflibercept in the same large clinical setting: visual outcome and number of injections

2016 ◽  
Vol 95 (2) ◽  
pp. 128-132 ◽  
Author(s):  
Annette Rasmussen ◽  
Birgit Sander ◽  
Michael Larsen ◽  
Sara Brandi ◽  
Josefine Fuchs ◽  
...  
Keyword(s):  
Macular Degeneration ◽  
Clinical Setting ◽  
Visual Outcome ◽  
Age Related Macular Degeneration ◽  
Age Related ◽  
Number Of Injections
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