Clinical Outcomes of Aflibercept Treatment for Treatment-naive Exudative Age-related Macular Degeneration

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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Real‐world outcomes of anti‐VEGF therapy in treatment‐naïve neovascular age‐related macular degeneration diagnosed on OCT angiography: the REVEAL study

Acta Ophthalmologica ◽

10.1111/aos.15005 ◽

2021 ◽

Author(s):

Marco Lupidi ◽

Stefano Schiavon ◽

Alessio Cerquaglia ◽

Daniela Fruttini ◽

Ramkailash Gujar ◽

...

Keyword(s):

Macular Degeneration ◽

Real World ◽

Age Related Macular Degeneration ◽

Oct Angiography ◽

Anti Vegf ◽

Age Related ◽

Reveal Study ◽

Treatment Naïve

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

Therapeutic Advances in Ophthalmology ◽

10.1177/2515841420903929 ◽

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.

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Ten-year survival trends of neovascular age-related macular degeneration at first presentation

British Journal of Ophthalmology ◽

10.1136/bjophthalmol-2020-317161 ◽

2020 ◽

pp. bjophthalmol-2020-317161

Author(s):

Cristina Arpa ◽

Hagar Khalid ◽

Shruti Chandra ◽

Siegfried Wagner ◽

Katrin Fasler ◽

...

Keyword(s):

Macular Degeneration ◽

Age Related Macular Degeneration ◽

Visual Outcomes ◽

Anti Vegf ◽

Kaplan Meier ◽

Age Related ◽

Treatment Naïve ◽

Mean Trend ◽

Endothelial Growth Factor ◽

Good Vision

BackgroundTo describe 10-year trends in visual outcomes, anatomical outcomes and treatment burden of patients receiving antivascular endothelial growth factor (anti-VEGF) therapy for neovascular age-related macular degeneration (nAMD).MethodsRetrospective cohort study of treatment-naïve, first-affected eyes with nAMD started on ranibizumab before January 1, 2009. The primary outcome was time to best-corrected visual acuity (BCVA) falling ≤35 ETDRS letters after initiating anti-VEGF therapy. Secondary outcomes included time to BCVA reaching ≥70 letters, proportion of eyes with BCVA ≥70 and ≤35 letters in 10 years, mean trend of BCVA and central retinal thickness over 10 years, and mean number of injections.ResultsFor our cohort of 103 patients, Kaplan-Meier analyses demonstrated median time to BCVA reaching ≤35 and ≥70 letters were 37.8 (95% CI 22.2 to 65.1) and 8.3 (95% CI 4.8 to 20.9) months after commencing anti-VEGF therapy, respectively. At the final follow-up, BCVA was ≤35 letters and ≥70 letters in 41.1% and 21%, respectively, in first-affected eyes, while this was the case for 5.4% and 48.2%, respectively, in a patient’s better-seeing eye. Mean injection number was 37.0±24.2 per eye and 53.6±30.1 at patient level (63.1% of patients required injections in both eyes).ConclusionsThe chronicity of nAMD disease and its management highlights the importance of long-term visual prognosis. Our analyses suggest that one in five patients will retain good vision (BCVA ≥70 ETDRS letters) in the first-affected eye at 10 years after starting anti-VEGF treatment; yet, one in two patients will have good vision in their better-seeing eye. Moreover, our data suggest that early treatment of nAMD is associated with better visual outcomes.

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

British Journal of Ophthalmology ◽

10.1136/bjophthalmol-2020-316514 ◽

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.

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Prospective Audit of Exudative Age-Related Macular Degeneration: 12-Month Outcomes in Treatment-Naïve Eyes

Investigative Opthalmology & Visual Science ◽

10.1167/iovs.13-11993 ◽

2013 ◽

Vol 54 (8) ◽

pp. 5754 ◽

Cited By ~ 24

Author(s):

Mark C. Gillies ◽

Richard Walton ◽

Judy M. Simpson ◽

Jennifer J. Arnold ◽

Robyn H. Guymer ◽

...

Keyword(s):

Macular Degeneration ◽

Age Related Macular Degeneration ◽

Prospective Audit ◽

Age Related ◽

Treatment Naïve

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

Journal of Ophthalmology ◽

10.1155/2020/8865743 ◽

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.

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RANIBIZUMAB TREATMENT IN TREATMENT-NAIVE NEOVASCULAR AGE-RELATED MACULAR DEGENERATION

Retina ◽

10.1097/iae.0000000000002670 ◽

2019 ◽

Vol 40 (9) ◽

pp. 1673-1685 ◽

Cited By ~ 9

Author(s):

Frank G. Holz ◽

Marta S. Figueroa ◽

Francesco Bandello ◽

Yit Yang ◽

Masahito Ohji ◽

...

Keyword(s):

Macular Degeneration ◽

Age Related Macular Degeneration ◽

Age Related ◽

Treatment Naïve ◽

Ranibizumab Treatment

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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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Comparison of cytokine levels in the aqueous humor of polypoidal choroidal vasculopathy and neovascular age-related macular degeneration patients

BMC Ophthalmology ◽

10.1186/s12886-019-1278-8 ◽

2020 ◽

Vol 20 (1) ◽

Cited By ~ 3

Author(s):

Huiying Zhou ◽

Xinyu Zhao ◽

Mingzhen Yuan ◽

Youxin Chen

Keyword(s):

Macular Degeneration ◽

Aqueous Humor ◽

Polypoidal Choroidal Vasculopathy ◽

Age Related Macular Degeneration ◽

Logistic Analysis ◽

Age Related ◽

Cytokine Levels ◽

Treatment Naïve ◽

And Control ◽

Choroidal Vasculopathy

Abstract Background The concentrations of cytokines in the aqueous humor from neovascular age-related macular degeneration (nAMD) and polypoidal choroidal vasculopathy (PCV) may vary. The study was conducted to compare various cytokine levels in the aqueous humor of eyes with PCV, nAMD and control. Methods The present case control study included 49 treatment-naïve eyes from 49 patients (PCV 24, nAMD 11, and cataract 14 eyes). Totally 34 angiogenic and inflammatory cytokines in the aqueous humor were measured by Luminex bead-based multiplex array. Results After adjusting for gender and age by multivariate logistic analysis, concentrations of IL-31, LIF, SDF1-α, VEGF-A, VEGF-D were significantly higher in eyes with nAMD or PCV compared with control eyes (all P < 0.05, times in nAMD: 59.5, 6.0, 7.0, 4.5, 5.6, respectively, times in PCV: 51.9, 5.21, 6.6, 4.0, 5.1, respectively), and concentrations of HGF, IP-10, MCP-1, IL-13 were significantly lower in eyes with nAMD or PCV than in control eyes (all P < 0.05, times in nAMD: 2.6, 2.0, 4.5, 4.7, respectively, times in PCV: 1.9, 3.0, 3.0, 2.8, respectively), but none of the 34 cytokines, including VEGF and IL-8, showed significantly different between eyes with nAMD and PCV. Conclusions Various cytokines involved in inflammation and angiogenesis including elevated IL-31, LIF, SDF1-α, VEGF-A, VEGF-D might be involved in the pathogenesis of nAMD or PCV. None of the 34 cytokines may help to differentiate nAMD and PCV.

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