Treat-and-Extend Therapy Using Aflibercept for Neovascular Age-related Macular Degeneration: A Prospective Clinical Trial

DeCroos, Francis Char; Reed, David; Adam, Murtaza K.; Salz, David A; Gupta, Omesh P.; Ho, Allen C.; Regillo, Carl D.

doi:10.1016/j.ajo.2017.06.002

Cited by 70 publications

(53 citation statements)

References 32 publications

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“…Since the initial description of the TAE regimen, several studies have reproduced results favouring maintenance or improvement of BCVA similar to monthly dosing while reducing injection frequency and treatment burden. Our study is comparable to others that describe outcomes using a TAE regimen [17][18][19][20][21][22][23]. Similar to our study, BCVA in these studies was either maintained or improved throughout treatment with 30-34% of patients on average improving by 2 to 3 lines and 94-97.5% patients losing less than 2-3 lines.…”

Section: Discussionsupporting

confidence: 90%

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2018

OCR

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This retrospective cross-sectional cohort study describes the long-term visual and anatomic outcomes of anti-Vascular Endothelial Growth Factor (VEGF) treatment using a treat and extend (TAE) regimen. The cohort consisted of 224 treatment-naïve eyes with Age Related Macular Degeneration (NV-AMD) from 202 patients that were treated with anti-VEGF agents bevacizumab, ranibizumab, and aflibercept using a TAE regimen by four physician investigators in a large urban referral center from 2008-2015. Subjects were evaluated for visual acuity, injection frequency and Optical Coherence Tomography (OCT). Over a seven-year follow-up period (mean 3.4 years), average 20.2±14.7 injections were administered per patient. Visual acuity was 0.70 logMAR (20/100 Snellen) at the first visit and 0.67 logMAR (20/93 Snellen) at the final visit, with 74% of eyes maintaining or gaining more than 2 lines of vision. Long-term, 45.1% of eyes achieved 20/50 or better, while 27.1% were 20/200 or worse. 61.2% received monotherapy with no difference in visual acuity outcomes or injection frequency between the agent used. OCT analysis showed decreased fluid from initial to final follow-up visit: 70.1% to 15.6% with Sub-Retinal Fluid (SRF) and 47.3% to 18.8% with Intra-Retinal Fluid (IRF) with no difference between the agent used. This study demonstrates that most patients (74%) improve or maintain visual acuity gains long-term using a TAE model with a significant portion (45.1%) achieving 20/50 or better with sustained treatment.

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Section: Discussionsupporting

confidence: 90%

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2018

OCR

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“…20,21 Recent evidence indicates that T&E therapy with IVT-AFL can also produce good outcomes over 2 years while reducing treatment burden. [22][23][24] Recent consensus guidelines recommend the use of IVT-AFL with a T&E dosing regimen for wAMD management in the Asia-Pacific region, 25 but there is no clear consensus on the most efficacious and cost-effective anti-VEGF treatment regimen.…”

Section: Introductionmentioning

confidence: 99%

<p>Patient Preferences for Anti-Vascular Endothelial Growth Factor Treatment for Wet Age-Related Macular Degeneration in Japan: A Discrete Choice Experiment</p>

Joko¹,

Nagai²,

Mori³

et al. 2020

PPA

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Background: In Japan, intravitreal anti-vascular endothelial growth factor (anti-VEGF) dosing regimens for wet age-related macular degeneration (wAMD) include pro re nata, every 2 months, and treat-and-extend, resulting in different outcomes and patient burden. Although reflecting patient preferences in treatment decision-making is desirable, few studies have examined this in Japan. This study assessed the patients willingness to trade-off between different dosing regimens. Patients and Methods: Patients with wAMD were recruited from four Japanese university hospitals to complete a face-to-face cross-sectional survey. In a discrete choice experiment, patients were asked to choose their preferred option from two anti-VEGF treatment profiles shown side-by-side across a series of choice tasks. The profiles varied on four attributes: number of injections in 12 months, number of physician consultations in 12 months, chance of 1-year visual acuity (VA) improvement, and chance of 2-year VA maintenance. Preference weights were estimated using hierarchical Bayes' models. Results: Overall, 120 patients (30 treatment naïve and 90 anti-VEGF experienced) completed the survey. Patients were willing to accept an increase from three to approximately eight injections in 12 months to increase the chance of 1-year VA improvement from 25% to 40%. They would be willing to accept 11 injections in 12 months if the chance of 2-year VA maintenance increased from 80% to 96%. The most valued attributes were increasing the chance of 2-year VA maintenance and reducing the number of injections in 12 months, which were each about twice as important as decreasing physician consultations in 12 months and increasing the chance of 1-year VA improvement (p<0.001). Among the dosing regimens, patients most preferred treat-and-extend because of its higher chance of 2-year VA maintenance. Conclusion: Informing patients with wAMD about the likelihood of long-term VA maintenance when selecting treatment may increase the acceptance of an optimal treatment regimen and number of injections.

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“…Because of its later approval, there are fewer observational studies evaluating intravitreally administered aflibercept in patients with nAMD; however, these studies indicate that the implementation of a proactive treatment regimen with intravitreally administered aflibercept and an injection frequency consistent with the approved label are associated with RCT-like outcomes in clinical practice [12][13][14][15][16]. In a recent meta-analysis of studies on intravitreally administered aflibercept, researchers included subgroup analyses describing outcomes in RCTs and observational studies [17].…”

Section: Introductionmentioning

confidence: 99%

Real-World Effectiveness and Real-World Cost-Effectiveness of Intravitreal Aflibercept and Intravitreal Ranibizumab in Neovascular Age-Related Macular Degeneration: Systematic Review and Meta-Analysis of Real-World Studies

et al. 2019

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Introduction: Treatment of neovascular agerelated macular degeneration (nAMD) has evolved with the advent of anti-vascular endothelial growth factor agents such that intravitreally administered aflibercept and ranibizumab (RBZ) have become the standard of care. Randomized clinical trials (RCTs) have demonstrated the benefits of these agents in nAMD; however, results achieved under RCT protocols may not always be replicated in clinical practice. Assessing real-world outcomes is important to estimate the effectiveness and cost-effectiveness of these two agents. Our objective was to assess the real-world effectiveness of intravitreally administered aflibercept and RBZ in treatment-naive patients with nAMD and determine the cost-effectiveness of intravitreally administered aflibercept versus RBZ in a real-world setting. Methods: A multistage approach was undertaken. A systematic literature review (SLR) was completed to identify studies describing realworld outcomes in patients with nAMD treated intravitreally with aflibercept or RBZ. A metaanalysis of data identified in the SLR generated a pooled estimate of the effectiveness of intravitreally administered aflibercept and RBZ at 52 weeks and an estimate of treatment burden (injection frequency and monitoring). The impact of treatment effect modifiers, such as baseline visual acuity (VA) and age, were corrected through a multivariable meta-regression. A Markov state transition model was developed to estimate the real-world cost-effectiveness of intravitreally administered aflibercept using results from the pooled estimates for effectiveness and treatment burden as primary inputs. The analysis considered the perspective of the French National Healthcare System. Results: Patients treated intravitreally with aflibercept had a mean age of 79.52 years and mean baseline VA of 55.80 Early Treatment Diabetic Retinopathy Study (ETDRS) letters. At week 52, mean VA gain was 5.30 ETDRS letters in patients reporting an average of 7.10 intravitreal injections of aflibercept and 8.65 visits Enhanced Digital Features To view enhanced digital features for this article go to https://doi.org/10.6084/ m9.figshare.10098272.

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Treat-and-Extend Therapy Using Aflibercept for Neovascular Age-related Macular Degeneration: A Prospective Clinical Trial

Cited by 70 publications

References 32 publications

Untitled

Untitled

<p>Patient Preferences for Anti-Vascular Endothelial Growth Factor Treatment for Wet Age-Related Macular Degeneration in Japan: A Discrete Choice Experiment</p>

Real-World Effectiveness and Real-World Cost-Effectiveness of Intravitreal Aflibercept and Intravitreal Ranibizumab in Neovascular Age-Related Macular Degeneration: Systematic Review and Meta-Analysis of Real-World Studies

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