Prospective Trial of Treat-and-Extend versus Monthly Dosing for Neovascular Age-Related Macular Degeneration

Wykoff, Charles C.; Croft, Daniel E.; Brown, David M.; Wang, Rui; Payne, John F.; Clark, Lloyd; Abdelfattah, Nizar Saleh; Sadda, Srinivas R

doi:10.1016/j.ophtha.2015.08.009

Cited by 233 publications

(191 citation statements)

References 27 publications

(35 reference statements)

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“…The tariffs were obtained from the clinical coding department in our trust. We compared our data using the Year 1 VIEW protocol with data from Wycoff et al's 9 RCT for treat-and-extend dosing, 7 PrONTO study data for PRN dosing, 8 and ANCHOR study data for monthly dosing. The net price for aflibercept 40 mg/ml solution for intravitreal injection is £816.00 per 0.1 ml vial.…”

Section: Discussionmentioning

confidence: 99%

One-year real-world outcomes in patients receiving fixed-dosing aflibercept for neovascular age-related macular degeneration

Almuhtaseb

Kanavati

Rufai

et al. 2017

Eye

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Purpose To investigate 1-year visual and anatomic outcomes of intravitreal aflibercept for neovascular age-related macular degeneration (nAMD) given at a fixed 8-weekly interval. Methods Retrospective, single-practice data analysis from an electronic medical record system of 255 eyes (223 patients) with treatment-naïve nAMD receiving 8-weekly aflibercept.Results Mean logarithm of the minimum angle of resolution best-corrected visual acuity (BCVA) improved from 0.66 at baseline to 0.50 at month 11 (Po0.0001). Mean central retinal thickness (CRT) decreased from 311μm at baseline to 211μm at month 11 (Po0.0001). Our mean VA gain of eight ETDRS letters was comparable to the VIEW 1 and VIEW 2 Trials' results at the end of year 1. After loading at month 5, mean BCVA was 0.48 (Po0.0001), and mean CRT was 235 μm. At month 5, 143 eyes (56%) were inactive defined by the absence of macular haemorrhage and intraretinal fluid (IRF) and subretinal fluid (SRF) on optical coherence tomography, and 112 eyes (44%) remained active. At month 11, 136 eyes (53%) were inactive, and 119 eyes (47%) remained active. At month 11, 77% of inactive eyes after loading remained inactive, and 77% of the active eyes after loading remained active. At month 11, mean BCVA of the inactive group was 0.51, and mean BCVA of the active group was 0.48 (P = 0.54). Conclusions Aflibercept administered by fixed dosing over 1 year improved VA and macular morphology in treatment-naïve eyes. Active lesions at month 11 do not have worse VA outcomes compared with inactive lesions. The macular status after loading is a reliable indicator of disease activity at the end of year 1.

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Section: Discussionmentioning

confidence: 99%

One-year real-world outcomes in patients receiving fixed-dosing aflibercept for neovascular age-related macular degeneration

Almuhtaseb

Kanavati

Rufai

et al. 2017

Eye

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“…In 1 report, the difference of both groups was recorded as follows: 7.8 ± 1.3 injections in the TER versus 5.2 ± 1.9 injections in the PRN group [12] . Beside the so far mentioned papers, several other studies were conducted to evaluate the efficacy of TER in neovascular AMD using ranibizumab and bevacizumab [7,[13][14][15][16] . Different TER protocols were applied in respective studies but most of them increased the treatment intervals by 2 weeks per visit, unless evidence for disease activity was present.…”

Section: Discussionmentioning

confidence: 99%

Outcomes when Switching from a pro re nata Regimen to a Treat and Extend Regimen Using Aflibercept in Neovascular Age-Related Macular Degeneration

Giannakaki-Zimmermann

Ebneter

Munk

et al. 2016

Ophthalmologica

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Purpose: To investigate outcomes in patients with neovascular age-related macular degeneration (AMD) switched from a pro re nata regimen (PRN) to a treat and extend regimen (TER) under aflibercept. Procedure: Thirty-two patients were observed over 2 years: the first year on PRN and the second year on TER. Best-corrected visual acuity (BCVA) and central retinal thickness (CRT) were evaluated. Intra- and subretinal fluid as well as the number of visits and injections were assessed. Results: Both regimens resulted in a stable BCVA. Patients in TER had a significant decrease of CRT after 1 year compared to 1 year of treatment on PRN (p < 0.0001). TER resulted in significantly less visits; however, significantly more injections were observed over the course of 1 year compared to PRN (10.25 vs. 7.5, p < 0.0001 and 5.97 vs. 7.5, p = 0.0002, respectively). Conclusion: A switch from PRN to TER in patients treated with aflibercept for AMD appears to be safe.

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“…The number of intravitreal anti-VEGF injections performed worldwide has increased exponentially in the past decade, and multiple intravitreal injections over a period of months or years may be required to treat these diseases [3, 4]. Even though less frequent dosing such as treat and extend or as-needed regimens have been proven to be efficient in various clinical trials, many patients frequently still require monthly injections [1, 5, 6]. In addition, patients often show up with bilateral eye involvement, and the rate of bilateral anti-VEGF treatment has been described as 36% for nAMD and 48% for DME [7-9].…”

Section: Introductionmentioning

confidence: 99%

Same-Day Bilateral Intravitreal Anti-Vascular Endothelial Growth Factor Injections: Experience of a Large Canadian Retina Center

et al. 2019

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Objective: To evaluate the outcomes and complications of bilateral same-day intravitreal anti-vascular endothelial growth factor (anti-VEGF) injections. Methods: This is a single-center, retrospective study that included 524 eyes of 262 patients who received concomitant bilateral intravitreal anti-VEGF injections in 2016 at St. Michael’s Hospital, Toronto. If any of the patients were receiving simultaneous bilateral injections on a regular basis prior to 2016, data pertaining to previous injections were also reviewed. Everyone received bevacizumab, ranibizumab, or aflibercept in an office setting. Results: A total of 9,798 intravitreal anti-VEGF injections (4,899 bilateral injection sessions) were performed in 524 eyes of 262 patients. The average number of bilateral injection sessions per patient was 18.7 ± 14.1. Ranibizumab was the most commonly used anti-VEGF drug (83.8%). The incidence of endophthalmitis was 0.01%, and there were 2 episodes of acute intraocular inflammation among the 9,798 injections (0.02%). All 3 cases occurred after treatment with ranibizumab. There were 2 deaths (0.76%) due to nonvascular causes but no vascular related systemic adverse events were reported. Conclusions: Same-day bilateral intravitreal anti-VEGF injections present a low rate of complications and are well tolerated by patients. This safe practice may reduce the burden on the health-care system and on the patients.

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Prospective Trial of Treat-and-Extend versus Monthly Dosing for Neovascular Age-Related Macular Degeneration

Abstract: The TREX neovascular AMD management strategy used in this prospective, randomized, controlled trial resulted in visual and anatomic gains comparable with those obtained with monthly dosing.

Cited by 233 publications

References 27 publications

One-year real-world outcomes in patients receiving fixed-dosing aflibercept for neovascular age-related macular degeneration

One-year real-world outcomes in patients receiving fixed-dosing aflibercept for neovascular age-related macular degeneration

Outcomes when Switching from a pro re nata Regimen to a Treat and Extend Regimen Using Aflibercept in Neovascular Age-Related Macular Degeneration

Same-Day Bilateral Intravitreal Anti-Vascular Endothelial Growth Factor Injections: Experience of a Large Canadian Retina Center

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