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

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

doi:10.1016/j.oret.2016.12.004

Cited by 96 publications

(95 citation statements)

References 26 publications

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“…In other studies, injection intervals were adjusted by 2-week increments with a set minimum injection interval of 4 weeks and a maximum of 12 weeks [21][22][23]. In ALTAIR, 57-60% of patients achieved a last injection interval of at least 12 weeks up to week 96, compared with 17-37% of patients in other prospective studies of ranibizumab and IVT-AFL T&E regimens [21,[24][25][26]. Up to week 96, 41-46% of patients in ALTAIR reached the maximum last injection interval of 16 weeks either with 2-or 4-week adjustments.…”

Section: Discussionmentioning

confidence: 99%

Efficacy and Safety of Intravitreal Aflibercept Treat-and-Extend Regimens in Exudative Age-Related Macular Degeneration: 52- and 96-Week Findings from ALTAIR

et al. 2020

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Purpose: To evaluate efficacy and safety of intravitreal injections of aflibercept (IVT-AFL) treat-and-extend (T&E) dosing regimens in treatment-naïve patients with exudative agerelated macular degeneration (AMD).Methods: Adults aged at least 50 years old with exudative AMD and best-corrected visual acuity (BCVA) of 73-25 Early Treatment Diabetic Retinopathy Study (ETDRS) letters were included. Patients received three monthly doses of IVT-AFL 2 mg. At week 16, patients were randomized 1:1 to IVT-AFL T&E with either 2-or 4-week adjustments. The primary endpoint was mean change in BCVA from baseline to week 52. Outcomes were assessed at weeks 52 and 96. Results: Baseline characteristics were comparable between the groups (n = 123 each). Over 52 weeks, mean number of injections was 7.2 and 6.9 and mean last injection interval was 10.7 and 11.8 weeks, for the 2-and 4-week groups, respectively. From baseline, mean change in BCVA was ? 9.0 and ? 8.4 letters (week 52) and ? 7.6 and ? 6.1 letters (week 96); mean change in central retinal thickness was -134.4 lm and -126.1 lm (week 52) and -130.5 lm and -125.3 lm (week 96). Last injection interval before week 52 was at least 12 weeks in 42.3% and 49.6% of patients and 56.9% and 60.2% before week 96. Over 96 weeks, mean number of injections was 10.4 (both groups). The safety profile of IVT-AFL was consistent with previous reports. Conclusions: IVT-AFL administered using two different T&E regimens for treatment-naïve exudative AMD improved functional and anatomic outcomes at week 52 and outcomes were Enhanced Digital Features To view enhanced digital features for this article go to https://doi.org/10.6084/ m9.figshare.11603511.maintained to week 96. Outcomes were similar between the 2-and 4-week groups. Trial Registration: ClinicalTrials.gov identifier, NCT02305238. Key Summary PointsWhy carry out this study?The goal of proactive flexible treat-andextend (T&E) regimens is to reduce the treatment burden associated with antivascular endothelial growth factor (VEGF) therapy, while maintaining a patient's visual acuity gains.The aim of this study was to evaluate the efficacy and safety of intravitreal aflibercept (IVT-AFL) T&E dosing regimens in treatment-naïve patients with exudative age-related macular degeneration (AMD).What was learned from the study?IVT-AFL administered using either 2-or 4-week adjustment T&E regimens in treatment-naïve patients with exudative AMD improved functional (best-corrected visual acuity ? 9.0 and ? 8.4 letters) and anatomic outcomes (central retinal thickness -134.4 and -126.1 lm) at 52 weeks; functional and anatomic outcomes were maintained over 96 weeks.A large proportion of patients (35.1% and 40.5%) had an intended injection interval of 16 weeks at week 52.The incidence of treatment-emergent adverse events was consistent with the known safety profile of IVT-AFL.IVT-AFL T&E regimens were efficacious and safe over 96 weeks of treatment using either 2-or 4-week adjustments.

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Section: Discussionmentioning

confidence: 99%

Efficacy and Safety of Intravitreal Aflibercept Treat-and-Extend Regimens in Exudative Age-Related Macular Degeneration: 52- and 96-Week Findings from ALTAIR

et al. 2020

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“…Fixed-interval bevacizumab every 4-6 weeks with no OCT monitoring and variable dosing regimens of intravitreal bevacizumab based on OCT monitoring both result in similar improvement in visual acuity and central macular thickness, but with more injections (9.5 vs. 3.8 injections during 1 year follow up) in the fixed treatment group [7,8]. Thus, an ideal treatment schedule for the COVID-19 era, which minimizes the number of visits while showing non-inferior visual outcome is TER [9,10].…”

Section: Rescheduling Of Patientsmentioning

confidence: 99%

Current safety preferences for intravitreal injection during COVID-19 pandemic

Shmueli

Chowers

Levy

2020

Eye

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“…Upon inactive disease, patients in the latter group received an injection, and the Optimizing Anti-VEGF Treatment Outcomes for Patients with Neovascular Age-Related Macular Degeneration treatment interval was extended by 2 weeks at a time for a maximum interval of 12 weeks. 70,71 Recurrence of disease activity was designated by intraretinal or subretinal fluid on OCT. At 2 years, the monthly and treat-and-extend groups did not differ significantly in improvements of VA (+10.5 and +8.7 letters) or CRT (-117 and -118 µm). Significantly more injections were given to patients treated monthly (25.5) compared with the alternate regimen (18.6; P < 0.001).…”

Section: Optimizing Anti-vegf Treatment Outcomes For Patients With Nementioning

confidence: 99%

“…68 No cases of this event were reported in the TREX-AMD trial, and 1 of the 40 patients in the ATLAS trial had culture-positive endophthalmitis. 71 The recently published results from the large TREND trial showed that the treat-and-extend regimen of 0.5 mg ranibizumab was noninferior to monthly ranibizumab dosing with a least squares mean BCVA change from baseline of 6.2 and 8.1 letters, respectively. These BCVA changes occurred within 6 months of treatment and were stable in both arms.…”

Section: Optimizing Anti-vegf Treatment Outcomes For Patients With Nementioning

confidence: 99%

Optimizing Anti-VEGF Treatment Outcomes for Patients with Neovascular Age-Related Macular Degeneration

Wykoff¹,

Clark²,

Nielsen³

et al. 2018

JMCP

Self Cite

104

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PRIME Education is an independent medical education company and has been an accredited provider of continuing education for 23 years. There is no fee for this activity as it is sponsored by PRIME through an educational grant from Regeneron. All authors contributed to the writing and reviewing of the article. Wykoff reports consultancies/research grants from Alcon Laboratories, Genentech/Roche, Clearside, and Iconic Therapeutics; consultancies/honoraria, research grants, and speaker fees from Allergan and Regeneron; research grants from Allegro, Apellis, Aura, NEI, NIH, Novartis, OHR Pharmaceuticals, Ophthotech, pSivida, Roche, Santen, SciFluor, Tyrogenex; and consultancies for Alimera Sciences, Alnylam Pharmaceuticals, Bayer, DORC, ONL Therapeutics, Thrombogenics, and Valeant. Clark reports advisory board work, consultancies, research grants, and speaker fees from Genentech/Roche and Regeneron and consultancy for Bayer. Brill reports consultancies for Aries Pharma, Avella, BaroNova, Braeburn Pharmaceuticals, Cardinal Health, Endogastric Solutions, GeneNews, Halt Medical, Lumendi, Medtronic, Monteris Medical, Natera, Phosphorus, Rebiotix, Seno Medical, UCB, Vermillion, Echosens, and HAP Innovations. Brill is a shareholder in EndoChoice, GeneNews, SonarMD, and SynerZ and reports advisory board work with Nestle Health Sciences, Indivior Pharmaceuticals, Eli Lilly, Blue Earth Diagnostics, Bayer, and AstraZeneca. Nielson reports advisory board work/consultancy and research grants for Genentech/Roche; advisory board work and research grants from Regeneron; and research grants from Alcon and Ophthotech.

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

Cited by 96 publications

References 26 publications

Efficacy and Safety of Intravitreal Aflibercept Treat-and-Extend Regimens in Exudative Age-Related Macular Degeneration: 52- and 96-Week Findings from ALTAIR

Efficacy and Safety of Intravitreal Aflibercept Treat-and-Extend Regimens in Exudative Age-Related Macular Degeneration: 52- and 96-Week Findings from ALTAIR

Current safety preferences for intravitreal injection during COVID-19 pandemic

Optimizing Anti-VEGF Treatment Outcomes for Patients with Neovascular Age-Related Macular Degeneration

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