Original articleTreat-and-Extend Therapy Using Aflibercept for Neovascular Age-related Macular Degeneration: A Prospective Clinical Trial
Section snippets
Study Design
This prospective, open-label, multicenter, investigator-sponsored clinical study enrolled 40 patients. Prospective Institutional Review Board (IRB) approval was obtained (#20122054), all experimental procedures adhered to the tenets of the Declaration of Helsinki, and all participants engaged in an informed consent process and signed a written consent document prior to enrollment in the ATLAS (ClinicalTrials.gov Identifier: NCT01773954). The criteria for study inclusion included patients of age
Patients, Follow-up, and Treatments
Forty patients were enrolled across 4 clinical sites in 3 states of 2 practices (Mid Atlantic Retina and Southeastern Retina Associates). Of these patients, 35 (87.5%) completed the year 1 visit and 31 (77.5%) completed the year 2 visit. The mean patient age at baseline was 81.3 years; 17 patients (42.5%) were male and 23 (57.5%) were female (Table 1). No patients experienced a myocardial infarction, cerebrovascular accident (CVA), and/or transient ischemic attack prior to enrollment.
Visual Acuity Outcomes
An
Discussion
A TAE-style dosing regimen for NVAMD can diminish the need for intensive monthly follow-up and treatment as modeled in multiple pivotal clinical trials and still allow for similar visual and anatomic outcomes.18, 19, 20, 21 ATLAS is one of the first studies to prospectively report the efficacy of a TAE-style dosing regimen with aflibercept for treatment-naïve NVAMD. In the present study, a mean gain of 7.2 letters and a median gain of 11.5 letters was demonstrated at 1 year, which was similar
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Cited by (59)
Archway Randomized Phase 3 Trial of the Port Delivery System with Ranibizumab for Neovascular Age-Related Macular Degeneration
2022, OphthalmologyCitation Excerpt :In Archway, effective nAMD disease control with a reduced treatment frequency was achieved in almost all PDS-treated patients, with 98.4% of patients in the PDS arm assessed as not receiving supplemental ranibizumab treatment before the first refill-exchange procedure at week 24. These results are notable because data indicate that available intravitreal anti-VEGF agents allow for treatment extension to 8- or 12-week intervals in a subset of patients22–25 and generally require at least 7 treatments in the first year to achieve efficacy comparable with that of monthly injections.2,26,27 The high proportion of PDS-treated patients in Archway who maintained nAMD disease control without supplemental treatment demonstrated efficacy of continuous ranibizumab delivery and supported the potential for the PDS to reduce the overall treatment and monitoring burden in clinical practice.
First-dose effects with intravitreal aflibercept in wet age-related macular degeneration: a post-hoc analysis of VIEW-1 and VIEW-2 phase 3 studies
2021, Canadian Journal of OphthalmologyMachine Learning Can Predict Anti–VEGF Treatment Demand in a Treat-and-Extend Regimen for Patients with Neovascular AMD, DME, and RVO Associated Macular Edema
2021, Ophthalmology RetinaCitation Excerpt :Third, the loading dose targets a maximum initial treatment response, which is always achieved in a TER because consensus exists for administering monthly injections until disease inactivity is achieved.27 Also, several large prospective trials in which a loading phase was not mandatory achieved similar results as trials using a loading dose.16,40,41 Fourth, a recent publication42 observed that a loading dose is not necessary to achieve results in a real-life setting, findings that are comparable with the outcome of clinical trials.
The Effect of a Loading Dose Regimen in the Switch to Brolucizumab for Patients with Aflibercept-Resistant nAMD
2024, Journal of Ophthalmology
Supplemental Material available at AJO.com.