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

https://doi.org/10.1016/j.ajo.2017.06.002Get rights and content

Purpose

To determine the efficacy and durability of aflibercept used in a treat-and-extend (TAE) regimen for neovascular age-related macular degeneration (NVAMD).

Design

Multicenter, prospective, open label, noncomparative, interventional study.

Methods

Forty eyes of 40 patients with treatment-naïve NVAMD were managed with a TAE regimen of intravitreal aflibercept. The main endpoints were the change in mean and median best-corrected visual acuity from baseline at years 1 and 2. Other endpoints included mean number of annual injections and treatment intervals.

Results

Thirty-five (87.5%) and 31 patients (77.5%) completed year 1 and year 2, respectively. The mean letter gain was 7.2 (P < .001) and 2.4 (P = .269) letters at 1 and 2 years, respectively, from a mean baseline of 58.9 letters (20/63 Snellen equivalent). The median visual gain was 11.5 and 7.5 letters at 1 and 2 years, respectively, from a median baseline of 59.0 letters (20/63 Snellen equivalent). The mean number of injections was 8.0 and 6.5 during the first and second year, respectively. Twelve-week or longer treatment intervals were used in 35% and 38% of patients during the first- and second-year time points, respectively.

Conclusion

Intravitreal aflibercept TAE therapy led to significant visual improvement in eyes with NVAMD at 1 year, with some loss in the visual gains at the end of year 2 that was not related to loss of exudative control. TAE therapy with aflibercept is a rational strategy to reduce treatments and clinic evaluations over 2 years with satisfactory outcomes.

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

References (33)

Cited by (59)

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    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.

  • Machine Learning Can Predict Anti–VEGF Treatment Demand in a Treat-and-Extend Regimen for Patients with Neovascular AMD, DME, and RVO Associated Macular Edema

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    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.

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