In:
Retina, Ovid Technologies (Wolters Kluwer Health), Vol. 41, No. 9 ( 2021-09), p. 1911-1920
Abstract:
Treating neovascular age-related macular degeneration with intravitreal aflibercept treat-and-extend (T & E) can reduce treatment burden. ARIES assessed whether intravitreal aflibercept early-start T & E was noninferior to late-start T & E. Methods: A randomized, open-label, Phase 3b/4 study that included treatment-naïve patients aged ≥50 years with the best-corrected visual acuity 73–25 Early Treatment Diabetic Retinopathy Study letters and active choroidal neovascularization secondary to AMD. Patients received 2 mg intravitreal aflibercept at Week (W) 0, W4, W8, and W16. At W16, patients were randomized 1:1 to early-start (2W interval adjustments) or late-start T & E (8W intervals until W48 then 2W interval adjustments). Primary endpoint: the best-corrected visual acuity change from randomization to W104. Results: Two-hundred seventy-one patients were randomized. The mean (SD) best-corrected visual acuity at baseline was 60.2 (12.1; early-T & E) and 61.3 (10.8; late-T & E) letters. The mean (SD) best-corrected visual acuity change (W16–104) was −2.1 (11.4) versus −0.4 (8.4) letters (early-T & E vs. late-T & E; least-squares mean difference: −2.0; 95% confidence interval: −4.75 to 0.71; P = 0.0162 for noninferior); +4.3 (13.4) versus +7.9 (11.9) letters (W0–104). The mean (SD) number of injections was 12.0 (2.3) versus 13.0 (1.8). From baseline to W104, 93.4% and 96.2% maintained best-corrected visual acuity; the mean (SD) central retinal thickness change was −161.6 (135.6) µ m and −158.6 (125.1) µ m. The last injection interval (W104) was ≥12W for 47.2% and 51.9% of patients. Conclusion: Outcomes were similar between patients with neovascular age-related macular degeneration treated with an intravitreal aflibercept early-T & E or late-T & E regimen after initial dosing, with one injection difference over 2 years. Trial Registration: ClinicalTrials.gov Identifier: NCT02581891 https://clinicaltrials.gov/ct2/show/NCT02581891. Supplemental Digital Contents (files 1 http://links.lww.com/IAE/B419).
Type of Medium:
Online Resource
ISSN:
0275-004X
DOI:
10.1097/IAE.0000000000003128
Language:
English
Publisher:
Ovid Technologies (Wolters Kluwer Health)
Publication Date:
2021
detail.hit.zdb_id:
2071014-8
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