Mitchell, Paul; Holz, Frank G; Hykin, Philip; Midena, Edoardo; Souied, Eric; Allmeier, Helmut; Lambrou, George; Schmelter, Thomas; Wolf, Sebastian (2021). Efficacy and safety of intravitreal aflibercept using a treat-and-extend regimen for neovascular age-related macular degeneration: the ARIES study. Retina, 41(9), pp. 1911-1920. Wolters Kluwer 10.1097/IAE.0000000000003128
Full text not available from this repository. (Request a copy)PURPOSE
Treating neovascular age-related macular degeneration (nAMD) with intravitreal aflibercept (IVT-AFL) treat-and-extend (T&E) can reduce treatment burden. ARIES assessed whether IVT-AFL early-start T&E was noninferior (NI) to late-start T&E.
METHODS
A randomized, open-label, Phase 3b/4 study that included treatment-naïve patients aged ≥50 years with best-corrected visual acuity (BCVA) 73-25 Early Treatment Diabetic Retinopathy Study letters and active choroidal neovascularization secondary to AMD. Patients received 2mg IVT-AFL 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: BCVA change from randomization to W104.
RESULTS
271 patients were randomized. Mean (standard deviation [SD]) BCVA at baseline was 60.2 (12.1; early-T&E) and 61.3 (10.8; late-T&E) letters. Mean (SD) BCVA change (W16-104) was -2.1 (11.4) vs -0.4 (8.4) letters (early- vs late-T&E; least-squares mean difference: -2.0; 95% CI: -4.75 to 0.71; P=0.0162 for NI); +4.3 (13.4) vs +7.9 (11.9) letters (W0-104). Mean (SD) number of injections was 12.0 (2.3) vs 13.0 (1.8). From baseline to W104, 93.4% and 96.2% maintained BCVA; mean (SD) central retinal thickness change was -161.6 (135.6) µm and -158.6 (125.1) µm. Last injection interval (W104) was ≥12W for 47.2% and 51.9% of patients.
CONCLUSION
Outcomes were similar between patients with nAMD treated with an IVT-AFL early- or late-T&E regimen following initial dosing, with one injection difference over 2 years.
Item Type: |
Journal Article (Original Article) |
|---|---|
Division/Institute: |
04 Faculty of Medicine > Department of Head Organs and Neurology (DKNS) > Clinic of Ophthalmology |
UniBE Contributor: |
Wolf, Sebastian (B) |
Subjects: |
600 Technology > 610 Medicine & health |
ISSN: |
1539-2864 |
Publisher: |
Wolters Kluwer |
Language: |
English |
Submitter: |
Sebastian Wolf |
Date Deposited: |
28 Apr 2021 10:46 |
Last Modified: |
05 Dec 2022 15:51 |
Publisher DOI: |
10.1097/IAE.0000000000003128 |
PubMed ID: |
33782365 |
URI: |
https://boris.unibe.ch/id/eprint/156094 |
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