Efficacy and safety of intravitreal aflibercept using a treat-and-extend regimen for neovascular age-related macular degeneration: the ARIES study

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

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:

27 Aug 2021 01:32

Publisher DOI:

10.1097/IAE.0000000000003128

PubMed ID:

33782365

URI:

https://boris.unibe.ch/id/eprint/156094

Actions (login required)

Edit item Edit item
Provide Feedback