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Randomized Controlled Trial
. 2017;238(4):205-216.
doi: 10.1159/000478665. Epub 2017 Sep 2.

SAVE-AMD: Safety of VEGF Inhibitors in Age-Related Macular Degeneration

Frank Enseleit  1 , Stephan Michels, Isabella Sudano, Marc Stahel, Sandrine Zweifel, Oliver Schlager, Matthias Becker, Stephan Winnik, Matthias Nägele, Andreas J Flammer, Michel Neidhart, Nicole Graf, Christian M Matter, Burkhardt Seifert, Thomas F Lüscher, Frank Ruschitzka
Affiliations
Randomized Controlled Trial

SAVE-AMD: Safety of VEGF Inhibitors in Age-Related Macular Degeneration

Frank Enseleit et al. Ophthalmologica. 2017.

Abstract

Objective: To determine whether intraocular treatment with vascular endothelial growth factor (VEGF) inhibitors change systemic endothelial function (EF) in patients with neovascular age-related macular degeneration (AMD).

Methods: In this prospective, randomized, 2-center, double-masked controlled interventional trial, patients with neovascular and dry AMD were enrolled. Eligible neovascular AMD patients received 2 intravitreal loading doses of either ranibizumab 0.5 mg or bevacizumab 1.25 mg at 4-week intervals and were subsequently followed every 4 weeks and treated according to a pro re nata regime for up to 1 year. Patients with dry AMD served as controls. The primary endpoint was the change in EF assessed by flow-mediated dilatation (FMD) after 2 months of treatment with VEGF inhibitors in patients with AMD compared to patients with dry AMD. FMD was assessed with B-mode high-resolution ultrasonography of the left brachial artery.

Results: 24 patients with neovascular AMD and 26 patients with dry ADM were included in the trial. Treatment with VEGF inhibitors did not significantly change FMD (from 4.7 ± 2.4 to 3.9 ± 1.9% after 8 weeks, p = 0.07, and to 5.1 ± 2.0% after 1 year; p = 0.93 vs. baseline, respectively).

Conclusions: EF did not significantly differ between patients with neovascular AMD treated with intravitreal VEGF inhibition and patients with dry AMD.

Keywords: Age-related macular degeneration; Bevacizumab; Clinical trial; Endothelial function; Ranibizumab; Vascular endothelial growth factor.

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Figures

Fig. 1
Fig. 1
a Treatment schedule. 24-h BP, 24-h ambulatory blood pressure monitoring; BS, blood sample; VC, vascular compliance; CAP, central aortic pressure; EF, endothelial function assessed by flow-mediated dilatation; FA, fluorescein angiography; OCT, optical coherence tomography; VA, visual acuity. b CONSORT flow diagram of all patients included in the SAVE-AMD Trial.
Fig. 2
Fig. 2
a Endothelium-dependent vasodilatation in patients with anti-VEGF treatment versus control group. FMD, flow-mediated dilatation. The VEGF antagonist group comprised 23 patients (the 12-month follow-up was completed by 20 patients; a thromboembolic event occurred in 3 of these patients) and the control group (AMD) comprised 25 patients (the 12-month follow up was completed by 18 patients). b Augmentation index (AIX) in patients with anti-VEGF treatment vs. control group. The VEGF antagonist group comprised 23 patients (the 12-month follow-up was completed by 20 patients; a thromboembolic event occurred in 3 of these patients) and the control group (AMD) comprised 25 patients (the 12-month follow-up was completed by 18 patients).
Fig. 3
Fig. 3
Plasma levels of prostaglandin E2 (PGE2; a), thromboxane B2 (TBXB2; b), 15-F2t-isoprostane (8-IP; c), platelet adhesion (d), and platelet size (e) at baseline and after treatment with anti-VEGF treatment versus control group.
See this image and copyright information in PMC

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