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Randomized Controlled Trial
. 2021 Apr 10;13(4):1253.
doi: 10.3390/nu13041253.

A Randomized Study of Nutritional Supplementation in Patients with Unilateral Wet Age-Related Macular Degeneration

Alfredo García-Layana  1   2   3 , Sergio Recalde  1   2   3 , Maria Hernandez  1   2   3 , Maximino J Abraldes  3   4 , João Nascimento  5 , Emiliano Hernández-Galilea  6 , Begoña Olmedilla-Alonso  7 , Jose Juan Escobar-Barranco  8 , Miguel Angel Zapata  9 , Rufino Silva  10   11   12 , Mariana Caballero Arredondo  13 , María Carmen Lopez-Sabater  13 , Silvia Mendez-Martínez  14   15 , Nieves Pardiñas-Barón  14   15 , Pilar Calvo  14   15 , Patricia Fernández-Robredo  1   2   3
Affiliations
Randomized Controlled Trial

A Randomized Study of Nutritional Supplementation in Patients with Unilateral Wet Age-Related Macular Degeneration

Alfredo García-Layana et al. Nutrients. .

Abstract

The purpose of this study is evaluate the efficacy and safety of medicinal products containing the original Age-Related Eye Disease group (AREDS) formulation at doses approved in Europe (EU, control group; n = 59) with a product that adds DHA, lutein, zeaxanthin, resveratrol and hydroxytyrosol to the formula (intervention group; n = 50). This was a multicenter, randomized, observer-blinded trial conducted in patients aged 50 years or older diagnosed with unilateral exudative Age related Macular Degeneration AMD. At month 12, the intervention did not have a significant differential effect on visual acuity compared with the control group, with an estimated treatment difference in Early Treatment Diabetic Retinopathy Study (ETDRS) of -1.63 (95% CI -0.83 to 4.09; p = 0.192). The intervention exhibited a significant and, in most cases, relevant effect in terms of a reduction in some inflammatory cytokines and a greater improvement in the fatty acid profile and serum lutein and zeaxantin concentration. In patients with unilateral wet AMD, the addition of lutein, zeaxanthin, resveratrol, hydroxytyrosol and DHA to the AREDS EU recommended doses in the short-term did not have a differential effect on visual acuity compared to a standard AREDS EU formula but, in addition to improving the fatty acid profile and increasing carotenoid serum levels, may provide a beneficial effect in improving the proinflammatory and proangiogenic profile of patients with AMD.

Keywords: AREDS; Retilut®; Theavit®; age-related macular degeneration; angiogenic factors at month 12; carotenoids; inflammatory markers; polyunsaturated fatty acids.

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Conflict of interest statement

A.G.-L. has received consultant fees from Allergan, Bayer, Novartis, Roche, and Thea. S.R. declares no conflicts of interest. P.F.-R. declares no conflicts of interest. M.H. declares no conflicts of interest. M.J.A. has received consultant fees from Allergan, Bayer, Brill, Novartis, and Roche. J.N. has received consultant fees from Allergan, Novartis, and Zeiss. E.H.-G. declares no conflicts of interest. B.O.-A. declares no conflicts of interest. J.J.E.-B. has acted as the principal investigator in clinical trials from Roche, Novartis, and Kodiak. M.A.Z. declares no conflicts of interest. R.S. has received consultant fees from Allergan, Alimera, Bayer, Novartis, Roche, Thea, and NovoKordisk. M.C.A. declares no conflicts of interest. M.C.L.-S. declares no conflicts of interest. S.M.-M. declares no conflicts of interest. N.P.-B. declares no conflicts of interest. P.C. is a member of the advisory boards of Novartis and Bayer and a speaker for Novartis and Thea.

Figures

Figure 1
Figure 1
(a–k). Inflammatory markers and angiogenic factors at month 12. CI, confidence interval; ETD, estimated treatment difference; ES, effect size (Cohen’s d). Figures between brackets are standard deviations. * p < 0.01 vs. baseline; ** p < 0.001 vs. baseline.
Figure 1
Figure 1
(a–k). Inflammatory markers and angiogenic factors at month 12. CI, confidence interval; ETD, estimated treatment difference; ES, effect size (Cohen’s d). Figures between brackets are standard deviations. * p < 0.01 vs. baseline; ** p < 0.001 vs. baseline.
Figure 1
Figure 1
(a–k). Inflammatory markers and angiogenic factors at month 12. CI, confidence interval; ETD, estimated treatment difference; ES, effect size (Cohen’s d). Figures between brackets are standard deviations. * p < 0.01 vs. baseline; ** p < 0.001 vs. baseline.
Figure 1
Figure 1
(a–k). Inflammatory markers and angiogenic factors at month 12. CI, confidence interval; ETD, estimated treatment difference; ES, effect size (Cohen’s d). Figures between brackets are standard deviations. * p < 0.01 vs. baseline; ** p < 0.001 vs. baseline.
See this image and copyright information in PMC

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