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THREE-YEAR OUTCOMES IN A RANDOMIZED SINGLE-BLIND CONTROLLED TRIAL OF INTRAVITREAL RANIBIZUMAB AND ORAL SUPPLEMENTATION WITH DOCOSAHEXAENOIC ACID AND ANTIOXIDANTS FOR DIABETIC MACULAR EDEMA

Lafuente, María, MD*; Ortín, Lourdes, PhD*; Argente, María, MD*; Guindo, José, L., PhD*; López-Bernal, María, D., MD*; López-Román, Francisco, J., MD, PhD, MSc; Domingo, Joan, Carles, PhD; Lajara, Jerónimo, MD*,†

doi: 10.1097/IAE.0000000000002114
Original Study: PDF Only

Purpose: To report 3-year results of a randomized single-blind controlled trial of intravitreal ranibizumab combined with oral docosahexaenoic acid (DHA) supplementation versus ranibizumab alone in patients with diabetic macular edema.

Methods: There were 26 patients (31 eyes) in the DHA group and 29 (38 eyes) in the control group. Ranibizumab (0.5 mg) was administered monthly for the first 4 months followed by a pro re nata (PRN) regimen. In the experimental group, patients received oral DHA supplementation (1,050 mg/day) (Brudyretina 1.5 g).

Results: At 36 months, mean decrease of central subfield macular thickness was higher in the DHA-supplementation group than in controls (275 ± 50 μm vs. 310 ± 97 μm) with significant differences at Months 25, 30, 33, and 34. Between-group differences in best-corrected visual acuity were not found, but the percentages of ETRDS gains >5 and >10 letters were higher in the DHA-supplementation group. Differences serum HbA1c, plasma total antioxidant capacity values, erythrocyte DHA content, and serum IL-6 levels were all significant in favor of the DHA-supplementation group.

Conclusion: The addition of a high-rich DHA dietary supplement to intravitreal ranibizumab was effective to achieve better sustained improvement of central subfield macular thickness outcomes after 3 years of follow-up as compared with intravitreal ranibizumab alone.

This is an open access article distributed under the Creative Commons Attribution License 4.0 (CCBY), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

*Department of Ophthalmology, Hospital Universitario Morales Meseguer, Murcia, Spain;

Faculty of Health Sciences, San Antonio Catholic University of Murcia, Murcia, Spain; and

Department of Biochemistry and Molecular Biology, Faculty of Biology, University of Barcelona, Barcelona, Spain.

Reprint requests: María Lafuente, MD, Department of Ophthalmology, Hospital Universitario Morales Meseguer, Avenida Marqués de los Vélez s/n, E-30008 Murcia, Spain; e-mail: marialafuentelh@gmail.com

Supported by “Fundación para la Formación e Investigación Sanitarias de la Región de Murcia” with the collaboration of Brudy Technology, S.L., and Novartis Farmacéutica, S.A.

None of the authors has conflicting interests to disclose.

© 2018 by Ophthalmic Communications Society, Inc.