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

Abstract

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.

Fig. 1.

Flowchart of the study patients and eyes.

Fig. 2.

A. Changes of CSMT from the baseline to 36 months after treatment with DHA supplementation as compared with controls (asterisk indicates statistically significant differences P < 0.05) (DHA-supplementation group: black line; control group: gray line). B. Changes in ETDRS BCVA letters in the DHA-supplementation group and in controls (DHA-supplementation group: black line; control group: gray line).

Fig. 3.

A. Increases in TAC in the two study groups (basal: black bar; 12 months: gray bar; 24 months: dark gray bar; 36 months: light gray bar). B. Changes of serum IL-6 levels in the experimental (DHA supplementation) and control groups (basal: black bar; 36 months: gray bar).