Dietetic supplementation of docosahexaenoic acid (DHA) in non proliferative diabetic retinopathy

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1 Dietetic supplementation of docosahexaenoic acid (DHA) in non proliferative diabetic retinopathy A prospective controlled study of macular function using microperimetry Communication presented at XXI CONGRESS Spanish Society of Retina and Vitreous Madrid Mars MEDICAL NUTRITION SPECIALISTS

2 Dietetic supplementation of docosahexaenoic acid (DHA) in non proliferative diabetic retinopathy A prospective controlled study of macular function using microperimetry María Elena Rodríguez González-Herrero1, Marcos Ruiz1, Francisco Javier López-Román2, José María Marín Sánchez1, Juan Carlos Domingo Pedrol3 (1) Servicio de Oftalmología. Hospital Universitario Virgen de la Arrixaca, Murcia. (2) Cátedra de Fisiología del Ejercicio, Departamento de Ciencias de la Salud. Universidad Católica de Murcia, Murcia. (3) Departamento de Bioquímica y Biología Molecular, Facultad de Biología. Universitat de Barcelona, Barcelona. Objectives To evaluate the effect of a dietetic supplementation with Docosahexaenoic acid triglyceride (BrudyRetina 3 caps/day = 1.050mg DHA-TG) in 24 patients suffering non proliferative diabetic retinopathy. Methods Patients were randomized either to the supplementation group or to the control group (12 patients (24 eyes) in each group, evaluating the best-corrected visual acuity (BCVA), the central macular thickness (OCT), the macular sensitivity at 10 central degrees and the macular integrity index both with microperimetry (MAIA CentreVue), and comparing the basal situation with that after 45 and 90 days. A linear mixed model is used to compare the between groups variables at each time period (covariable: baseline measurement; random factor: the patient). Data are expressed as mean and standard deviation (SD). Results DHA concentration in red blood cell membranes was significantly increased only in the supplemented group (3.9 [0.6] vs. 5.6[0.8]% of the total fatty acids; P<0.001). Macular Thickness and BCVA had no significant changes in any of the groups. Macular sensitivity was significantly improved only in the supplemented group (from 25,9 [2,4]dB to 27,2 [2,3] db after 90 days; P<0.001; between groups comparison: P<0.19). The macular integrity index (the lower is the index, higher is the probability of having a normal macula) was significantly reduced only in the supplemented group (basal: 71,2 [33,2], at 45 days: 63,5 [36,4], at 90 days: 51,6 [35,9]; P<0.001; between groups comparison P<0.05). Total antioxidant capacity (TAC) was significantly improved in the supplemented group (121,3 [33,4] vs. 162,8 [41,0], P<0.05, between groups comparison P<0.001). Scores from the National Eye Institute-Visual Function Questionnaire (NEI-VFQ-25) to evaluate visual quality is showing a clear tendency towards improvement in the supplemented group (basal: 86,9 [9,5], 45 days: 88,2 [7,8], 90 days: 91,4 [5,3]; between groups comparison P<0.037), and a worsening tendency in the control group. Conclusions In an early phase of diabetic retinopathy, DHA-TG supplementation during 90 days progressively and significantly improved macular function measured by microperimetry.

3 Communication presented at XXI CONGRESS Spanish Society of Retina and Vitreous Madrid Mars Evaluations Basal Supplementation after 45 days Supplementation after 90 days Results Variable Basal 90 days P value % DHA in red blood cells 3,9 (0,6) 5,6 (0,8) <0,001 Variables BCVA (ETDRS) BMC and Eye fundus Retinography OCT Microperimetry Blood and Urine chemistry (basal and after 90 days) NEI-VFQ-25 visual quality questionnaire Macular function measured by microperimetry Macular sensitivity at the central 10 degress Macular Integrity Index (MAIA CenterVue): the lower is the index, higher is the probability of having a normal macula. BCVA OCT Macular thickness, µm Macular sensitivity, db Macular Integrity Index VFQ-25 Questionnaire TAC NS NS 25,9 (2,4) 27,2 (2,3) <0,001 71,2 (33,2) 51,6 (35,9) <0,001 86,9 (9,5) 91,4 (5,3) <0,05 121,3 (33,3) 162,7 (40,9) <0,001 Objective To evaluate the influence of DHA-TG supplementation (1.050mg/day; 3 caps/day of BrudyRetina) in 24 patients suffering NPDR. Randomization 12 patients (experimental group) 12 patients ( group) 48 eyes analyzed Variables Macular function by microperimetry (main variable) Visual Acuity (BCVA) Central macular thickness Statistical analysis A linear mixed model (for fixed and at random effects) to compare the between groups variables at each time period. Data expressed as mean and SD

4 After 90 days a significant improvement of the macular sensitivity is seen only in the supplemented group, when comparing with the basal situation. There are no significant changes seen in the control group, of non-supplemented patients. Macular Sensitivity (db) Between groups differences P<0.19 Basal 45 days 90 days Significant improvement in the macular integrity index of the supplemented group after 45 and 90 days is seen when compared with that of the non-supplemented control group. Significant between groups differences are also seen. Significant differences in BCVA and central macular thickness (OCT) can t be detected in any of the groups. Macular Integrity Index (%) Between groups differences P<0.001 Basal 45 days 90 days DHA concentration in the red blood cell membrane is significantly increased only in the supplemented group when comparing the basal situation with the final situation after 90 days. Significant between groups differences are also seen. DHA (Total % of fatty acids) Between groups differences P< Basal 3 months

Communication presented at XXI CONGRESS Spanish Society of Retina and Vitreous Madrid 2017 3-4 Mars p < 0.

5 Communication presented at XXI CONGRESS Spanish Society of Retina and Vitreous Madrid Mars p < A significant improvement of the serum total antioxidant capacity in the supplemented group is seen. No changes can be detected in the control group. There are significant between groups differences. TAC (copper reducing equivalents μm) Between groups differences P<0.05 Basal 3 months National Eye Institute Visual Function Questionnaire (NEI-VFQ) to measure the self-reported quality and visual defects of patients suffering chronic eye pathology. While the supplemented group tends to an improvement in the scoring, the control group tends to a worsening. There are between groups differences. NEI-VFQ-25 Scoring Between groups differences P<0.037 Basal 45 days 90 days

Conclusions In an early phase of diabetic retinopathy, DHA-TG supplementation during 90 days progressively and significantly improved macular function measured by microperimetry.

6 Conclusions In an early phase of diabetic retinopathy, DHA-TG supplementation during 90 days progressively and significantly improved macular function measured by microperimetry. No changes observed in BCVA and OCT can result from a to short follow-up period. These positive preliminary results are suggesting that a new randomized placebo controlled and double-blinded clinical trial could be designed to confirm the results. Should these results be confirmed, it opens a new expectative of a preventive treatment for diabetic patients suffering an early phase of retinopathy. This possibility would be clinically relevant, and possibly cost efficient. BRUD Y MÁCULA BRUD Y RETINA COMPOSITION In 1 capsule %RDA* Oil concentrated in Omega-3 fatty acids 22:6ω3, DHA (mg) :5ω3, EPA (mg) 42,5-22:5ω3, DPA (mg) 30 - Vitamins Vitamin C (mg) Vitamin E (mg α-et) Minerals Zinc (mg) Copper (mg) Other nutrients Lutein(mg) 5 - Zeaxanthin (mg) 1,4 - *RDA = Recommended daily allowances 1 capsule/day = 350 mg DHA COMPOSITION 1 cap. %RDA* 3 cap. %RDA* Oil concentrated in Omega-3 fatty acids 22:6ω3, DHA (mg) :5ω3, EPA (mg) 42, :5ω3, DPA (mg) Vitamins Vitamin B1 (mg) 0, ,1 100 Vitamin B2 (mg) 0, ,4 100 Vitamin B3 (mgne) 5, Vitamin B6 (mg) 0, ,4 100 Vitamin B9 (µg) 66, Vitamin B12 (µg) 0, ,5 100 Vitamin C (mg) 26, Vitamin E (mg α-te) Minerals Zinc (mg) 1,66 16, Copper (mg) 0,16 16,66 0,5 50 Selenium (µg) 9,16 16,66 27,5 50 Manganese (mg) 0,33 16, Other nutrients Lutein (mg) Zeaxanthin (mg) 0,3-0,9 - Glutathione (mg) capsules/day = 1050 mg DHA BRUDYLAB Riera de Sant Miquel, 3 2º 4ª Barcelona. Tel The information content is exclusively addressed to healthcare professionals

Intravitreal ranibizumab combined with oral suplementation with docosahexaenoic acid and antioxidants in diabetic macular edema

Intravitreal ranibizumab combined with oral suplementation with docosahexaenoic acid and antioxidants in diabetic macular edema Results at 36 months of a controlled, randomized, simple blinded clinical