Abstract
Purpose :
To demonstrate that factor levels of the ocular and systemic complement system in patients with neovascular age-related macular degeneration (nAMD) during treatment with anti-VEGF substances are not influenced by a monthly intake of AREDS2 dietary supplementation.
Methods :
Prospective, single center, controlled, randomized, open-label investigator initiated trial (Registration DRKS00012507, https://www.drks.de). After obtaining informed consent, patients diagnosed with nAMD requiring intravitreal anti-VEGF treatment, who had not taken any dietary supplementation for nAMD during the last three months were randomized 1:1 in one of two study groups: The first group received oral dietary AREDS2 supplement for four weeks, the second had no dietary supplementation. Local and systemic complement activation in aqueous humour and blood plasma was measured via enzyme-linked immunosorbent assays (ELISA) quantifying the following proteins: C3, C3a, Ba, FH, FI, sC5b. One aqueous humour sample and two blood samples were collected per patient. The first blood sample was collected at randomization, the second blood sample as well as the aqueous humour sample were taken after 4 weeks of oral supplementation with AREDS2 at the day of the intravitreal injection.
Results :
Sixty-two patients could be enrolled in this study, whereof 50 completed the trial. In 27 patients randomized in the AREDS2 supplement group, zinc blood levels increased significantly from 9.10 mg/dl at baseline (BL) to 10.16 mg/dl at follow-up (FU, p=0.009). Zinc levels in the control group changed from 9.56 mg/dl at BL to 8.69 mg/dl at FU (p=0.038). In blood plasma, C3 and C3a as well as FH, FI and sC5b were comparable between timepoints in both groups (p>0.1). Only Ba showed a significant increase between BL and FU in all patients (p=0.01), which was higher in the control group (p=0.02) than in the AREDS2 group (p=0.23). In aqueous humour samples local complement activation was also not different between both groups (p>0.26).
Conclusions :
Four weeks of oral AREDS 2 intake leads to a significant increase in systemic zinc levels. Local and systemic complement activation during anti-VEGF treatment seems not to be influenced during anti-VEGF treatment by this dietary supplementation.
This is a 2020 ARVO Annual Meeting abstract.