Effect of Micronutrient Supplementation on the Intestinal Microbiota in Patients With Age-related Macular Degeneration - The Gut-Retina-axis Study

NACompletedINTERVENTIONAL
Enrollment

45

Participants

Timeline

Start Date

March 1, 2021

Primary Completion Date

March 1, 2022

Study Completion Date

May 1, 2024

Conditions
Age-Related Macular Degeneration
Interventions
DIETARY_SUPPLEMENT

a micronutrient mix containing lutein (10 mg), zeaxanthin (2 mg), saffron (20 mg), vitamin C (80 mg), vitamin E (12 mg) and zinc (10mg)

In this three-arm randomized, controlled trial, with one arm represented by healthy subjects, eligible participants were randomly divided into two groups. Fifteen patients were randomly allocated to the intervention group and received, for 6 months, intravitreal injections of anti-VEGF (Aflibercept 2 mg, 0.05 ml) at a fixed regimen and daily supplementation with a micronutrient mix containing lutein (10 mg), zeaxanthin (2 mg), saffron (20 mg), vitamin C (80 mg), vitamin E (12 mg) and zinc (10mg). The other fifteen patients was assigned to the control group and only received the intravitreal anti-VEGF treatment at a fixed regimen for 6 months

DRUG

anti-VEGF treatment

Intravitreal injections of anti-VEGF (Aflibercept 2 mg, 0.05 ml) at a fixed regimen for six months

Trial Locations (1)

50134

Unit of Clinical Nutrition, University Hospital of Careggi, Florence

All Listed Sponsors
collaborator

Azienda USL Toscana Centro

OTHER

lead

Azienda Ospedaliero-Universitaria Careggi

OTHER

NCT06391411 - Effect of Micronutrient Supplementation on the Intestinal Microbiota in Patients With Age-related Macular Degeneration - The Gut-Retina-axis Study | Biotech Hunter | Biotech Hunter