Saffron Supplementation in Stargardt's Disease

Summary

The general area of research in which this project has been designed is that of retinal degeneration related to mutations in the ABCR gene, responsible of Stargardt disease/fundus flavimaculatus retinal dystrophy (STD/FF). STG/FF is one of the major causes of vision impairment in the young age. STG/FF originates typically from the dysfunction and loss of cone and rod photoreceptors, developing through a photo-oxidative mechanism. The major disease locus is the central retina, i.e. the macula, whose neurons have the highest density and underlie critical functions such as visual acuity, color vision and contrast sensitivity. There is currently no cure for STG/FF. Recent experimental findings indicate that Saffron, derived from the pistils of Crocus Sativus, may have a role as a retinal neuro-protectant against oxidative damage. The stigmata of Crocus sativus contain biologically high concentrations of chemical compounds including crocin, crocetin, whose multiple C=C bonds provide the antioxidant potential. In addition it is well known that this compound is safe and free of adverse side effects. The aim of this research is to investigate the influence of short-term Saffron supplementation on retinal function in STG/FF patients carrying ABCR mutations. The macular cone-mediated electroretinogram (ERG) in response to high-frequency flicker (focal flicker ERG) will be employed as the main outcome variable. Secondary outcome variable will be the psychophysical cone system recovery after bleaching.

Conditions

• Retinal Degeneration
• Genetic Disease
• Single-Gene Defects
• Macular Dystrophy

Interventions

DIETARY_SUPPLEMENT

Saffron supplementation

Saffron supplementation 20 mg

OTHER

placebo

placebo supplementation

Sponsors & Collaborators

• Catholic University of the Sacred Heart

  lead OTHER

Principal Investigators

• Benedetto Falsini, MD · Catholic University of the Sacred Heart

• Marco Piccardi, MD · Catholic University of the Sacred Heart

• Silvia Bisti, PhD · University of L'Aquila

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

8 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-02-28

Primary Completion

2017-11-30

Completion

2017-12-31

Countries

• Italy

Study Locations