Saffron Supplementation in Stargardt's Disease

NCT01278277 | Unknown Phase 1

• 1 other identifier: STARSAF02
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Stargardt disease; macula; electroretinogram; saffron

Outcome Measures

Primary Outcomes (1)

• Focal electroretinogram (FERG)

  ERGs will be elicited by the LED-generated sinusoidal luminance modulation of a circular uniform field (18° in diameter, 80 cd/m2 mean luminance, dominant wavelength: 630 nm), presented at the frequency of 41 Hz on the rear of a ganzfeld bowl, illuminated at the same mean luminance as the stimulus.

  six months

Secondary Outcomes (1)

• Psychophysical recovery of cone system sensitivity after bleaching

  six months

Study Arms (2)

placebo supplementation

PLACEBO COMPARATOR

patients will be assigned, in a cross-over design, to placebo or supplement administration

Other: placebo

Saffron

ACTIVE COMPARATOR

Saffron Supplementation 20 mg/die

Dietary Supplement: Saffron supplementation

Interventions

Saffron supplementation DIETARY_SUPPLEMENT

Saffron supplementation 20 mg

Also known as: Zaffit Special

Saffron

placebo OTHER

placebo supplementation

placebo supplementation

Eligibility Criteria

• Age: 8 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Macular and peripheral retinal degeneration with typical funduscopic lesions (retinal flecks)
• Relatively preserved central retinal function
• Known genotype or genotype under study

You may not qualify if:

• absence of a rod-cone pattern of dysfunction
• acuity less than 0.1
• Unknown genotype

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead

Study Sites (1)

Policlinico A. Gemelli

Rome, 00168, Italy

Location

Related Publications (2)

• Falsini B, Piccardi M, Minnella A, Savastano C, Capoluongo E, Fadda A, Balestrazzi E, Maccarone R, Bisti S. Influence of saffron supplementation on retinal flicker sensitivity in early age-related macular degeneration. Invest Ophthalmol Vis Sci. 2010 Dec;51(12):6118-24. doi: 10.1167/iovs.09-4995. Epub 2010 Aug 4.

  PMID: 20688744 BACKGROUND

• Piccardi M, Fadda A, Martelli F, Marangoni D, Magli A, Minnella AM, Bertelli M, Di Marco S, Bisti S, Falsini B. Antioxidant Saffron and Central Retinal Function in ABCA4-Related Stargardt Macular Dystrophy. Nutrients. 2019 Oct 15;11(10):2461. doi: 10.3390/nu11102461.

  PMID: 31618812 DERIVED

MeSH Terms

Conditions

Retinal Degeneration; Genetic Diseases, Inborn; Macular Degeneration; Stargardt Disease

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Retinal Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Benedetto Falsini, MD

  Catholic University of the Sacred Heart

  PRINCIPAL INVESTIGATOR

• Marco Piccardi, MD

  Catholic University of the Sacred Heart

  PRINCIPAL INVESTIGATOR

• Silvia Bisti, PhD

  University of L'Aquila

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Ophthalmology

Study Record Dates

• First Submitted: January 14, 2011
• First Posted: January 17, 2011
• Study Start: February 1, 2011
• Primary Completion: November 1, 2017
• Study Completion: December 1, 2017
• Last Updated: July 19, 2017

Record last verified: 2017-07

Locations

IT (1)