Saffron Supplementation in Stargardt's Disease (STARSAF02)

This study is currently recruiting participants.
Verified January 2014 by Catholic University of the Sacred Heart
Sponsor:
Information provided by (Responsible Party):
Benedetto Falsini, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier:
NCT01278277
First received: January 14, 2011
Last updated: January 28, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Retinal Degeneration
Genetic Disease
Single-Gene Defects
Macular Dystrophy
Dietary Supplement: Saffron supplementation
Other: placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Novel Therapeutic Strategy Targeting Photoreceptor Oxidative Damage in ABCR-related Retinal Degenerations

Resource links provided by NLM:


Further study details as provided by Catholic University of the Sacred Heart:

Primary Outcome Measures:
  • Focal electroretinogram (FERG) [ Time Frame: six months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Psychophysical recovery of cone system sensitivity after bleaching [ Time Frame: six months ] [ Designated as safety issue: No ]
    Psychophysical threshold will be determined at the paracentral visual field locations with preserved visual sensitivity, by presenting a 0.5 sec flashing light on a light adapting background of 20 cd/sqm. Following baseline assessment, the threshold intensity for the flashed light will be measured and plotted as a function of time, following 30 sec exposure to an adapting light (delivered in Maxwellian view by means of a calibrated indirect ophthalmoscope) whose intensity is estimated bleach approx 30% of the cone photopigment.


Estimated Enrollment: 30
Study Start Date: February 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo supplementation
patients will be assigned, in a cross-over design, to placebo or supplement administration
Other: placebo
placebo supplementation
Active Comparator: Saffron
Saffron Supplementation 20 mg/die
Dietary Supplement: Saffron supplementation
Saffron supplementation 20 mg
Other Name: Zaffit Special

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   8 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • absence of a rod-cone pattern of dysfunction
  • acuity less than 0.1
  • Unknown genotype
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01278277

Contacts
Contact: Benedetto Falsini, MD 0039063015 ext 4929 bfalsini@rm.unicatt.it

Locations
Italy
Policlinico A. Gemelli Recruiting
Rome, Italy, 00168
Contact: Benedetto Falsini, MD    0039063015 ext 4929    bfalsini@rm.unicatt.it   
Sub-Investigator: Dario Marangoni, MD         
Principal Investigator: Benedetto Falsini, MD         
Principal Investigator: Marco Piccardi, MD         
Sponsors and Collaborators
Catholic University of the Sacred Heart
Investigators
Principal Investigator: Benedetto Falsini, MD Catholic University of the Sacred Heart
Principal Investigator: Marco Piccardi, MD Catholic University of the Sacred Heart
Study Director: Silvia Bisti, PhD University of L'Aquila
  More Information

Additional Information:
Publications:
Responsible Party: Benedetto Falsini, Associate Professor Ophthalmology, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier: NCT01278277     History of Changes
Other Study ID Numbers: STARSAF02
Study First Received: January 14, 2011
Last Updated: January 28, 2014
Health Authority: Italy: Ethics Committee

Keywords provided by Catholic University of the Sacred Heart:
Stargardt disease
macula
electroretinogram
saffron

Additional relevant MeSH terms:
Genetic Diseases, Inborn
Retinal Degeneration
Macular Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on April 21, 2014