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Saffron Supplementation in Stargardt's Disease (STARSAF02)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01278277
Recruitment Status : Unknown
Verified July 2017 by Benedetto Falsini, Catholic University of the Sacred Heart.
Recruitment status was:  Active, not recruiting
First Posted : January 17, 2011
Last Update Posted : July 19, 2017
Information provided by (Responsible Party):
Benedetto Falsini, Catholic University of the Sacred Heart

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.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Novel Therapeutic Strategy Targeting Photoreceptor Oxidative Damage in ABCR-related Retinal Degenerations
Study Start Date : February 2011
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : December 2017

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Focal electroretinogram (FERG) [ Time Frame: six months ]
    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 :
  1. Psychophysical recovery of cone system sensitivity after bleaching [ Time Frame: six months ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01278277

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Policlinico A. Gemelli
Rome, Italy, 00168
Sponsors and Collaborators
Catholic University of the Sacred Heart
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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
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Benedetto Falsini, Associate Professor Ophthalmology, Catholic University of the Sacred Heart Identifier: NCT01278277    
Other Study ID Numbers: STARSAF02
First Posted: January 17, 2011    Key Record Dates
Last Update Posted: July 19, 2017
Last Verified: July 2017
Keywords provided by Benedetto Falsini, Catholic University of the Sacred Heart:
Stargardt disease
Additional relevant MeSH terms:
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Retinal Degeneration
Stargardt Disease
Macular Degeneration
Genetic Diseases, Inborn
Eye Diseases, Hereditary
Eye Diseases
Retinal Diseases