Saffron Supplementation in Stargardt's Disease (STARSAF02)
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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 |
- 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.
- 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: | May 2013 |
| Estimated Primary Completion Date: | February 2013 (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 |
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| Contact: Benedetto Falsini, MD | 0039063015 ext 4929 | bfalsini@rm.unicatt.it |
| 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 | |
| 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: | February 11, 2013 |
| 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 May 19, 2013