Genetic Disease Clinical Trial
— STARSAF02Official title:
A Novel Therapeutic Strategy Targeting Photoreceptor Oxidative Damage in ABCR-related Retinal Degenerations
Verified date | July 2017 |
Source | Catholic University of the Sacred Heart |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 30 |
Est. completion date | December 2017 |
Est. primary completion date | November 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 8 Years to 60 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Italy | Policlinico A. Gemelli | Rome |
Lead Sponsor | Collaborator |
---|---|
Catholic University of the Sacred Heart |
Italy,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Psychophysical recovery of cone system sensitivity after bleaching | 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. | six months |
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