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Register:	ClinicalTrials.gov
Last refreshed on:	16 December 2017
Main ID:	NCT01278277
Date of registration:	14/01/2011
Prospective Registration:	Yes
Primary sponsor:	Catholic University of the Sacred Heart
Public title:	Saffron Supplementation in Stargardt's Disease STARSAF02
Scientific title:	A Novel Therapeutic Strategy Targeting Photoreceptor Oxidative Damage in ABCR-related Retinal Degenerations
Date of first enrolment:	February 2011
Target sample size:	30
Recruitment status:	Active, not recruiting
URL:	https://clinicaltrials.gov/show/NCT01278277
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
Phase:	Phase 1/Phase 2

Countries of recruitment
Italy

Contacts

Name:	Benedetto Falsini, MD
Address:
Telephone:
Email:
Affiliation:	Catholic University of the Sacred Heart

Name:	Silvia Bisti, PhD
Address:
Telephone:
Email:
Affiliation:	University of L'Aquila

Name:	Marco Piccardi, MD
Address:
Telephone:
Email:
Affiliation:	Catholic University of the Sacred Heart

Key inclusion & exclusion 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

Age minimum: 8 Years
Age maximum: 60 Years
Gender: All

Health Condition(s) or Problem(s) studied

Retinal Degeneration

Single-Gene Defects

Macular Dystrophy

Genetic Disease

Intervention(s)

Dietary Supplement: Saffron supplementation

Other: placebo

Primary Outcome(s)

Focal electroretinogram (FERG) [Time Frame: six months]

Secondary Outcome(s)

Psychophysical recovery of cone system sensitivity after bleaching [Time Frame: six months]

Secondary ID(s)

STARSAF02

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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