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Effect of Saffron Supplementation on Macular Cone-mediated Function in Age-related Macular Degeneration (safAMD)

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ClinicalTrials.gov Identifier: NCT00951288
Recruitment Status : Unknown
Verified July 2015 by Benedetto Falsini, Catholic University of the Sacred Heart.
Recruitment status was:  Enrolling by invitation
First Posted : August 4, 2009
Last Update Posted : August 3, 2015
Information provided by (Responsible Party):
Benedetto Falsini, Catholic University of the Sacred Heart

Brief Summary:
This is a pilot interventional study whose aim is to determine the effect of a dietary supplementation with a Crocus Sativus extract, Saffron, on macular cone-mediated function in patients with early age-related macular degeneration (AMD). Pre-clinical evidence ( Maccarone R, Di Marco S, Bisti S. Saffron supplement maintains morphology and function after exposure to damaging light in mammalian retina. Invest Ophthalmol Vis Sci. 2008 Mar;49(3):1254-61.) indicates the potential effectiveness of Saffron as a retinal neuroprotectant in animal models of retinal degenerative disorders.The macular function will be tested by visual acuity and macular cone-mediated electroretinogram (focal electroretinogram, FERG) according to a standardized technique (see citations).

Condition or disease Intervention/treatment Phase
Age-Related Macular Degeneration Dietary Supplement: Saffron Dietary Supplement: Placebo Phase 1 Phase 2

Detailed Description:
A group of 30 AMD patients with typical lesions (drusen and/or retinal pigment epithelial defects) and relatively preserved central retinal function and visual acuity will be enrolled. AMD patients will be randomly divided into two groups: 1. placebo group [n = 15), taking for three months an oral placebo; 2. Saffron group (n = 15), taking Saffron oral treatment (20 mg/day) for three months. After three months of placebo or Saffron supplementation, patients will be tested with standard ophthalmic examination and FERGs. Then, placebo with Saffron and vice-versa will be changed to the same patients in a cross-over design. After a further three month period of placebo or study drug supplementation, patients will undergo again a standard ophthalmic examination, and FERG. Throughout the study, both patients and experimenters will be masked as to the identity of pills (i.e. whether placebo or study drug), whose identification key number will be kept in a sealed envelope that will be opened only at the completion of the study. Therapeutic compliance will be tested by careful questioning, either at two weeks of treatment (by telephone interview) or at the end of the treatment period, as well as by pill count. Main outcome measures of the study will be FERG amplitude and phase.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Saffron Supplementation on Macular Cone-mediated Function in Age-related Macular Degeneration
Study Start Date : June 2009
Estimated Primary Completion Date : November 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Saffron
Crocus Sativus extract
Dietary Supplement: Saffron
Saffron 20 mg/day supplementation

Placebo Comparator: Placebo
Placebo comparator
Dietary Supplement: Placebo

Primary Outcome Measures :
  1. Focal Electroretinogram Amplitude and Phase [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Visual Acuity [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age > 55 yrs
  • Diagnosis of Early, non exudative AMD
  • Visual acuity of 20/40 or better

Exclusion Criteria:

  • Concomitant ocular or systemic disorders which may affect macular function
  • Drugs that may affect macular function

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 ClinicalTrials.gov identifier (NCT number): NCT00951288

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Policlinico A. Gemelli, Institute of Ophthalmology
Rome, Italy, 00168
Sponsors and Collaborators
Catholic University of the Sacred Heart
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Principal Investigator: Benedetto Falsini, M.D. Catholic University, Italy
Publications of Results:
Other Publications:
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Responsible Party: Benedetto Falsini, Associate Professor, Ophthalmology, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier: NCT00951288    
Other Study ID Numbers: SafAMD
First Posted: August 4, 2009    Key Record Dates
Last Update Posted: August 3, 2015
Last Verified: July 2015
Keywords provided by Benedetto Falsini, Catholic University of the Sacred Heart:
Retinal Function
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases