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

This study is currently recruiting participants.
Verified February 2013 by Catholic University of the Sacred Heart
Sponsor:
Information provided by (Responsible Party):
Benedetto Falsini, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier:
NCT00951288
First received: August 3, 2009
Last updated: February 11, 2013
Last verified: February 2013
History of Changes
  Purpose

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 Intervention Phase
Age-Related Macular Degeneration
 Dietary Supplement: Saffron
Dietary Supplement: Placebo
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Saffron Supplementation on Macular Cone-mediated Function in Age-related Macular Degeneration

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Catholic University of the Sacred Heart:

Primary Outcome Measures:
  • Focal Electroretinogram Amplitude and Phase [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Visual Acuity [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: June 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Saffron
Crocus Sativus extract
 Dietary Supplement: Saffron
Saffron 20 mg/day supplementation
Other Name: Saffron
Placebo Comparator: Placebo
Placebo comparator
 Dietary Supplement: Placebo
Placebo
Other Name: Placebo

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.

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00951288

Contacts
Contact: Benedetto Falsini, M.D. 063015 ext 4929 bfalsini@rm.unicatt.it

Locations
Italy
Policlinico A. Gemelli, Institute of Ophthalmology Recruiting
Rome, Italy, 00168
Contact: Benedetto Falsini, M.D.     063015 ext 4929     bfalsini@rm.unicatt.it    
Principal Investigator: Benedetto Falsini, M.D.            
Principal Investigator: Marco Piccardi, M.D.            
Sub-Investigator: Silvia Bisti, M.D.            
Sponsors and Collaborators
Catholic University of the Sacred Heart
Investigators
Principal Investigator: Benedetto Falsini, M.D. Catholic University, Italy
  More Information

Publications:

Responsible Party: Benedetto Falsini, Associate Professor, Ophthalmology, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier: NCT00951288     History of Changes
Other Study ID Numbers: SafAMD
Study First Received: August 3, 2009
Last Updated: February 11, 2013
Health Authority: Italy: Ministry of Health

Keywords provided by Catholic University of the Sacred Heart:
AMD
Retinal Function
Neuroprotection

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 23, 2013