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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
Sponsor:
Information provided by (Responsible Party):
Benedetto Falsini, Catholic University of the Sacred Heart

Tracking Information
First Submitted Date  ICMJE August 3, 2009
First Posted Date  ICMJE August 4, 2009
Last Update Posted Date August 3, 2015
Study Start Date  ICMJE June 2009
Estimated Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 3, 2009)
Focal Electroretinogram Amplitude and Phase [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 3, 2009)
Visual Acuity [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Saffron Supplementation on Macular Cone-mediated Function in Age-related Macular Degeneration
Official Title  ICMJE Effect of Saffron Supplementation on Macular Cone-mediated Function in Age-related Macular Degeneration
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).
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Age-Related Macular Degeneration
Intervention  ICMJE
  • Dietary Supplement: Saffron
    Saffron 20 mg/day supplementation
  • Dietary Supplement: Placebo
    Placebo
Study Arms  ICMJE
  • Active Comparator: Saffron
    Crocus Sativus extract
    Intervention: Dietary Supplement: Saffron
  • Placebo Comparator: Placebo
    Placebo comparator
    Intervention: Dietary Supplement: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 3, 2009)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2015
Estimated Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00951288
Other Study ID Numbers  ICMJE SafAMD
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Benedetto Falsini, Catholic University of the Sacred Heart
Study Sponsor  ICMJE Catholic University of the Sacred Heart
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Benedetto Falsini, M.D. Catholic University, Italy
PRS Account Catholic University of the Sacred Heart
Verification Date July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP