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

July 31, 2015 updated by: Benedetto Falsini, Catholic University of the Sacred Heart
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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00168
        • Policlinico A. Gemelli, Institute of Ophthalmology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

51 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo comparator
Dietary supplement: Placebo
Placebo
Active Comparator: Saffron
Crocus Sativus extract
Dietary supplement: Saffron
Saffron 20 mg/day supplementation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Focal Electroretinogram Amplitude and Phase
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Visual Acuity
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Catholic University of the Sacred Heart

Investigators

  • Principal Investigator: Benedetto Falsini, M.D., Catholic University, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Anticipated)

November 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

August 3, 2009

First Submitted That Met QC Criteria

August 3, 2009

First Posted (Estimate)

August 4, 2009

Study Record Updates

Last Update Posted (Estimate)

August 3, 2015

Last Update Submitted That Met QC Criteria

July 31, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SafAMD

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe