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

Phase 1

• Conditions: Age-Related Macular Degeneration
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Saffron

• Registration Number: NCT00951288
• Lead Sponsor: 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).

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 Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-08-03
• Study First Submitted QC: 2009-08-03
• Study First Posted: 2009-08-04
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-31
• Last Update Posted: 2015-08-03
• Primary Completion: 2015-11
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo comparator
Saffron	Saffron	Crocus Sativus extract

Primary Outcome Measures

Name	Time	Method
Focal Electroretinogram Amplitude and Phase	6 months

Secondary Outcome Measures

Name	Time	Method
Visual Acuity	6 months

Trial Locations

Locations (1)

Policlinico A. Gemelli, Institute of Ophthalmology; 🇮🇹 Rome, Italy