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

NCT ID: NCT00951288

Last Updated: 2015-08-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2015-12-31

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.

Conditions

Age-Related Macular Degeneration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Saffron

Crocus Sativus extract

Group Type: ACTIVE_COMPARATOR

Saffron

Intervention Type: DIETARY_SUPPLEMENT

Saffron 20 mg/day supplementation

Placebo

Placebo comparator

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Interventions

Saffron

Saffron 20 mg/day supplementation

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Catholic University of the Sacred Heart

OTHER

Sponsor Role: lead

Responsible Party

Benedetto Falsini

Associate Professor, Ophthalmology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Benedetto Falsini, M.D.

Role: PRINCIPAL_INVESTIGATOR

Catholic University, Italy

Locations

Policlinico A. Gemelli, Institute of Ophthalmology

Rome, , Italy

Countries

Italy

References

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. doi: 10.1167/iovs.07-0438.

Reference Type: BACKGROUND

PMID: 18326756 (View on PubMed)

Falsini B, Piccardi M, Iarossi G, Fadda A, Merendino E, Valentini P. Influence of short-term antioxidant supplementation on macular function in age-related maculopathy: a pilot study including electrophysiologic assessment. Ophthalmology. 2003 Jan;110(1):51-60; discussion 61. doi: 10.1016/s0161-6420(02)01547-6.

Reference Type: BACKGROUND

PMID: 12511345 (View on PubMed)

Falsini B, Fadda A, Iarossi G, Piccardi M, Canu D, Minnella A, Serrao S, Scullica L. Retinal sensitivity to flicker modulation: reduced by early age-related maculopathy. Invest Ophthalmol Vis Sci. 2000 May;41(6):1498-506.

Reference Type: BACKGROUND

PMID: 10798669 (View on PubMed)

Falsini B, Piccardi M, Minnella A, Savastano C, Capoluongo E, Fadda A, Balestrazzi E, Maccarone R, Bisti S. Influence of saffron supplementation on retinal flicker sensitivity in early age-related macular degeneration. Invest Ophthalmol Vis Sci. 2010 Dec;51(12):6118-24. doi: 10.1167/iovs.09-4995. Epub 2010 Aug 4.

Reference Type: RESULT

PMID: 20688744 (View on PubMed)

Other Identifiers

SafAMD

Identifier Type: -

Identifier Source: org_study_id