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

Catholic University of the Sacred Heart

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Age-Related Macular Degeneration

Treatments: Dietary Supplement: Saffron; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00951288

SafAMD

Details and patient eligibility

About

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).

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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30 participants in 2 patient groups, including a placebo group

Saffron

Active Comparator group

Description:

Crocus Sativus extract

Treatment:

Dietary Supplement: Saffron

Placebo

Placebo Comparator group

Description:

Placebo comparator

Treatment:

Dietary Supplement: Placebo