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临床试验/NCT00951288
NCT00951288Unknown1 期

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

Catholic University of the Sacred Heart1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2009年6月1日最近更新:
适应症
干预措施

试验速览

阶段
1 期
入组人数
30
试验地点
1
主要终点
Focal Electroretinogram Amplitude and Phase

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
55 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age > 55 yrs
  • •Diagnosis of Early, non exudative AMD
  • •Visual acuity of 20/40 or better

排除标准

  • •Concomitant ocular or systemic disorders which may affect macular function
  • •Drugs that may affect macular function

研究组 & 干预措施

Saffron

Active Comparator

Crocus Sativus extract

干预措施: Saffron (Dietary Supplement)

Placebo

Placebo Comparator

Placebo comparator

干预措施: Placebo (Dietary Supplement)

结局指标

主要结局

Focal Electroretinogram Amplitude and Phase

时间窗: 6 months

次要结局

  • Visual Acuity(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Benedetto Falsini

Associate Professor, Ophthalmology

Catholic University of the Sacred Heart

研究点 (1)

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