NCT00951288

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jun 2009

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 3, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 4, 2009

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

August 3, 2015

Status Verified

July 1, 2015

Enrollment Period

6.4 years

First QC Date

August 3, 2009

Last Update Submit

July 31, 2015

Conditions

Age-Related Macular Degeneration

Keywords

AMDRetinal FunctionNeuroprotection

Outcome Measures

Primary Outcomes (1)

  • Focal Electroretinogram Amplitude and Phase

    6 months

Secondary Outcomes (1)

  • Visual Acuity

    6 months

Study Arms (2)

Saffron

ACTIVE COMPARATOR

Crocus Sativus extract

Dietary Supplement: Saffron

Placebo

PLACEBO COMPARATOR

Placebo comparator

Dietary Supplement: Placebo

Interventions

SaffronDIETARY_SUPPLEMENT

Saffron 20 mg/day supplementation

Saffron
PlaceboDIETARY_SUPPLEMENT

Placebo

Placebo

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Policlinico A. Gemelli, Institute of Ophthalmology

Rome, 00168, Italy

Location

Related Publications (4)

  • 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.

    PMID: 18326756BACKGROUND

  • 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.

    PMID: 12511345BACKGROUND

  • 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.

    PMID: 10798669BACKGROUND

  • 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.

    PMID: 20688744RESULT

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Study Officials

  • Benedetto Falsini, M.D.

    Catholic University, Italy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Ophthalmology

Study Record Dates

First Submitted

August 3, 2009

First Posted

August 4, 2009

Study Start

June 1, 2009

Primary Completion

November 1, 2015

Study Completion

December 1, 2015

Last Updated

August 3, 2015

Record last verified: 2015-07

Locations

IT(1)