Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000729820
Ethics application status
Approved
Date submitted
5/07/2012
Date registered
9/07/2012
Date last updated
19/07/2019
Date data sharing statement initially provided
19/07/2019
Date results information initially provided
19/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of saffron supplementation on vision in patients with early dry age-related macular degeneration
Scientific title
Patients with atrophic age-related macular degeneration and the effect of saffron supplementation compared with placebo in improving visual and electrophysiological outcomes
Secondary ID [1] 280731 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Age-related macular degeneration 286779 0
Condition category
Condition code
Eye 287089 287089 0 0
Diseases / disorders of the eye
Alternative and Complementary Medicine 287170 287170 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Oral Saffron supplementation with 20 mg daily for a 3 month period with possible time period extension based on results.
There is no wash out period.
Intervention code [1] 285230 0
Treatment: Other
Comparator / control treatment
Placebo treatment with a gelatin capsule daily
Control group
Placebo

Outcomes
Primary outcome [1] 287411 0
Visual Function as assessed by ETDRS visual acuity
Timepoint [1] 287411 0
visual acuity will be assessed monthly for 6 months using a standardised ETDRS (early treatment of diabetic retinopathy study) visual acuity chart
Primary outcome [2] 287412 0
Visual Function as assessed by multifocal electroretinogram findings
Timepoint [2] 287412 0
Multifocal electroretinography will be performed at baseline, 3 and 6 month data points
Primary outcome [3] 287413 0
Visual Function as assessed by flicker frequency microperimetry
Timepoint [3] 287413 0
Perimetry performed at baseline, 3 and 6 month data points
Secondary outcome [1] 298090 0
Quality of life as assessed by NEI-VFQ 25
Timepoint [1] 298090 0
NEI-VFQ 25 performed at baseline, 3 and 6 month data points

Eligibility
Key inclusion criteria
Clinical diagnosis of age-related macular degeneration (AMD) as determined by a qualified retinal specialist
Ability to participate in electroretinographic examination
Minimum age
45 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Significant ocular media opacities
Other retinal disease (i.e. diabetes, glaucoma, retinal vascular disease)
Neovascular AMD
Presence of small bowel or liver disease impairing oral tablet absorption

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients with diagnosed atrophic macular degeneration will be invited to participate at the Sydney Retina Clinic & Day Surgery, Australia. All patients will be treated with either saffron (20 mg/day, oral supplementation) or placebo for a period of 3 months, and then crossed over to the alternate treatment arm for a further 3 months. allocation not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
14/07/2012
Actual
9/01/2013
Date of last participant enrolment
Anticipated
Actual
10/11/2014
Date of last data collection
Anticipated
Actual
16/05/2016
Sample size
Target
100
Accrual to date
Final
100
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 285517 0
Charities/Societies/Foundations
Name [1] 285517 0
Melbourne Lord Mayors Charitable fund (Pilot study)
Country [1] 285517 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
The University of Sydney
NSW 2006
Australia
Country
Australia
Secondary sponsor category [1] 284428 0
Charities/Societies/Foundations
Name [1] 284428 0
Save Sight Institute
Address [1] 284428 0
8 Macquaries Street
Sydney NSW 2000
Country [1] 284428 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287530 0
Sydney South West Local Health Network HREC
Ethics committee address [1] 287530 0
Research Development Office
Royal Prince Alfred Hospital
Missendon Road
Camperdown, NSW, 2050
Ethics committee country [1] 287530 0
Australia
Date submitted for ethics approval [1] 287530 0
Approval date [1] 287530 0
07/11/2012
Ethics approval number [1] 287530 0

Summary
Brief summary
Age-related macular degeneration (AMD) is a common cause of visual loss in older people, and currently treatment options for dry AMD are limited. This study will investigate whether saffron supplements are an effective treatment for dry AMD.
Trial website
Trial related presentations / publications
Broadhead G.K, Grigg J.R, McCluskey P, Hong T, Schlub T.E, Chang A.A. Saffron therapy for the treatment of mild/moderate age-related macular degeneration: a randomized clinical trial, Graefes Arch Clin Exp Ophthalmol, 2019; 257(1): 31-40.
Public notes

Contacts
Principal investigator
Name 34361 0
A/Prof Dr Andrew Chang
Address 34361 0
Sydney Retina Clinic & Day Surgery
Level 13
187 Macquarie Street
Sydney, NSW, 2000
Country 34361 0
Australia
Phone 34361 0
+61292213755
Fax 34361 0
Email 34361 0
[email protected]
Contact person for public queries
Name 17608 0
Dr Dr Geoffrey Broadhead
Address 17608 0
Sydney Retina Clinic & Day Surgery
Level 13, Park House
187 Macquarie Street
Sydney, NSW, 2000
Country 17608 0
Australia
Phone 17608 0
+61 2 9221 3755
Fax 17608 0
Email 17608 0
[email protected]
Contact person for scientific queries
Name 8536 0
Prof Professor Peter McCluskey
Address 8536 0
Save Sight Institute,
Sydney Hospital,
8 Macquarie Street,
Sydney, NSW, 2000
Country 8536 0
Australia
Phone 8536 0
+61 2 9382 7300
Fax 8536 0
Email 8536 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
AS trial predates the updated Registration Data Set there is no applicable patient consent for this at present.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Broadhead G.K, Grigg J.R, McCluskey P, Hong T, Sch... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseSaffron therapy for the treatment of mild/moderate age-related macular degeneration: a randomised clinical trial.2019https://dx.doi.org/10.1007/s00417-018-4163-x
Dimensions AISaffron therapy for the ongoing treatment of age-related macular degeneration2024https://doi.org/10.1136/bmjophth-2023-001399
N.B. These documents automatically identified may not have been verified by the study sponsor.