The aim of this double blind clinical trial is to assess the electroretinography(ERG) changes in patients with age-related macular degeneration (AMD) after supplemental saffron consumption. This trial will be conducted in Farabi hospital and a total number of 80 eyes will be studied. Patients suffering from AMD will be recruited and then ERG, fluorescein angiography (FA), and ocular coherence tomography (OCT) will be performed for each patient. Based on FA interpretations, patients will be divided into two groups: wet (neovascular) or dry (non-neovascular). Dry subtype patients will be randomized to the saffron or the control group by a third person who is completely blind to the patients’ information. Dry subtype patients will receive two capsules (saffron or placebo) per day for six months and will undergo ERG and OCT by months 3 and 6. Wet subtype patients will be randomized to the saffron or the control group in the same manner and will receive the same medications. Each saffron capsule contains 15mg of hydro-alcoholic saffron. Placebo capsules are identical in appearance to saffron and are dispensed by the investigational drug pharmacist. Intravitreal bevacizumab (IVB) will be injected for wet subtype patients monthly for three times. Inclusion criteria: visual acuity: 20/40 >⋯ > 20/400; no prior treatment for AMD definite diagnosis. Exclusion criteria: any concurrent ocular disease (e.g. diabetic retinopathy, retinal vascular disease); history of keratoconus history of glaucoma. Changes by months 3 and 6 will be compared to the baseline and the efficacy of this treatment will be analyzed by statistical methods.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201205219820N1
Registration date:2012-09-30, 1391/07/09
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-09-30, 1391/07/09
Registrant information
Name
Alireza Lashay
Name of organization / entity
Eye research center
Country
Iran (Islamic Republic of)
Phone
+98 21 5512 1002
Email address
lashay@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Eye Research Center, Tehran University of Medical Sciences
Expected recruitment start date
2011-03-20, 1389/12/29
Expected recruitment end date
2012-03-19, 1390/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Efficacy of Supplemental Saffron in Patients with Age-Related Macular Degeneration
Public title
The Efficacy of Supplemental Saffron in Patients with Age-Related Macular Degeneration
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: visual acuity: 20/40 >⋯ > 20/400; being available; no prior treatment for AMD; definite diagnosis; being between the study range of age. Exclusion criteria: any concurrent ocular disease (e.g. diabetic retinopathy, retinal vascular disease); history of keratoconus; history of glaucoma.
Age
From 50 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Enghelab Square
City
Tehran
Postal code
Approval date
2011-06-20, 1390/03/30
Ethics committee reference number
3216/210/ص/90
Health conditions studied
1
Description of health condition studied
Age-related macular degeneration
ICD-10 code
H35.3
ICD-10 code description
Degeneration of macula and posterior pole
Primary outcomes
1
Description
ERG
Timepoint
START STUDY.3MONTH.6MONTH
Method of measurement
Amplitude and implicite time
2
Description
OCT
Timepoint
at the beginning, month 3 and month 6
Method of measurement
Thickness
Secondary outcomes
1
Description
OCT
Timepoint
3 month
Method of measurement
thickness
Intervention groups
1
Description
saffron capsule 15mg, bid, for 6 month
Category
Treatment - Drugs
2
Description
placebo tablet, bid, for 6 month
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Farabi Eye Hospital
Full name of responsible person
Dr. Sadough
Street address
Farabi Eye Hospital
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Eye Research center
Full name of responsible person
Dr. lashay
Street address
Qazvin Square, Farabi Eye Hospital
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Eye Research center
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Farabi Eye Hospital
Full name of responsible person
Dr. Gholamreza Sadough
Position
resident
Other areas of specialty/work
Street address
Farabi Eye Hospital
City
Tehran
Postal code
Phone
+98 21 5541 6134
Fax
Email
r_sadough@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Farabi Eye Hospital
Full name of responsible person
Dr. Alireza Lashay
Position
professor
Other areas of specialty/work
Street address
Farabi Eye Hospital
City
Tehran
Postal code
Phone
+98 21 5542 4261
Fax
Email
lashay@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)