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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000004804
Receipt No. R000005712
Scientific Title Randomized, three-group, parallel comparative study on changes in macular pigment optical density and visual function due to administration of supplements containing lutein and omega3 fatty acids to patients with age-related macular degeneration (patients treated with ranibizumab)
Date of disclosure of the study information 2010/12/28
Last modified on 2012/05/21

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Basic information
Public title Randomized, three-group, parallel comparative study on changes in macular pigment optical density and visual function due to administration of supplements containing lutein and omega3 fatty acids to patients with age-related macular degeneration (patients treated with ranibizumab)
Acronym The comparative study on the effects of lutein and omega3 fatty acids supplements to age-related macular degeneration
Scientific Title Randomized, three-group, parallel comparative study on changes in macular pigment optical density and visual function due to administration of supplements containing lutein and omega3 fatty acids to patients with age-related macular degeneration (patients treated with ranibizumab)
Scientific Title:Acronym The comparative study on the effects of lutein and omega3 fatty acids supplements to age-related macular degeneration
Region
Japan

Condition
Condition age-related macular degeneration
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To investigate macular pigment density and visual function in patients with age-related macular degeneration (treated with ranibizumab), who are taking a supplement containing lutein, lutein plus omega3 fatty acids, or multivitamins and minerals, for 1 year. Frequency of retreatment with intravitreal ranibizumab will also be investigated.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Macular pigment optical density
Key secondary outcomes (1)Frequency of retreatment with intravitreal ranibizumab
(2)Ophthalmological evaluations
Essential: Visual acuity (using an ETDRS visual acuity chart), slit-lamp microscopy and funduscopy under mydriasis, color fundus photography, fluorescein and indocyanine green angiography, central retinal thickness as measured by optical coherence tomography (OCT-3000)
Optional: Measurement of contrast sensitivity, measurement of glare sensitivity, Humphrey field analyzer (10-2), M-chart
(3)Plasma lutein,DHA concentration

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 multivitamins and minerals (M&M)
Interventions/Control_2 multivitamins and minerals plus a lutein supplement (M&M + lutein)
Interventions/Control_3 multivitamins and minerals plus supplements containing lutein + omega3 fatty acids (M&M + lutein + omega3)
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
50 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1)Exudative age-related macular degeneration with subfoveal choroidal neovascularization. However, eyes with retinal angiomatous proliferation (RAP) will be excluded
(2)Eyes with improvement in exudative changes after receiving 3 injections of intravitreal ranibizumab (Lucentis)
Improvement is defined as a decrease in central retinal thickness by at least 100um (as measured by OCT-3000).
(3)Start of the study within 1-2 months of the last injection of intravitreal ranibizumab
(4)Visual Acuity is more than 50 ETDRS letters (0.2)
(5)Aged 50 years or older at provision of informed consent, and has given consent in writing
(6)Male or female
(7)Judged by the investigator to be eligible as a subject on the basis of screening tests
(8)Not allergic to lutein or omega3 fatty acids
Key exclusion criteria (1) Presence of cataracts of a severity sufficient to materially affect the above evaluations of visual function
(2)Undergone cataract surgery within the previous 3 months
(3)Pupile size of less than 6.5 mm
(4)Presence of glaucoma, diabetic retinopathy, or other serious disease of the fundus
(5)Myopia of -6D or higher
(6)Presence of hepatopathy, nephropathy, or cardiac disease of a severity sufficient to affect the evaluations of the supplements to be taken by patients
(7)Receiving photosensitive drugs such as phenothiazine, chloroquine, and tetracycline on an ongoing basis
(8)Regular use of lutein or DHA in the past 3 months
(9)Judged by the investigator to be ineligible for other reasons
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akira Obana
Organization Seirei Hamamatsu General Hospital
Division name Department of Ophthalmology
Zip code
Address 2-12-12 Sumiyoshi, Naka-ku, Hamamatsu City, 430-8558, Japan
TEL 053-474-2222
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Seirei Hamamatsu General Hospital (Shizuoka Prefecture)
Division name Department of Ophthalmology
Zip code
Address 2-12-12 Sumiyoshi, Naka-ku, Hamamatsu City, 430-8558, Japan
TEL 053-474-2222
Homepage URL
Email

Sponsor
Institute Seirei Hamamatsu Genaral Hospital (Shizuoka Prefecture)
Institute
Department

Funding Source
Organization Otsuka Pharmaceutical Co.,Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Japan Ocular Carotenoids Study Group(JOCS)
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 北海道大学大学院医学研究科医学専攻研究眼科学講座(北海道)、日本大学医学部眼科(東京都)、聖隷浜松病院眼科(静岡県)、神戸大学医学部眼科(兵庫県)、島根大学医学部眼科(島根県)
Department of Ophthalmology and Visual Sciences, Hokkaido University Graduate School of Medicine, Department of Ophthalmology, Nihon University School of Medicine, Department of Ophthalmology, Seirei Hamamatsu General Hospital, Department of Ophthalmology, Kobe University School of Medicine, Department of Ophthalmology, Shimane University School of Medicine

Other administrative information
Date of disclosure of the study information
2010 Year 12 Month 28 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2010 Year 05 Month 24 Day
Date of IRB
Anticipated trial start date
2011 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 12 Month 28 Day
Last modified on
2012 Year 05 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005712

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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