UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004804 |
|---|---|
| Receipt number | 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 | 2021/04/13 12:44:52 |
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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 | Akira |
| Middle name | |
| Last name | Obana |
Organization
Seirei Hamamatsu General Hospital
Division name
Department of Ophthalmology
Zip code
430-8558
Address
Naka-ku
TEL
0534742222
obana@sis.seirei.or.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Asano |
Organization
Seirei Hamamatsu General Hospital (Shizuoka Prefecture)
Division name
Department of Ophthalmology
Zip code
430-8558
Address
Naka-ku
TEL
053-474-2222
Homepage URL
ryoasa0120@googlemail.com
Sponsor or person
Institute
Seirei Hamamatsu Genaral Hospital (Shizuoka Prefecture)
Institute
Department
Personal name
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
Seirei Hamamatsu General Hospital
Address
2-12-12 Sumiyoshi, Naka-ku, Hamamatsu City
Tel
0534742222
obana@sis.seirei.or.jp
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
WOC2014
Publication of results
Published
Result
URL related to results and publications
WOC2014
Number of participants that the trial has enrolled
28
Results
The mean macular pigment optical density levels increased at month 12 compared to the baseline in all groups, but a statistically significant increase was observed only in group MMLD (multivitamins and minerals plus 12 mg lutein, p=0.023, Wilcoxon signed rank test). The mean frequency of retreatment was 2.6 in group MM ( multivitamins and minerals), 3.3 in group MML, and 1.6 in MMLD (multivitamins and minerals, plus lutein and 144 mg docosahexaenoic acid, p=0.338, Kruskal-Wallis test).
Results date posted
| 2021 | Year | 04 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A total of 28 Japanese patients with neovascular AMD were selected that showed improvement of exudative changes after three consecutive injections of intravitreal ranibizumab.
Participant flow
Nine patients were administered multivitamins and minerals (group MM), eight were administered multivitamins and minerals plus 12 mg lutein per day (group MML), and eleven were administered multivitamins and minerals, plus lutein and 144 mg docosahexaenoic acid (DHA) per day plus 23 mg eicosapentaenoic acid (EPA) per day (group MMLD).
Adverse events
None
Outcome measures
Macular pigment optical density, Number of Ranibizumab treatment for one year
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2010 | Year | 05 | Month | 24 | Day |
Date of IRB
| 2010 | Year | 02 | Month | 17 | Day |
Anticipated trial start date
| 2011 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 09 | Month | 30 | Day |
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
| 2021 | Year | 04 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005712
