UMIN-CTR Clinical Trial

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
Email	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
Email	ryoasa0120@googlemail.com

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	Seirei Hamamatsu General Hospital
Address	2-12-12 Sumiyoshi, Naka-ku, Hamamatsu City
Tel	0534742222
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005712