UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020324 |
|---|---|
| Receipt number | R000023472 |
| Scientific Title | Relationship between contrast sensitivity, vision-related quality of life and foveal microstructure in patients with diabetic macular edema following aflibercept therapy. |
| Date of disclosure of the study information | 2016/03/08 |
| Last modified on | 2018/12/26 14:57:51 |
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Basic information
Public title
Relationship between contrast sensitivity, vision-related quality of life and foveal microstructure in patients with diabetic macular edema following aflibercept therapy.
Acronym
Relationship between contrast sensitivity, vision-related quality of life and foveal microstructure in patients with diabetic macular edema following aflibercept therapy.
Scientific Title
Relationship between contrast sensitivity, vision-related quality of life and foveal microstructure in patients with diabetic macular edema following aflibercept therapy.
Scientific Title:Acronym
Relationship between contrast sensitivity, vision-related quality of life and foveal microstructure in patients with diabetic macular edema following aflibercept therapy.
Region
| Japan |
Condition
Condition
Diabetic macular edema
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of aflibercept on contrast sensitivity and vision-related quality of life in patients with diabetic macular edema.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase IV
Assessment
Primary outcomes
Contrast sensitivity from baseline to 12 month
Key secondary outcomes
Visual acuity from baseline to 12 month
Central macular thickness(CMT) from baseline to 12 month
Contrast sensitivity at every visit
Vision-related quality of life (VR-QOL) from baseline to 12 month
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
visual acuity with the Landolt chart at every visit
Central macular thickness (CMT) by Spectral Domain-OCT at every visit
Contrast sensitivity by CSV-1000LV chart at every visit
Vision-related quality of life (VR-QOL) with the National Eye Institute 25-item visual function questionnaire (NEI VFQ-25) at pretreatment, 3, 6, and 12 month
Adverse eventsr/ serious adverse events
Interventions/Control_2
Interventions/Control_3
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
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Adults more than 20 years with type 1 or 2 diabetes mellitus
2.Subjects with DME secondary to diabetes mellitus involving the center of the macula defined as the area of the center subfield of OCT in the study eye
3.Decrease in vision determined to be primarily the result of DME in the study eye
4.BCVAmore than 24 letters
5.Central retinal thickness as assessed by OCT of more than 300 in the study eye
6.Willing and able to comply with clinic visits and study related procedures
7.Provide a signed informed consent form after receiving a explanation about this study
Key exclusion criteria
(1)The study eye is better than fellow eye
(2)History of vitreoretinal surgery
(3)Laser photocoagulation in the study eye within 90 days before Day 1
(4)More than 1 treatment with Direct laser/grid laser
(5)Previous use of intraocular or periocular corticosteroids in the study eye within 120 days
(6)Previous treatment with anti-angiogenic drugs in either eye within 90 days
(7)Proliferative diabetic retinopathyin the study eye,
(8)History of idiopathic or autoimmune uveitis
(9)Any intraocular surgerywithin 90 days before Day 1
(10)Aphakia
(11)Vitreomacular traction
(12)Current iris neovascularization, vitreoushemorrhage, or tractional retinal detachment
(13)Pre-retinal fibrosis
(14)Structural damage to the center of the macula
(15)History of endophthalmitis
(16)Infectious blepharitis, keratitis,scleritis or conjunctivitis
(17)Uncontrolled graucoma
(18)High intraocular pressure in the study ey
(19)High myopia
(20)History of disease that can result in decreased visual acuity
(21)Only one functional eye
(22)Ocular media insufficient to obtain fundus and OCT images in the study eye
(23)Serious systemic infection
(24)Administration of systemic anti-angiogenic agents within 180 days before day 1
(25)Uncontrolled blood pressure
(26)Uncontrolled diabetes mellitus
(27)History of cerebrovascular accident and/or Myocardial infarction within 180 days before day 1
(28)Renal failure
(29)Systemic disease patients who need treatment that may affect outcomes
(30)Pregnant or breast-feeding women
(31)Female subjects wish for a pregnancy within the intended treatment period
(32)Allergy to fluorescein
(33)Hypersensitive to aflibercept
(34)Previous participation in any studies of investigational drugs within 30 days preceding Day 1
(35)Subjects who judged by a investigator to be inappropriate for the study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Fumiki Okamoto |
Organization
University of Tsukuba
Division name
Department of Ophthalmology, Faculty of Medicine
Zip code
Address
1-1-1 Tennoudai, Tsukuba, Ibaraki, 305-8575 Japan
TEL
029-853-3148
fumiki-o@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Fumiki Okamoto |
Organization
University of Tsukuba
Division name
Department of Ophthalmology, Faculty of Medicine
Zip code
Address
1-1-1 Tennoudai, Tsukuba, Ibaraki, 305-8575 Japan
TEL
029-853-3148
Homepage URL
fumiki-o@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Bayer
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
筑波大学附属病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 03 | Month | 08 | 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
| 2017 | Year | 02 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 05 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 05 | Day |
Date analysis concluded
| 2018 | Year | 05 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 12 | Month | 24 | Day |
Last modified on
| 2018 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023472
