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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000018106
Receipt No. R000020961
Scientific Title Treatment outcomes in wet age-related macular degeneration using a Treat-and-Extend regimen.
Date of disclosure of the study information 2015/06/26
Last modified on 2020/09/03

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Basic information
Public title Treatment outcomes in wet age-related macular degeneration using a Treat-and-Extend regimen.
Acronym Treatment outcomes in wet AMD using Treat-and-Extend regimen.
Scientific Title Treatment outcomes in wet age-related macular degeneration using a Treat-and-Extend regimen.
Scientific Title:Acronym Treatment outcomes in wet AMD using Treat-and-Extend regimen.
Region
Japan

Condition
Condition Age-related macular degeneration
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the efficacy of intravitreal anti-VEGF agents using Treat & Extend regimen in patients with wet AMD
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change of visual acuity at month 12,24,36.
Key secondary outcomes The average treatment number according to the medicine , central macular thickness, change of leakage in retinal region, leakage from a polyp, leakage from choroidal neovascularization, subretinal fluid , the rate of incident and the enlargement of the geographic atrophy

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 Treatment
Type of intervention
Medicine
Interventions/Control_1 Eylea (aflibercept)
Lucentis(ranibizumab)
Macugen(Pegaptanib sodium)
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
45 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) BCVA: 0.1-1.0
2) AMD with subfoveal fluid on fluorescent angiography, indocyanine green angiography and/or optical coherence tomography
3) Willingness to provide written informed consent
4) outpatient
Key exclusion criteria 1) Greatest Linear Dimension (GLD) of the total lesion area <12 Macular Photocoagulation Study Disc Areas
2) Presence of subretinal hemorrhage, scar or macular fibrosis (>50% lesion area)
3) Prior treatment with anti-VEGF drug, photodynamic therapy
4) Prior treatment with dexamethasone (<6 months) or triamcinolone (<30 days), intraocular surgery (<3 months)
5) Active intraocular inflammation
6) Hypersensitivity or allergy to fluorescein or indocyanine green, clinically significant drug allergy or known hypersensitivity to therapeutic or diagnostic protein products
7) Patient who the doctor in charge judges are ineligible for the study
Target sample size 150

Research contact person
Name of lead principal investigator
1st name Rie
Middle name
Last name Osaka
Organization Kagawa university faculty of medicine
Division name Department of Ophthalmology
Zip code 761-0793
Address 1750-1 Ikenobe Miki-cho, Kagawa 761-0793, Japan
TEL 087-891-2211
Email ganka@med.kagawa-u.ac.jp

Public contact
Name of contact person
1st name Rie
Middle name
Last name Osaka
Organization Kagawa university faculty of medicine
Division name Department of Ophthalmology
Zip code 761-0793
Address 1750-1 Ikenobe Miki-cho, Kagawa 761-0793, Japan
TEL 087-891-2211
Homepage URL
Email ganka@med.kagawa-u.ac.jp

Sponsor
Institute Department of Ophthalmology, Kagawa university faculty of medicine
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ethics committee, Kagawa university faculty of medicine
Address 1750-1 Ikenobe Miki-cho, Kagawa 761-0793, Japan
Tel 087-898-5111
Email chosa@med.kagawa-u.ac.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

Other administrative information
Date of disclosure of the study information
2015 Year 06 Month 26 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
2015 Year 06 Month 22 Day
Date of IRB
2015 Year 06 Month 22 Day
Anticipated trial start date
2015 Year 06 Month 26 Day
Last follow-up date
2020 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2021 Year 07 Month 31 Day

Other
Other related information

Management information
Registered date
2015 Year 06 Month 26 Day
Last modified on
2020 Year 09 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020961

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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