UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018106 |
|---|---|
| Receipt number | 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 | 2023/01/04 22:34:29 |
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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
osaka.rie@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
ganka@med.kagawa-u.ac.jp
Sponsor or person
Institute
Department of Ophthalmology, Kagawa university faculty of medicine
Institute
Department
Personal name
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
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
| 2021 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2022 | Year | 07 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 06 | Month | 26 | Day |
Last modified on
| 2023 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020961
