UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029497 |
|---|---|
| Receipt number | R000033699 |
| Scientific Title | Transition of visual acuity before initial treatment with neovascular age-related macular degeneration over the past years (A multicenter retrospective study) |
| Date of disclosure of the study information | 2017/10/10 |
| Last modified on | 2024/03/05 15:39:45 |
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Basic information
Public title
Transition of visual acuity before initial treatment with neovascular age-related macular degeneration over the past years (A multicenter retrospective study)
Acronym
Transition of visual acuity before initial treatment with neovascular age-related macular degeneration over the past years (A multicenter retrospective study)
Scientific Title
Transition of visual acuity before initial treatment with neovascular age-related macular degeneration over the past years (A multicenter retrospective study)
Scientific Title:Acronym
Transition of visual acuity before initial treatment with neovascular age-related macular degeneration over the past years (A multicenter retrospective study)
Region
| Japan |
Condition
Condition
neovascular age-related macular degeneration
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the difference of the therapeutic effect in the visual acuity before the initial treatment of the photodynamic therapy (PDT), or the anti-vascular endothelial growth factor (VEGF) therapy or PDT with anti-VEGF therapy by using many cases for neovascular age-related macular degeneration over the past years.
Basic objectives2
Others
Basic objectives -Others
Transition of visual acuity before initial treatment and treatment methods
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Visual acuity before initial treatment
Key secondary outcomes
Type of initial treatment
Visual acuity one year and 2 years after the initial treatment
Central subfield retinal thickness before initial treatment, one year and 2 years after the initial treatment
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients of age-related macular degeneration with choroidal neovascularization who received photodynamic therapy, intravitreal injections of ranibizumab, aflibercept, pegaptanib, bevacizumab or topical administration of the steroid in the past 10 years (January 1, 2006 to December 31, 2015) and were able to follow more than one year.
Key exclusion criteria
Patients have received photodynamic therapy or intravitreal injections of ranibizumab, aflibercept, pegaptanib, or bevacizumab before receiving the initial treatment at each hospital, or patients who refused to participate this study, or patients who are judged to be unfit as the participants of this study.
Target sample size
5000
Research contact person
Name of lead principal investigator
| 1st name | Masahito |
| Middle name | |
| Last name | Ohji |
Organization
Shiga University of Medical Science
Division name
Department of Ophthalmology
Zip code
520-2192
Address
Seta Tsukinowa-cho, Otsu, Shiga, JAPAN
TEL
077-548-2276
ohji@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | Tomoko |
| Middle name | |
| Last name | Sawada |
Organization
Shiga University of Medical Science
Division name
Department of Ophthalmology
Zip code
520-2192
Address
Seta Tsukinowa-cho, Otsu, Shiga, JAPAN
TEL
077-548-2276
Homepage URL
tsawada@belle.shiga-med.ac.jp
Sponsor or person
Institute
Department of Ophthalmology, Shiga University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology (Japan)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committe of Shiga Univercity of Medical Science
Address
Seta Tsukinowacho, Otsu, Shiga, JAPAN
Tel
0775483576
hqrec@belle.shiga-med.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
滋賀医科大学眼科学講座 Department of Ophthalmology, Shiga University of Medical Science
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 10 | Month | 10 | Day |
Related information
URL releasing protocol
http://www.shiga-med.ac.jp/hospital/doc/ethics/files/1633.pdf
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s00417-020-05005-y
Number of participants that the trial has enrolled
3096
Results
We investigated the change of baseline visual acuity and treatments for age-related macular degeneration from 2009 to 2015. Baseline visual acuity became significantly better over the 10-year study period. Visual acuity at 2 years significantly improved from baseline in patients who recieved initial treatment from 2012 to 2015.
Results date posted
| 2024 | Year | 03 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Japanese patients with naive age-related macular degeneration
Participant flow
Our study is a retrospective, multicenter, case series. We retrospectivelly reviewed the data from medical records.
Adverse events
none
Outcome measures
Age at initial treatment for naive age-related macular degeneration, gender, date of initial treatment for naive age-related macular degeneration, type of age-related macular degeneration, and type of initial treatment, visual acuity and central retinal subfield thickness at baseline and after 1 and 2 years of follow-up.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 08 | Month | 30 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 30 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 10 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 12 | Month | 31 | Day |
Other
Other related information
The participants began their initial treatment for neovascular age-related macular degeneration at each research facility in the past decade (January 1, 2006 to December 31, 2015) and were able to follow the passage of more than one year.
Management information
Registered date
| 2017 | Year | 10 | Month | 10 | Day |
Last modified on
| 2024 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033699
