UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046415 |
|---|---|
| Receipt number | R000052959 |
| Scientific Title | Long-term Prognosis of patients with neovascular age-related macular degeneration |
| Date of disclosure of the study information | 2021/12/20 |
| Last modified on | 2024/12/24 11:17:16 |
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Basic information
Public title
Long-term Prognosis of patients with neovascular age-related macular degeneration
Acronym
Long-term Prognosis of patients with neovascular age-related macular degeneration
Scientific Title
Long-term Prognosis of patients with neovascular age-related macular degeneration
Scientific Title:Acronym
Long-term Prognosis of patients with neovascular age-related macular degeneration
Region
| Japan |
Condition
Condition
neovascular age-related macular degeneration
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate long-term prognosis of eyes with neovascular age-related macular degeneration (NV-AMD) treated with photodynamic therapy or anti-vascular endothelial growth factor therapy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Best-corrected visual acuity
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients who were diagnosed with Neovascular age-related macular degeneration at Nagoya City University Hospital since April 2005 underwent intravitreal anti-vascular endothelial growth factor injection or photodynamic therapy, and could be followed up for at least 1 year were included.
Key exclusion criteria
The patients without the necessary data or eyes with history of other vitreoretinal diseases such as retinal detachment, diabetic retinopathy, retinal vein occlusion, and uveitis were excluded.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Tsutomu |
| Middle name | |
| Last name | Yasukawa |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Ophthalmology and Visual Science
Zip code
467-8601
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya
TEL
+81-52-8538251
yasukawa@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | Aki |
| Middle name | |
| Last name | Kato |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Ophthalmology and Visual Science
Zip code
467-8601
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya
TEL
+81-52-8538251
Homepage URL
akikato@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University Graduate School of Medical Sciences
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
institutional review board of Nagoya City University Graduate School of Medical Science
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya
Tel
052-858-7215
clinical_research@med.nagoya-cu.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
| 2021 | Year | 12 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
500
Results
The usefulness of photodynamic therapy was evaluated and published.
The paper is currently being prepared for submission.
The possibility of suspending anti-VEGF therapy was evaluated. We found that it is possible to suspend the therapy in the presence of subretinal fluid and retinal pigment epithelial detachment, but it may be difficult to suspend the therapy in the presence of intraretinal fluid and subretinal hyper reflective material.
The characteristics of AMD with binocular onset were examined.
Results date posted
| 2023 | Year | 06 | Month | 22 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Several papers are currently being submitted and details will be published after acceptance of the papers.
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 27 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We examine cases that were able to be followed up in Nagoya City University for a long period of time after the initial treatment, and examine the characteristics of each disease and its response to treatment, as well as its relation to lifestyle and the development of fellow eyes.
Management information
Registered date
| 2021 | Year | 12 | Month | 19 | Day |
Last modified on
| 2024 | Year | 12 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052959
