UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047339 |
|---|---|
| Receipt number | R000053991 |
| Scientific Title | Analysis of the effects of anti-vascular endothelial growth factor drugs on the anterior chamber |
| Date of disclosure of the study information | 2022/03/31 |
| Last modified on | 2022/03/31 13:30:05 |
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Basic information
Public title
Analysis of the effects of anti-vascular endothelial growth factor drugs on the anterior chamber
Acronym
Analysis of the effects of anti-VEGF drugs on the anterior chamber
Scientific Title
Analysis of the effects of anti-vascular endothelial growth factor drugs on the anterior chamber
Scientific Title:Acronym
Analysis of the effects of anti-VEGF drugs on the anterior chamber
Region
| Japan |
Condition
Condition
age-related macular degeneration, diabetic macular edema, neovascular glaucoma, myopia choroidal neovascularization
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the present study was to evaluate the effects of anti-VEGF drugs on the anterior chamber by collecting and analyzing the anterior chamber fluid, which is normally discarded at the time of injection or eye surgery in patients who require the use of anti-VEGF drugs, and measuring cytokines in the anterior chamber fluid.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cytokines and proteins in the atrial chamber.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients 20 years of age or older who receive or have received anti-VEGF injections
Key exclusion criteria
Cases with concomitant inflammatory diseases such as uveitis
Cases in which treatment of unknown details has been performed by other hospitals.
Cases in which anterior chamber fluid cannot be safely collected
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Kaneko |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Japan
TEL
052-744-2277
h-kaneko@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Hideyuki |
| Middle name | |
| Last name | Shimizu |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Japan
TEL
052-744-2277
Homepage URL
h.shimizu@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
Nagoya University
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
Address
65 Tsurumai-cho, Showa-ku, Nagoya
Tel
052-744-2479
ethics@med.nagoya-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
| 2022 | Year | 03 | Month | 31 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 03 | Month | 03 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 03 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 03 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
nothing special
Management information
Registered date
| 2022 | Year | 03 | Month | 31 | Day |
Last modified on
| 2022 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053991
