UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041817 |
|---|---|
| Receipt number | R000047744 |
| Scientific Title | Concentration of vascular endothelial growth factor and medicine in serum and aqueous humor of patients with neovascular age-related macular degeneration before and after anti-VEGF therapy |
| Date of disclosure of the study information | 2020/09/17 |
| Last modified on | 2024/03/05 15:08:09 |
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Basic information
Public title
VEGF and medicine concentration in serum and eye of patients with age-related macular degeneration before and after anti-VEGF therapy
Acronym
Serum and ocular VEGF and medicine concentration with age-related macular degeneration
Scientific Title
Concentration of vascular endothelial growth factor and medicine in serum and aqueous humor of patients with neovascular age-related macular degeneration before and after anti-VEGF therapy
Scientific Title:Acronym
Serum and ocular VEGF and medicine concentration with age-related macular degeneration
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 general and ocular effect of anti-vascular endothelial growth factor therapy by measuring of serum concentration of vascular endothelial growth factor of patients with age-related macular degeneration before and after the intravitreal injection of anti-vascular endothelial growth factor
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The serum concentration of vascular endothelial growth factor before, 1 week and 1, 2, 3, 4, 5-month after the intravitreal injection of anti-vascular endothelial growth factor
Key secondary outcomes
The correlation of change in best corrected visual acuity or central retinal subfield thickness and serum concentration of vascular endothelial growth factor before, 1 week and 1, 2, 3, 4, 5- month after the injection of anti-vascular endothelial growth factor
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
Patient with neovascular age-related macular degeneration, male or female, people 50 years old or older with informed consent.
Key exclusion criteria
Patients are judged to be inappropriate by doctors in charge.
Patients who would like to withdraw their consent.
Target sample size
30
Research contact person
Name of lead principal investigator
| 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
0775482276
tsawada@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
0775482276
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
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of Shiga University of Medical Science
Address
Seta Tsukinowa-cho, Otsu, Shiga, JAPAN
Tel
077-548-3576
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
滋賀医科大学医学部附属病院（滋賀県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 09 | Month | 17 | 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
Completed
Date of protocol fixation
| 2020 | Year | 07 | Month | 09 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 09 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 17 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patients who visit our hospital and indicate to receive anti-VEGF therapy and start their initial intravitreal injection of anti-VEGF in March 3rd, 2022.
Outcomes;
Background factors: year of birth, gender, life history (smoking history)
Treatment: Type of anti-VEGF drug, number of injection
Ophthalmological observations: visual acuity, intraocular pressure, slit lamp microscopy, ophthalmoscope
Images: funds angiography, central retinal thickness by optical coherence tomography (OCT), OCT-angiography
Aqueous VEGF concentration, serum VEGF concentration
Management information
Registered date
| 2020 | Year | 09 | Month | 17 | 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=R000047744
