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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000041817
Receipt No. 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 2020/09/17

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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
Email 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
Email tsawada@belle.shiga-med.ac.jp

Sponsor
Institute Department of Ophthalmology, Shiga University of Medical Science
Institute
Department

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
Email 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 Open public recruiting
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
2020 Year 09 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047744

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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