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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000043667
Receipt No. R000049864
Scientific Title Cytokine concentration in aqueous humor of patients with neovascular age-related macular degeneration before and after anti-VEGF therapy
Date of disclosure of the study information 2021/03/18
Last modified on 2021/03/18

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Basic information
Public title Cytokine concentration in eye of patients with age-related macular degeneration before and after anti-VEGF therapy
Acronym Cytokine concentration in eyes with age-related macular degeneration
Scientific Title Cytokine concentration in aqueous humor of patients with neovascular age-related macular degeneration before and after anti-VEGF therapy
Scientific Title:Acronym Cytokine concentration in eyes with 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 investigate the change of cytokines in eye with neovascular age-related macular degeneration before and after anti-vascular endothelial growth factor therapy and the correlation between the change in cytokines and endophthalmitis, retinal vasculitis, or retinal vessels occlusion.
Basic objectives2 Others
Basic objectives -Others To investigate the effect of intravitreal injection of anti-vascular endothelial growth factor therapy on cytokines in eye
in
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The cytokines concentration in aqueous humor before and after the intravitreal injection of anti-vascular endothelial growth factor
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
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, 50 years old or older with informed consent.
Key exclusion criteria Patients are judged to be inappropriate by doctors in charge. Especially the patients with narrow angle who are concerned to occur capsule rupture of lens are excluded.
Patients who would like to withdraw their consent.
Target sample size 40

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 0775483576
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
2021 Year 03 Month 18 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
2021 Year 02 Month 25 Day
Date of IRB
2021 Year 02 Month 25 Day
Anticipated trial start date
2021 Year 03 Month 18 Day
Last follow-up date
2023 Year 10 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 October 31, 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, anterior chamber cells and flare by flare cell meter
Images: funds angiography, optical coherence tomography (OCT), OCT-angiography, central retinal thickness by OCT,
Aqueous cytokines concentration, aqueous VEGF concentration

Management information
Registered date
2021 Year 03 Month 18 Day
Last modified on
2021 Year 03 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049864

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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