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

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 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

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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name