UMIN-CTR Clinical Trial

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
Email	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
Email	h.shimizu@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053991