UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022734
Receipt number R000026189
Scientific Title Analyses of intravitreal antioxidant potential and cytokine profiles of various vitreoretinal diseases
Date of disclosure of the study information 2016/12/01
Last modified on 2021/07/02 11:16:58

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Basic information

Public title

Analyses of intravitreal antioxidant potential and cytokine profiles of various vitreoretinal diseases

Acronym

Biochemical analyses of the vitreous with vitreoretinal diseases

Scientific Title

Analyses of intravitreal antioxidant potential and cytokine profiles of various vitreoretinal diseases

Scientific Title:Acronym

Biochemical analyses of the vitreous with vitreoretinal diseases

Region

Japan


Condition

Condition

vitreoretinal diseases

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To understand mechanisms and pathogenesis of vitreoretinal diseases including macular hole, epiretinal membrane, proliferative diabetic retinopathy, rhegmatogenous retinal detachment and retinal vein occlusion, the vitreous fluid obtained by vitrectomy are biochemically analyzed, with specifically interests in the antioxidant potentials and cytokine profiles.

Basic objectives2

Others

Basic objectives -Others

biochemical analyses

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Differences in the antioxidant potentials and cytokine profiles between various vitreoretinal diseases

Key secondary outcomes

Characteristic patterns of the antioxidant potentials and cytokine profiles in each of various vitreoretinal diseases


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Placebo

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is considered as a block.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

5

Purpose of intervention

Prevention

Type of intervention

Other

Interventions/Control_1

Collection of 0.5ml of undiluted vitreous fluid before starting vitrectomy for rhegmatogenous retinal detachment.

Interventions/Control_2

Collection of 0.5ml of undiluted vitreous fluid before starting vitrectomy for macular hole.

Interventions/Control_3

Collection of 0.5ml of undiluted vitreous fluid before starting vitrectomy for epiretinal membrane.

Interventions/Control_4

Collection of 0.5ml of undiluted vitreous fluid before starting vitrectomy for proliferative diabetic retinopathy.

Interventions/Control_5

Collection of 0.5ml of undiluted vitreous fluid before starting vitrectomy for retinal vein occlusion.

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

90 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients with various vitreoretinal diseases which need to be treated by vitreous surgery.

Key exclusion criteria

Patients who were previously undergone vitrectomy surgery.

Target sample size

200


Research contact person

Name of lead principal investigator

1st name Mitsuru
Middle name
Last name Nakazawa

Organization

Hirosaki University Graduate school of Medicine

Division name

Department of Ophthalmology

Zip code

036-8562

Address

5 Zaifu-cho, Hirosaki, 036-8562, Japan

TEL

0172-39-5094

Email

mitsuru@hirosaki-u.ac.jp


Public contact

Name of contact person

1st name Mitsuru
Middle name
Last name Nakazawa

Organization

Hirosaki University Graduate school of Medicine

Division name

Department of Ophthalmology

Zip code

036-8562

Address

5 Zaifu-cho, Hirosaki, 036-8562, Japan

TEL

0172-39-5094

Homepage URL

http://www.med.hirosaki-u.ac.jp/~ophthal/

Email

mitsuru@hirosaki-u.ac.jp


Sponsor or person

Institute

Department of Ophthalmology, Hirosaki University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

self-funding

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

Committee of ethics in Hirosaki University Graduate School of Medicine

Address

5 Zaifu-cho, Hirosaki

Tel

0172-39-5094

Email

mituru@hirosaki-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

弘前大学医学部附属病院


Other administrative information

Date of disclosure of the study information

2016 Year 12 Month 01 Day


Related information

URL releasing protocol

http://www.med.hirosaki-u.ac.jp/~ophthal/

Publication of results

Partially published


Result

URL related to results and publications

http://www.med.hirosaki-u.ac.jp/~ophthal/

Number of participants that the trial has enrolled

200

Results

The results indicated that the biological antioxidative potential was decreased in the vitreous gel with retinal detachment, and that inflammatory reactions are related to the pathobiochemistry in the vitreous with retinal detachment.

Results date posted

2021 Year 07 Month 02 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

patients who undergo vitreous surgery due to rhegmatogenous retinal detachment, macular hole or diabetic retinopathy.

Participant flow

an aliquot of the vitreous gel is preserved during surgery.

Adverse events

no

Outcome measures

biological antioxidant potential and inflammatory cytokines

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2015 Year 04 Month 17 Day

Date of IRB

2015 Year 04 Month 17 Day

Anticipated trial start date

2015 Year 05 Month 01 Day

Last follow-up date

2020 Year 03 Month 31 Day

Date of closure to data entry

2020 Year 03 Month 31 Day

Date trial data considered complete

2020 Year 06 Month 14 Day

Date analysis concluded

2020 Year 12 Month 31 Day


Other

Other related information

The data have been published in the following articles.

Maeno A, Suzuki Y, Adachi K, Takahashi S, Yokoi Y, Nakazawa M.
Characterization of biological antioxidant potential in the vitreous fluid from patients with rhegmatogenous retinal detachment. Acta Ophthalmol 94 (6), e515-516, 2016, doi: 10.1111/aos.13002.
Suzuki Y, Suzuki K, Kudo T, Metoki T, Nakazawa M.
Level of vascular endothelial growth factor in the vitreous fluid of proliferative diabetic retinopathy patients and postoperative complications of vitrectomy. Ophthalmologica 236, 133-138, 2016.
Takahashi S, Adachi K, Suzuki Y, Maeno A, Nakazawa M.
Profiles of inflammatory cytokines in the vitreous fluid from patients with rhegmatogenous retinal detachment and their correlations with clinical features. BioMed Res Int 2016, article ID 4256183, 9 pages, 2016. doi:10.1155/2016/4256183
Suzuki Y, Adachi K, Takahashi S, Maeno A, Nakazawa M.
Oxidative stress in the vitreous fluid with rhegmatogenous retinal detachment. J Clin Exp Ophthalmol 6: 682-686, 2017. Doi:10.4172/2155-9570.1000682


Management information

Registered date

2016 Year 06 Month 14 Day

Last modified on

2021 Year 07 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026189


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name
2018/12/16 Suzuki oxidative paper.pdf