UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017081
Receipt number R000019815
Scientific Title Comparison of intravitreal ranibizumab injection with or without tissue plasminogen activator in the treatment of type 2 choroidal neovascularization
Date of disclosure of the study information 2015/04/10
Last modified on 2015/04/08 20:59:02

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Basic information

Public title

Comparison of intravitreal ranibizumab injection with or without tissue plasminogen activator in the treatment of type 2 choroidal neovascularization

Acronym

Effect of tissue plasminogen activator on type 2 choroidal neovascularization

Scientific Title

Comparison of intravitreal ranibizumab injection with or without tissue plasminogen activator in the treatment of type 2 choroidal neovascularization

Scientific Title:Acronym

Effect of tissue plasminogen activator on type 2 choroidal neovascularization

Region

Japan


Condition

Condition

neovascular age-related macular degeneration

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Anti-vascular endothelial growth factor (VEGF) therapies can effectively suppress development and progression of choroidal neovascularization (CNV). However, they possess little ability to regress once-developed fibrovascular tissue. The purpose of this study is to evaluate the impacts of fibrinolysis with Tissue plasminogen activator (tPA) on type 2 CNV.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Best-corrected visual acuities (BCVAs)

Key secondary outcomes

Central retinal thickness
Macular volume
The ILM-RPE thickness at the thickest point of the subretinal fibrinous and/or fibrovascular tissues


Base

Study type


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

intravitreal injection of tPA combined with intravitreal ranibizumab

Interventions/Control_2

intravitreal ranibizumab

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

Age related macular degeneration with type 2 choroidal neovascularization,

Key exclusion criteria

previous treatments involving laser photocoagulation or photodynamic therapy

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tsutomu Yasukawa

Organization

Nagoya City University Graduate School of Medical Sciences

Division name

Department of Ophthalmology and Visual Science

Zip code


Address

1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, JAPAN

TEL

052-853-8251

Email

yasukawa@med.nagoya-cu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tsutomu Yasukawa

Organization

Nagoya City University Graduate School of Medical Sciences

Division name

Department of Ophthalmology and Visual Science

Zip code


Address

1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, JAPAN

TEL

052-853-8251

Homepage URL


Email

yasukawa@med.nagoya-cu.ac.jp


Sponsor or person

Institute

Department of Ophthalmology and Visual Science
Nagoya City University Graduate School of Medical Sciences

Institute

Department

Personal name



Funding Source

Organization

none

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


Address


Tel


Email



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

2015 Year 04 Month 10 Day


Related information

URL releasing protocol


Publication of results

Partially published


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

2010 Year 03 Month 01 Day

Date of IRB


Anticipated trial start date

2010 Year 04 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 04 Month 08 Day

Last modified on

2015 Year 04 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019815


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name