UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031065
Receipt number R000035476
Scientific Title Impacts of pneumatic displacement of submacular hemorrhage secondary to age-related macular degeneration on retinal pigment epithelial detachment
Date of disclosure of the study information 2018/01/30
Last modified on 2019/01/31 11:09:11

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Basic information

Public title

Impacts of pneumatic displacement of submacular hemorrhage secondary to age-related macular degeneration on retinal pigment epithelial detachment

Acronym

Pneumatic displacement for submacular hemorrhage and retinal pigment epithelial detachment

Scientific Title

Impacts of pneumatic displacement of submacular hemorrhage secondary to age-related macular degeneration on retinal pigment epithelial detachment

Scientific Title:Acronym

Pneumatic displacement for submacular hemorrhage and retinal pigment epithelial detachment

Region

Japan


Condition

Condition

Exudative age-related macular degeneration

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the impacts of pneumatic displacement with tPA on pigment epithelial detachment and visual outcomes in eyes with submacular hemorrhage secondary to exudative age-related macular degeneration.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Prevalence and flattening rate of pigment epithelial detachment

Key secondary outcomes

Postoperative best-corrected visual acuities and the number of additional treatments


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine Maneuver

Interventions/Control_1

Intravitreal injection of SF6 gas and tPA

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

Eyes with submacular hemorrhage secondary to exudative age-related macular degeneration

Key exclusion criteria

(1) eyes who underwent cataract surgery, (2) intravitreal injection of anti-vascular endothelial growth factor agents, or (3) photodynamic therapy simultaneously with or within a week after pneumatic displacement, (4) who previously underwent vitrectomy, and (5) who required vitrectomy due to vitreous hemorrhage accompanying SRH before or after intravitreal tPA and SF6

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Nagoya City University Graduate School

Organization

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 Nagoya City University Graduate School

Organization

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

Nagoya City University Graduate School of Medical Sciences

Institute

Department

Personal name



Funding Source

Organization

Nagoya City University Graduate School of Medical Sciences

Organization

Division

Category of Funding Organization

Other

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

2018 Year 01 Month 30 Day


Related information

URL releasing protocol


Publication of results

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

2009 Year 03 Month 31 Day

Date of IRB


Anticipated trial start date

2009 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

2018 Year 01 Month 30 Day

Last modified on

2019 Year 01 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035476


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name