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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000036698
Receipt No. R000041813
Scientific Title Pathophysiology and visual prognosis of cases with submacular hemorrhage: multicenter retrospective observational study
Date of disclosure of the study information 2019/05/10
Last modified on 2019/05/09

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Basic information
Public title Pathophysiology and visual prognosis of cases with submacular hemorrhage: multicenter retrospective observational study
Acronym Retrospective observational study of cases with submacular hemorrhage
Scientific Title Pathophysiology and visual prognosis of cases with submacular hemorrhage: multicenter retrospective observational study
Scientific Title:Acronym Retrospective observational study of cases with submacular hemorrhage
Region
Japan

Condition
Condition Submacular hemorrhage associated with wet age related macular degeneration, retinal macroaneurysm or any other disease.
Classification by specialty
Infectious disease Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In wet age-related macular degeneration involving the fovea, intravitreous administration of vascular endothelial growth factor (VEGF) inhibitors and the usefulness of photodynamic therapy (PDT) has been demonstrated. However, during the course of treatment there may be extensive submacular hemorrhage or hemorrhagic retinal pigment epithelial detachment even during treatment, and there is no established treatment for submacular hemorrhage and the treatment content is case or it depends on the facility. We will conduct observational research on various clinical findings and treatment options at the time of hemorrhage and prognosis in cases with severe submacular hemorrhage. At the same time, it is also examined whether the disease duration, treatment, presence of retinal pigment epithelial detachment may affect the prognosis after hemorrhage. This is expected to provideuseful information leading to the selection of an appropriate medical care policy and treatment.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Best corrected visual acuity (BCVA) and change of BCVA
Key secondary outcomes Findings as fundus and optical coherence tomography at and after hemorrhage
Pathology and treatment history before bleeding in age related macular degeneration
Kind of treatment and its effect
Association with systemic complications and oral administration


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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Subretinal hemorrhage between April 2015 and September 2018
2) Subretinal hemorrhage including the fovea more than 2 disc area
3) Ophthalmic imaging findings such as fundus photography, optical coherence tomography (optical coherence tomography angiography, fundus autofluorescence) can be obtained
4) More than 3 months have been observed after onset of subretinal hemorrhage
Key exclusion criteria Cases in which the affected eye has a complication of retinal detachment, diabetes retinopathy, retinal vein occlusion, uveitis and other retinal vitreous diseases.
Cases that do not agree to provide data.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Tsutomu
Middle name
Last name Yasukawa
Organization Nagoya City University Graduate School of Medical Sciences.
Division name Department of Ophthalmology and Visual Science
Zip code 467-8601
Address 1 Kawasumi, Mizuho, Nagoya, Japan
TEL 052-853-8251
Email yasukawa@med.nagoya-cu.ac.jp

Public contact
Name of contact person
1st name Aki
Middle name
Last name Kato
Organization Nagoya City University Graduate School of Medical Sciences.
Division name Department of Ophthalmology and Visual Science
Zip code 467-8601
Address 1 Kawasumi, Mizuho, Nagoya, Japan
TEL 052-853-8251
Homepage URL
Email akikato@med.nagoya-cu.ac.jp

Sponsor
Institute Department of Ophthalmology and Visual Science, Nagoya City University Graduate School of Medical Sciences.
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s) none

IRB Contact (For public release)
Organization Clinical research management center, Nagoya City University Hospital
Address 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi
Tel 052-858-7215
Email ctmc@med.nagoya-cu.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
2019 Year 05 Month 10 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 200
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 No longer recruiting
Date of protocol fixation
2018 Year 12 Month 14 Day
Date of IRB
2019 Year 01 Month 09 Day
Anticipated trial start date
2019 Year 02 Month 01 Day
Last follow-up date
2019 Year 09 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Recruitment of participants has already finished for retrospective observational examination.

Management information
Registered date
2019 Year 05 Month 09 Day
Last modified on
2019 Year 05 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041813

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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