UMIN-CTR Clinical Trial

Basic information
Public title	Assessment of efficacy of Navigated Retina Laser Therapy (NAVILAS) with Indocyanine Green Angiography-guided for diffuse macular edema
Acronym	Efficacy of NAVILAS laser with IA guided for diffuse macular edema
Scientific Title	Assessment of efficacy of Navigated Retina Laser Therapy (NAVILAS) with Indocyanine Green Angiography-guided for diffuse macular edema
Scientific Title:Acronym	Efficacy of NAVILAS laser with IA guided for diffuse macular edema
Region	Japan

Condition
Condition	Diffuse macular edema
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the efficacy of Navigated Retina Laser Therapy (NAVILAS) with Indocyanine Green Angiography-guided for diffuse macular edema
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	best corrected visual acuity (BCVA) Central retinal thickness measured by Cirrus OCT
Key secondary outcomes	macular volume measured by Cirrus OCT Intraocular pressure

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	Device,equipment
Interventions/Control_1	Navigated Retina Laser Therapy (NAVILAS)
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	The patient must have diffuse macular edema involving the center of the macula with a corresponding leakage on fluorescein angiography.
Key exclusion criteria	any intraocular sugary or sub-Tenon's capsule Steroid injection within 3 months prior to study entry. any laser photocoagulation within 6 months prior to study entry. any case who can not detect macular detail by OCT due to cataract can not do fluorescein angiography due to renal dysfunction patients who are currently taking systemic steroid patients who are pregnant, or have possibility of pregnant eyes with membrane traction by OCT the patients whose doctor admit not ideal to entry to this study
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yuichiro Ogura
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 JAPAN
TEL	052-853-8251
Email	ogura@med.nagoya-cu.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Miho Nozaki
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 JAPAN
TEL	052-853-8251
Homepage URL
Email	nozakim@med.nagoya-cu.ac.jp

Sponsor
Institute	Nagoya City University Hospital
Institute
Department

Funding Source
Organization	Ellex
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

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	2013 Year 12 Month 03 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	Completed
Date of protocol fixation	2013 Year 08 Month 13 Day
Date of IRB
Anticipated trial start date	2013 Year 12 Month 05 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	2013 Year 12 Month 03 Day
Last modified on	2015 Year 01 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014599

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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