UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Assessment of safety and initial therapeutic efficacy of non-damaging patterned scanning laser phototherapy in patients with diffuse diabetic macular edema
Title of the study (Brief title)	safety and efficacy of patterned scanning laser phototherapy in patients with diffuse diabetic macular edema
Region	Japan

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

Objectives
Narrative objectives1	To establish the titration protocol for non-damaging ms-pulsed laser treatment of the macula with 532 or 577nm wavelength. To evaluate the short term (6 months) safety and efficacy of the non-damaging laser treatment for diabetic macular edema (DME).
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Best Corrected visual logMAR acuity (BCVA) Central macular thickness by OCT Retinal sensitivity measured by microperimetry
Key secondary outcomes	Evaluation of leakage areas on FA.

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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	patterned laser phototherapy
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	The patient must have macular edema involving the center of the macula with a corresponding leakage on fluorescein angiography. Thickening of the fovea of at least 300 microns (thickness of the central point in OCT) with a standard deviation of the center point <10% and signal strength of 5 OCT ILM and borders (internal limiting membrane) and RPE (retinal pigment epithelium) properly identified. Also, the initial OCT must be confirmed by repeated measurements on the same day, with the thickness of the central point being within 10% between measurements. In cases where the OCT imaging program can not properly define the limits of ILM and RPE, if the investigator can obtain an estimate of the thickness of the manual by OCT central point of at least 300 microns, the patient will be considered eligible. The distance visual acuity in the better eye corrected the study must have an index between 0.3 and 1.0 LogMAR visual acuity inclusive (Snellen equivalent of 20/40 to 20/200). Clear media and eye pupil dilation adequate to allow fundus photography with good quality. Intraocular pressure not exceeding 21 mmHg. The ophthalmologist should feel comfortable with the delay of the focal laser treatment (direct and grid, as needed) by at least 12 weeks in the study eye. Patients with diabetes Type 1 or Type 2 as defined by WHO criteria of any gender and age 20 years. Ability to provide a written consent. Ability to return for all study visits.
Key exclusion criteria	Eyes with scatter photocoagulation (PRP) one month prior the enrollment, or eyes where scatter photocoagulation is required now, or it likely to be needed over the next 6months. Presence of any abnormality that is likely to confound the assessment of the improvement in visual acuity in eyes with macular edema to resolve or improve as an area of hard exudates involving the foveal avascular zone, epiretinal membrane associated with signs of contraction and / or significant opacification, or the presence of chorioretinal atrophy involving the center of the macula. Vitreomacular traction determined clinically and / or OCT, which in the opinion of the investigator, contributes to macular edema and prevents the improvement with treatment. Any cause of macular edema other than DME. Atrophy / scar / fibrosis involving the center of the macula, including evidence of atrophy treated with laser within 200 microns of the FAZ. Patients who received panphotocoagulation, YAG laser, or peripheral retinal cryoablation (for retinal tears) or focal or grid photocoagulation within the last 12 weeks or more of treatment with focal or grid laser. Significant opacities of the optical medium, including cataracts, which may interfere with visual acuity, assessment of toxicity or photography background. Patients will not be included if they have high probability of requiring cataract surgery within the next year. Any intraocular surgery within 6 months prior to study entry. Prior peeling of ERM or ILM. Any major surgical procedure within one month of study entry Prior irradiation of the head region of the eye under study. Any previous pharmacological treatment for DME or at any time during the last 90 days for any other condition. Important known allergies to sodium fluorescein dye used in angiography. Acute ocular or periocular infection.
Target sample size	10

Research contact person
Name of lead principal investigator	Yuichiro Ogura
Organization	Nagoya City University Gradate School of Medical Sciences
Division name	Department of Ophthalmology and Visual Science
Address	1 Kawasumi Mizuho-cho Mizuho-ku Nagoya
TEL	052-853-8251
Email	ogura@med.nagoya-cu.ac.jp

Public contact
Name of contact person	Miho Nozaki
Organization	Nagoya City University Gradate School of Medical Sciences
Division name	Department of Ophthalmology and Visual Science
Address	1 Kawasumi Mizuho-cho Mizuho-ku Nagoya
TEL	052-853-8251
Homepage URL
Email	nozakim@med.nagoya-cu.ac.jp

Sponsor
Institute	Nagoya City University Gradate School of Medical Sciences
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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

Other related organizations
Co-sponsor	St. Luke's international hospital
Name of secondary funｄer(s)

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	名古屋市立大学病院（愛知県）、聖路加国際病院（東京都）

Other administrative information
Date of disclosure of the study information	2013 Year 12 Month 02 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 06 Month 12 Day
Anticipated trial start date	2013 Year 12 Month 04 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 11 Month 25 Day
Last modified on	2016 Year 07 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014506