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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000012401
Receipt No. R000014506
Scientific Title Assessment of safety and initial therapeutic efficacy of non-damaging patterned scanning laser phototherapy in patients with diffuse diabetic macular edema
Date of disclosure of the study information 2013/12/02
Last modified on 2016/07/08

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Basic information
Public title Assessment of safety and initial therapeutic efficacy of non-damaging patterned scanning laser phototherapy in patients with diffuse diabetic macular edema
Acronym safety and efficacy of patterned scanning laser phototherapy in patients with diffuse diabetic macular edema
Scientific Title Assessment of safety and initial therapeutic efficacy of non-damaging patterned scanning laser phototherapy in patients with diffuse diabetic macular edema
Scientific Title:Acronym 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.

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

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
1st name
Middle name
Last name Yuichiro Ogura
Organization Nagoya City University Gradate School of Medical Sciences
Division name Department of Ophthalmology and Visual Science
Zip code
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
1st name
Middle name
Last name Miho Nozaki
Organization Nagoya City University Gradate School of Medical Sciences
Division name Department of Ophthalmology and Visual Science
Zip code
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

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)

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 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

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 Terminated
Date of protocol fixation
2013 Year 06 Month 12 Day
Date of IRB
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

Other
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

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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