UMIN-CTR Clinical Trial

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

Diffuse diabetic macular edema

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Nagoya City University Gradate School of Medical Sciences

Institute

Department

Personal name

Organization

Topcon

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan

Co-sponsor

St. Luke's international hospital

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

名古屋市立大学病院（愛知県）、聖路加国際病院（東京都）

Date of disclosure of the study information

2013

Year

12

Month

02

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2013

Year

11

Month

25

Day

Last modified on

2016

Year

07

Month

08

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014506