UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005648
Receipt number R000005566
Scientific Title Phase II study of Efficacy and Safety of SJE-2079 in the Treatment for Diabetic Macular Edema
Date of disclosure of the study information 2011/05/31
Last modified on 2012/07/04 11:50:57

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Basic information

Public title

Phase II study of Efficacy and Safety of SJE-2079 in the Treatment for Diabetic Macular Edema

Acronym

Efficacy and Safety of SJE-2079 for Diabetic Macular Edema

Scientific Title

Phase II study of Efficacy and Safety of SJE-2079 in the Treatment for Diabetic Macular Edema

Scientific Title:Acronym

Efficacy and Safety of SJE-2079 for Diabetic Macular Edema

Region

Japan


Condition

Condition

Diabetic macular edema (DME)

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and safety of SJE-2079 comparing vehicle in the treatment for diabetic macular edema

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Mean change from baseline in retinal central foveal thickness using optical coherence tomography (OCT)

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

SJE-2079 BID group: One drop of SJE-2079 instilled in the affected eye(s) twice a day, and 1 drop of vehicle instilled in the same eye(s) twice a day.

Interventions/Control_2

SJE-2079 QID group: One drop of SJE-2079 instilled in the affected eye(s) 4 times a day.

Interventions/Control_3

Vehicle group: One drop of vehicle instilled in the affected eye(s) 4 times a day.

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

1)Diagnosis of type 2 diabetes mellitus
2)Non-proliferative diabetic retinopathy for study eyes
3)Best corrected visual acuity in the efficacy evaluation-intended eye of 30-80 EDTRS letters
4)OCT retinal thickness at center point in the efficacy evaluation-intended eye of >=350 microns

Key exclusion criteria

1)Active and serious retinal disease
2)History of steroid-induced elevation of IOP
3)Any active ocular disease other than diabetic retinopathy
4)HbA1c of >=10.0%
5)Instillation of any corticosteroid, nonsteroidal anti-inflammatory drug or carbonic anhydrase inhibitor within 4 weeks
6)Systemic administration of any corticosteroid within 4 weeks
7)Macular photocoagulation, injection of corticosteroid or any affective drug into the vitreous, sub-tenon capsule and sub-conjunctiva, vitreous surgery, hyperbaric oxygen therapy, stellate ganglion block, cataract surgery or other intraocular surgery within 24 weeks
8)Retinal photocoagulation except macular area within 4 weeks

Target sample size

150


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tadashi Terai

Organization

Senju Pharmaceutical co.,ltd.

Division name

Clinical Development Div.

Zip code


Address

2-5-8,Hirano-machi, Chuo-ku, Osaka

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Senju Pharmaceutical co.,ltd.

Division name

Clinical Development Div.

Zip code


Address


TEL


Homepage URL


Email



Sponsor or person

Institute

Clinical Development Div., Senju Pharmaceutical co.,ltd.

Institute

Department

Personal name



Funding Source

Organization

Senju Pharmaceutical co.,ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor

None

Name of secondary funder(s)

None


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

2011 Year 05 Month 31 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

2010 Year 08 Month 03 Day

Date of IRB


Anticipated trial start date

2010 Year 10 Month 01 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

2011 Year 05 Month 26 Day

Last modified on

2012 Year 07 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005566


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name