The effect of lallidinogenase for the postoperative retina thickness and visual acuity etc.in diabetic macula edema.
Not Applicable
Completed
- Conditions
- Diabetic macula edema
- Registration Number
- JPRN-UMIN000008437
- Lead Sponsor
- Department of Ophthalmology,Hirosima University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
Not provided
Exclusion Criteria
(a)Sever side effects by the past kallidinogenase preparations. (b)Treated by kallidinogenase within one month of preparation before the start of this drug. (c)HbA1c 10%. (d)Treated with steroids or anti-VEGF drugs(drugs contraindicated in combination) (e)Pregnant and lactating woman or woman who may become pregnant. (f)Any others judged by the doctor in charge to be ineligible for subjects in the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Foveal retinal thickness
- Secondary Outcome Measures
Name Time Method Visual acuity,fundus findings,recurrence of the edema,number of the exaples of aan ophthalmic treatment addition,number of the times of an addition,and period to an addition,the safety assessment(rate of adverse events)