Diabetic macula edema
Conditions
Interventions
Kallidinogenase(+)oral
Kallidinogenase(-)
Sponsors
Department of Ophthalmology,Hirosima University School of Medicine
Saneikai Tsukazaki Hospital Ophthalmology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients underwent vitrectomy for diabetic macula edema,who met the all inclusion criteria. (a)Older than 20tears of age at the time of the acquisition agreement. (b)Allowed to go to the Hiroshima University Hospital regularly for one year. (c)Obtained consentin written foem of the study participants.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Foveal retinal thickness | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Japan
Contacts
Public ContactZaigen Ohara
Saneikai Tsukazaki Hospital Ophthalmology
Outcome results
None listed