Diabetic Macular edema
Conditions
Interventions
This is a 6 months, prospective, interventional, exploratory, consecutive case series study, and followed by 6 months extension. Patients receive ranibizumab once a month during first two months.
Initial responder"
and "
Initial non-responder"
. Initial responder is defined that an improvement of more than 5 letters in BCVA or a decrease of at least 20% in CRT from baseline. 1)Initial responder: After three monthly injections, ranibizu
250um). After that, the injection is continued pro re nata (PRN) regimen. (Retreatment criteria of intravitreal ranibizumab is CRT=>
250um) 2)Initial non-responder: After three consecutive monthly injections, FA is performed to clarify the vascular leak from microaneurysm close to macula edema or avascular area at Month 3 visit.
initial responder"
. Otherwise, if focal laser is not applicable to the regions based on the examinations, patients receive ranibizumab injections by similar manner in "
. Focal laser treatment is able to be performed at intervals no shorter than 3 months from the first focal laser. Laser condition: power80-100mA, spot size 50-100um, duration 0.1second, Area Cent
Sponsors
Yamaguchi University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) patients who have diabetes, and have developed in at least one eye diabetic macular edema Patients 2) does not recognize the acute myocardial infarction and cerebral infarction within the onset 3 months Patient age is greater than or equal to 20 years of age at the time of 3) obtaining informed consent 4) gender unquestioned 5) After having received a sufficient explanation Upon participation in the present study, patients on the full understanding, the document agreed by the free will of the patient himself was obtained 6) hospitalization, outpatient unquestioned
Exclusion criteria
Exclusion criteria: 1) Patients with a treatment history of anti VEGF drugs patients 2) Patients with infection or infection suspictions in the eye or around the eye 3) Patients with severe inflammation in the eye 4) DME disease duration is more than 12 months 5) Patients who underwent direct photocoagulation to 3 months in DME within 1000um from the fovea 6) Patients who underwent triamcinolone acetonide subtenon injection or triamcinolone acetonide intravitreal injectionwithin 3 months 7) Patients who underwent PRP within 6 months 8) HbA1c is over 10.0% 9) Poor control of hypertension 10) Eye surgery within 6 months 11) ranibizumab or to the components of other anti-VEGF drugs, those with a history of hypersensitivity 12) Pregnancy, in nursing 13) Other, patient research responsibility who is determined to be unsuitable as research subjects
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The mean change from baseline in best corrected visual acuity (BCVA) at 6 month | — |
Secondary
| Measure | Time frame |
|---|---|
| The mean change from baseline in central retinal thickness (CRT) based on SD-OCT at 6 month. The number of injections, and the number of laser treatment at 6 month. | — |
Countries
Japan
Contacts
Public ContactKazuhiro Kimura
Department of Ophthalmology, Yamaguchi University Graduate School of Medicine opthalmology
Outcome results
None listed