Ranibizumab Exploratory Study on the Evaluation of the local laser combination therapy to non-reactive group to the diabetic macular edema patients
- Conditions
- Diabetic Macular edema
- Registration Number
- JPRN-UMIN000024208
- Lead Sponsor
- Yamaguchi University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The mean change from baseline in best corrected visual acuity (BCVA) at 6 month
- Secondary Outcome Measures
Name Time Method 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.