| Registry | NCT02131350 |
|---|---|
| Status | Completed |
| Phase | Phase 4 |
| Study type | Interventional; na, single group, masking: none, treatment |
| Enrollment | 40 (Actual) |
| Sponsor | Shinshu University (Other) |
| Conditions | Diabetic Macula Edema |
| Interventions | Photocoagulation, Ranibizumab (Procedure, drug) |
| Dates | start 2014-04-01, primary completion 2017-03-01, completion 2018-03-01, first posted 2014-05-06, last updated 2018-09-07 |
| Locations | 1 site in Japan |
Related Papers Related Patents Related Grants Related Experts
All trials for Diabetic Macula Edema All trials of Photocoagulation All trials of Ranibizumab
The purpose of this study is to evaluate the mean gain in best corrected visual acuity and the number of intravitreal ranibizumab (IVR) injections under the combination treatment of IVR, focal/grid laser and panretinal photocoagulation. Our hypothesis is that suitable photocoagulation decreases the number of IVR injections.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Ranibizumab with Photocoagulation | Experimental | Procedure: Photocoagulation; Drug: Ranibizumab |
Sex: All, ages: 20 Years to any
Inclusion Criteria: * stable medication for the management of diabetes within 3 months * visual impairment due to focal or diffuse diabetic macula edema * decreased vision due to diabetic macula edema and not other causes Exclusion Criteria: * concomitant conditions in the study eye that could prevent the improvement in VA on the study * active intraocular inflammation or infection in either eye * uncontrolled glaucoma in either eye * treatment with antiangiogenic drugs in the study eye within 3 months * history of stroke and uncontrolled hypertension
| Facility | City | Country | Status |
|---|---|---|---|
| Department ou Ophthalmology Shinshu University School of Medicine | Matsumoto, Nagano | Japan |