Combination Treatment of Intravitreal Ranibizumab, Focal/Grid Laser and Panretinal Photocoagulation in Patients With Diabetic Macula Edema
Phase 4
Completed
- Conditions
- Diabetic Macula Edema
- Interventions
- Procedure: Photocoagulation
- Registration Number
- NCT02131350
- Lead Sponsor
- Shinshu University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Ranibizumab with Photocoagulation Photocoagulation - Ranibizumab with Photocoagulation Ranibizumab -
- Primary Outcome Measures
Name Time Method best corrected visual acuity every month, up to 36 months Best corrected visual acuity is measured with Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and analysed.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Department ou Ophthalmology Shinshu University School of Medicine
🇯🇵Matsumoto, Nagano, Japan