NCT02131350CompletedPhase 4
Combination Treatment of Intravitreal Ranibizumab, Focal/Grid Laser and Panretinal Photocoagulation in Patients With Diabetic Macula Edema
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Shinshu University
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- best corrected visual acuity
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Ranibizumab with Photocoagulation
Experimental
Intervention: Photocoagulation (Procedure)
Ranibizumab with Photocoagulation
Experimental
Intervention: Ranibizumab (Drug)
Outcomes
Primary Outcomes
best corrected visual acuity
Time Frame: 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 Outcomes
No secondary outcomes reported
Investigators
Takao Hirano
Department of Ophthalmology Shinshu University School of Medicine
Shinshu University
Study Sites (1)
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