Combination Treatment of Intravitreal Ranibizumab, Focal/Grid Laser and Panretinal Photocoagulation in Patients With Diabetic Macula Edema

Shinshu University40 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetic Macula Edema

Interventions

PhotocoagulationPROCEDURE

Photocoagulation include focal/grid laser and/or panretinal photocoagulation

RanibizumabDRUG

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (1)

Department ou Ophthalmology Shinshu University School of Medicine

Matsumoto, Nagano, Japan

Outcomes

Primary Outcomes

best corrected visual acuity

Best corrected visual acuity is measured with Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and analysed.

Time frame: every month, up to 36 months

Data from ClinicalTrials.gov

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