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

Shinshu University1 site in 1 country40 target enrollmentApril 2014

ConditionsDiabetic Macula Edema

InterventionsPhotocoagulation Ranibizumab

DrugsRanibizumab

Overview

Phase: Phase 4
Intervention: Photocoagulation
Conditions: Diabetic Macula Edema
Sponsor: Shinshu University
Enrollment: 40
Locations: 1
Primary Endpoint: best corrected visual acuity
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

April 2014

End Date

March 2018

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Shinshu University

Responsible Party

Principal Investigator

Takao Hirano

Department of Ophthalmology Shinshu University School of Medicine

Shinshu University

Eligibility Criteria

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