Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Macular Edema
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Drug: Ozurdex intravitreal steroid Other Name: Dexamethasone Intravitreal Implant Drug: Bevacizumab antiVEGF Other Name: AvastinMasking: Single (Outcomes Assessor)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

The aim of this study is to evaluate the clinical outcome after intraocular injections of Ranibizumab or combination of Ranibizumab and Dexamethasone under pro re nata treatment regimen for the patients with Diabetic Macular Edema patients. Mean change of logarithm of the minimal angle of resolution...

The aim of this study is to evaluate the clinical outcome after intraocular injections of Ranibizumab or combination of Ranibizumab and Dexamethasone under pro re nata treatment regimen for the patients with Diabetic Macular Edema patients. Mean change of logarithm of the minimal angle of resolution (logMAR) visual acuity (VA), central foveal thickness (CFT), contrast sensitivity (CS) as well as predictive factors including best-corrected visual acuity (BCVA), vision related questionnaires and various other ocular parameters will be assessed.

Tracking Information

NCT #
NCT04601675
Collaborators
Not Provided
Investigators
Study Chair: Wei He, M.D., Ph.D. He Eye Specialist Hospital, Shenyang. Principal Investigator: Jun Li, M.D., Ph.D. He Eye Specialist Hospital, Shenyang. Study Director: Emmanuel E Pazo, M.D., Ph.D. He Eye Specialist Hospital, Shenyang.