Safety and Efficacy Study of Dexamethasone Versus Ranibizumab in Patients With Diabetic Macular Edema
ClinicalTrials.gov ID
NCT01492400
Lead Sponsor
AllerganINDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Phase 2
Enrollment
363Actual
Last Update Posted
Apr 17, 2019Actual
Start Date
Mar 9, 2012Actual
Primary Completion Date
Feb 13, 2014Actual
Completion Date
Feb 13, 2014Actual
Brief Summary
This study will compare the safety and efficacy of the 700 ug dexamethasone intravitreal implant with ranibizumab 0.5 mg intravitreal injections in patients with diabetic macular edema (DME).
Macular Edema
dexamethasone Intravitreal Implant
ranibizumab
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of type 1 or 2 diabetes mellitus
Diagnosis of macular edema
Visual acuity between 20/200 to 20/40
Exclusion Criteria:
Eye surgery to the study eye within 3 months
Use of Ozurdex® within 9 months
Any active ocular inflammation and infection
Diagnosis of glaucoma
Use of anti-VEGF treatment (e.g., Lucentis®) within 3 months in the eye or systemic use (e.g., Avastin®) within 6 months