Status:
COMPLETED
Safety and Efficacy Study of Dexamethasone Versus Ranibizumab in Patients With Diabetic Macular Edema
Lead Sponsor:
Allergan
Conditions:
Macular Edema
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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).
Eligibility Criteria
Inclusion
- Diagnosis of type 1 or 2 diabetes mellitus
- Diagnosis of macular edema
- Visual acuity between 20/200 to 20/40
Exclusion
- 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
Key Trial Info
Start Date :
March 9 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 13 2014
Estimated Enrollment :
363 Patients enrolled
Trial Details
Trial ID
NCT01492400
Start Date
March 9 2012
End Date
February 13 2014
Last Update
April 17 2019
Active Locations (13)
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1
Arlington, Texas, United States
2
Brussels, Belgium
3
Copenhagen, Denmark
4
Glostrup Municipality, Denmark