Safety and Efficacy Study of Dexamethasone Versus Ranibizumab in Patients With Diabetic Macular Edema

Completed · Phase 2

Conditions studied: Macular Edema

In brief

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).

Key facts

Study ID

NCT01492400

Run by

Allergan

People needed

363

Starts

2012-03-09

Expected to finish

2014-02-13

Last updated by the study team

2019-04-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of type 1 or 2 diabetes mellitus
• Diagnosis of macular edema
• Visual acuity between 20/200 to 20/40

You may not qualify if…

• 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

Where it is running

• Study site — Arlington, Texas, United States
• Study site — Brussels, Belgium
• Study site — Copenhagen, Denmark
• Study site — Glostrup Municipality, Denmark
• Study site — Paris, France
• Study site — Ahaus, Germany
• Study site — Tel Aviv, Israel
• Study site — Udine, Italy
• Study site — Nijmegen, Netherlands
• Study site — Coimbra, Portugal
• Study site — Pretoria, South Africa
• Study site — Barcelona, Spain
• Study site — London, England, United Kingdom

Full record on ClinicalTrials.gov

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