NCT01492400

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 363 (actual)
• Sponsor: Allergan · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Macular Edema

Interventions

Type	Name	Description
DRUG	dexamethasone Intravitreal Implant	Injection of 700 ug dexamethasone intravitreal implant into the study eye on Day 1, Month 5, and Month 10.
DRUG	ranibizumab	Injection of ranibizumab 0.5 mg into the study eye on Day 1. Patients may receive additional injections on a monthly basis, as needed, for disease progression.

Timeline

• Start date: 2012-03-09
• Primary completion: 2014-02-13
• Completion: 2014-02-13
• First posted: 2011-12-15
• Last updated: 2019-04-17
• Results posted: 2015-01-29

Locations

13 sites across 12 countries: United States, Belgium, Denmark, France, Germany, Israel, Italy, Netherlands, Portugal, South Africa, Spain, United Kingdom