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

• Status: Completed
• Trial end date: 2014-02-13
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Allergan
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Ranibizumab

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