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

Allergan

Status and phase: Completed; Phase 2

Conditions: Macular Edema

Treatments: Drug: dexamethasone Intravitreal Implant; Drug: ranibizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01492400

206207-024

Details and patient eligibility

About

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).

Enrollment: 363 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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363 participants in 2 patient groups

dexamethasone Intravitreal Implant

Experimental group

Description:

Injection of 700 ug dexamethasone intravitreal implant into the study eye on Day 1, Month 5, and Month 10.

Treatment:

Drug: dexamethasone Intravitreal Implant

ranibizumab

Active Comparator group

Description:

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.

Treatment:

Drug: ranibizumab