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

Phase 2

Completed

• Conditions: Macular Edema
• Interventions: Drug: dexamethasone Intravitreal Implant; Drug: ranibizumab

• Registration Number: NCT01492400
• Lead Sponsor: Allergan

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-12-13
• Study First Submitted QC: 2011-12-13
• Study First Posted: 2011-12-15
• Study Start: 2012-03-09
• Primary Completion: 2014-02-13
• Study Completion: 2014-02-13
• Results First Submitted: 2015-01-21
• Results First Submitted QC: 2015-01-21
• Results First Posted: 2015-01-29
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-09
• Last Update Posted: 2019-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 363

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dexamethasone Intravitreal Implant	dexamethasone Intravitreal Implant	Injection of 700 ug dexamethasone intravitreal implant into the study eye on Day 1, Month 5, and Month 10.
ranibizumab	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.

Primary Outcome Measures

Name	Time	Method
Average Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye	Baseline, 12 Months	BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The average BCVA is calculated across study visits for each patient. A positive number change from baseline indicates an improvement and a negative number change from baseline indicates a worsening.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Foveal Thickness Measured by Optical Coherence Tomography (OCT) in the Study Eye	Baseline, Month 12	OCT is a laser based non-invasive diagnostic system providing high-resolution imaging sections of the fovea (part of the retina) in the study eye after pupil dilation. A negative change from baseline indicates an improvement (less foveal thickness) and a positive change from baseline indicates a worsening (more foveal thickness).
Change From Baseline in Total Area of Macular Leakage in the Study Eye Measured on Fluorescein Angiography (FA)	Baseline, Month 12	FA is a technique for examining the circulation of the retina (and detecting any leakage) using a dye-tracing method. Photographs are taken with a specialized low-power microscope with an attached camera designed to photograph the interior of the eye, including the retina and optic disc. A negative change from baseline indicates a decrease in leakage (improvement) and a positive change from baseline indicates an increase in leakage (worsening).