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

Allergan363 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

363

Conditions

Macular Edema

Interventions

dexamethasone Intravitreal ImplantDRUG

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

ranibizumabDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (13)

Unnamed facility

Arlington, Texas, United States

Unnamed facility

Brussels, Belgium

Unnamed facility

Copenhagen, Denmark

Unnamed facility

Glostrup Municipality, Denmark

Outcomes

Primary Outcomes

Average Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye

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.

Time frame: Baseline, 12 Months

Secondary Outcomes

Change From Baseline in Foveal Thickness Measured by Optical Coherence Tomography (OCT) in the Study Eye

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).

Time frame: Baseline, Month 12

Change From Baseline in Total Area of Macular Leakage in the Study Eye Measured on Fluorescein Angiography (FA)

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).

Time frame: Baseline, Month 12

Data from ClinicalTrials.gov

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