Safety and Efficacy of a New Treatment in Combination With Laser for Diabetic Macular Edema

Allergan253 enrolled

Overview

This study will evaluate the safety and efficacy of the intravitreal implant of dexamethasone with laser treatment vs. laser treatment alone in patients with diabetic macular edema.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

253

Conditions

Diabetic Macular Edema

Interventions

DexamethasoneDRUG

Initial intravitreal injection of 700 µg dexamethasone with up to 1 additional treatment based on re-treatment criteria.

Sham injectionDRUG

Initial sham injection with up to 1 additional treatment based on re-treatment criteria.

Laser PhotocoagulationPROCEDURE

Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 18 years of age or older with diabetic macular edema * Decrease in visual acuity in at least one eye as a result of macular edema (20/50 or worse) * Visual acuity in other eye no worse than 20/200 Exclusion Criteria: * Known anticipated need for ocular surgery within next 12 months * History of glaucoma or current high eye pressure requiring more than 1 medication * Uncontrolled systemic disease * Known steroid-responder * Use of systemic steroids - Use of Warfarin/Heparin

Locations (2)

Unnamed facility

Artesia, California, United States

Unnamed facility

Victoria, British Columbia, Canada

Outcomes

Primary Outcomes

Percentage of Patients With at Least 10 Letters of Improvement in Best Corrected Visual Acuity (BCVA) From Baseline in the Study Eye

BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly indicates improvement and a decrease in the number of letters read correctly indicates a worsening.

Time frame: Baseline, Month 12

Secondary Outcomes

Change From Baseline in BCVA in the Study Eye

Time frame: Baseline, Month 12

Change From Baseline in Central Subfield Retinal Thickness in the Study Eye

Central subfield retinal thickness is assessed in the study eye by Optical Coherence Tomography (OCT). The central subfield is an area in the retina (back of the eye). OCT is a laser-based, noninvasive, diagnostic system that provides high-resolution, three-dimensional images of the retina from which retinal thickness can be measured. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.

Time frame: Baseline, Month 12

Change From Baseline in the Focal Leakage Area in the Study Eye

Focal leakage area in the study eye is assessed using fluorescein angiography. A positive number change from baseline indicates a worsening and a negative number change from baseline indicates an improvement.

Time frame: Baseline, Month 12

Data from ClinicalTrials.gov

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