Safety and Efficacy of a New Treatment in Vitrectomized Subjects With Diabetic Macular Edema

Allergan56 enrolled

Overview

The study will evaluate the safety and efficacy of the intravitreal dexamethasone implant in the study eye of vitrectomized subjects with diabetic macular edema. Subjects will be followed for 26 weeks.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetic Macular Edema Vitrectomy

Interventions

DexamethasoneDRUG

700 µg Dexamethasone Posterior Segment Drug Delivery System Applicator System at Day 1 in the study eye.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 18 years of age or older with diabetic macular edema * History of vitrectomy * Central retinal thickness ≥ 275 µm * Visual acuity between 20/320 and 20/40 in the study eye and no worse than 20/200 in the other eye Exclusion Criteria: * Known anticipated need for ocular surgery during the study period * History of glaucoma or current high eye pressure requiring more than 1 medication * Uncontrolled systemic disease * Known allergy to the study medication * Known steroid-responder * Use of systemic steroids * Female subjects that are pregnant, nursing or planning a pregnancy

Locations (2)

Unnamed facility

Charlotte, North Carolina, United States

Unnamed facility

Sydney, New South Wales, Australia

Outcomes

Primary Outcomes

Change From Baseline in Central Retinal Thickness in the Study Eye

Central retinal thickness is assessed in the study eye by Optical Coherence Tomography (OCT). 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 change from baseline in retinal thickness indicates an improvement and a positive change from baseline indicates a worsening.

Time frame: Baseline, Week 26

Secondary Outcomes

Change From Baseline in Best Corrected Visual Acuity (BCVA) 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 from baseline in the number of letters read correctly indicates improvement and a decrease from baseline in the number of letters read correctly indicates a worsening.

Time frame: Baseline, Week 26

Percentage of Patients With at Least 10 Letters of Improvement in 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, Week 26

Percentage of Patients With Fluorescein Leakage as Measured by Fluorescein Angiography (FA) in the Study Eye

Fluorescein leakage is measured in the study eye by FA. FA is a technique for examining the circulation of the retina (and detecting any leakage) using a dye-tracing method. The assessment of fluorescein leakage compared to baseline is categorized as Improved (leakage area decreased ≥ 10%), Unchanged (leakage area changed \< 10%), and Worsened (leakage area increased ≥ 10%).

Data from ClinicalTrials.gov

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