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

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 Overview

• Status: Completed
• Conditions: Diabetic Macular Edema; Vitrectomy
• Intervention / Treatment: Drug: Dexamethasone

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Sydney, New South Wales, Australia
• United States
  • North Carolina
    • Charlotte, North Carolina, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 700 µg Dexamethasone Implant; 700 µg dexamethasone implant in the study eye at Day 1	Drug: Dexamethasone; 700 µg Dexamethasone Posterior Segment Drug Delivery System Applicator System at Day 1 in the study eye.; Other Names: Posurdex®; OZURDEX®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, Week 26

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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%).	Baseline, Week 26

Collaborators and Investigators

• Sponsor: Allergan

Publications and helpful links

General Publications

• Boyer DS, Faber D, Gupta S, Patel SS, Tabandeh H, Li XY, Liu CC, Lou J, Whitcup SM; Ozurdex CHAMPLAIN Study Group. Dexamethasone intravitreal implant for treatment of diabetic macular edema in vitrectomized patients. Retina. 2011 May;31(5):915-23. doi: 10.1097/IAE.0b013e318206d18c.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2009
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: November 26, 2008
• First Submitted That Met QC Criteria: November 26, 2008
• First Posted (Estimate): November 27, 2008

Study Record Updates

• Last Update Posted (Actual): April 23, 2019
• Last Update Submitted That Met QC Criteria: April 10, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Macular Edema; Edema; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone
• Other Study ID Numbers: 206207-018