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

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 Overview

• Status: Completed
• Conditions: Diabetic Macular Edema
• Intervention / Treatment: Drug: Dexamethasone; Procedure: Laser Photocoagulation; Drug: Sham injection

• Study Type: Interventional
• Enrollment (Actual): 253
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Victoria, British Columbia, Canada
• United States
  • California
    • Artesia, California, 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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 700 µg Dexamethasone Implant and Laser Photocoagulation; Initial intravitreal injection of 700 µg dexamethasone with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.	Drug: Dexamethasone; Initial intravitreal injection of 700 µg dexamethasone with up to 1 additional treatment based on re-treatment criteria.; Other Names: Posurdex®; Procedure: Laser Photocoagulation; Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
Sham Comparator: Sham Implant and Laser Photocoagulation; Initial sham injection with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.	Procedure: Laser Photocoagulation; Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.; Drug: Sham injection; Initial sham injection with up to 1 additional treatment based on re-treatment criteria.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, Month 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in 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 in the number of letters read correctly indicates improvement and a decrease in the number of letters read correctly indicates a worsening.	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.	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.	Baseline, Month 12
Time to Retreatment in the Study Eye	Time to retreatment in the study eye is defined as the number of days between the initial treatment and re-treatment with the study medication.	12 Months

Collaborators and Investigators

• Sponsor: Allergan

Publications and helpful links

General Publications

• Callanan DG, Gupta S, Boyer DS, Ciulla TA, Singer MA, Kuppermann BD, Liu CC, Li XY, Hollander DA, Schiffman RM, Whitcup SM; Ozurdex PLACID Study Group. Dexamethasone intravitreal implant in combination with laser photocoagulation for the treatment of diffuse diabetic macular edema. Ophthalmology. 2013 Sep;120(9):1843-51. doi: 10.1016/j.ophtha.2013.02.018. Epub 2013 May 22.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2007
• Primary Completion (Actual): February 8, 2010
• Study Completion (Actual): February 8, 2010

Study Registration Dates

• First Submitted: April 20, 2007
• First Submitted That Met QC Criteria: April 20, 2007
• First Posted (Estimate): April 24, 2007

Study Record Updates

• Last Update Posted (Actual): April 24, 2019
• Last Update Submitted That Met QC Criteria: April 11, 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: 206207-012