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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00464685
Recruitment Status : Completed
First Posted : April 24, 2007
Results First Posted : August 4, 2014
Last Update Posted : April 24, 2019
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetic Macular Edema Drug: Dexamethasone Drug: Sham injection Procedure: Laser Photocoagulation Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 253 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Actual Study Start Date : May 1, 2007
Actual Primary Completion Date : February 8, 2010
Actual Study Completion Date : February 8, 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arms and Interventions
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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 Name: 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.
 Drug: Sham injection
Initial sham injection with up to 1 additional treatment based on re-treatment criteria.

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


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Patients With at Least 10 Letters of Improvement in Best Corrected Visual Acuity (BCVA) From Baseline in the Study Eye [ Time Frame: Baseline, Month 12 ]
    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.


Secondary Outcome Measures :
  1. Change From Baseline in BCVA in the Study Eye [ Time Frame: Baseline, Month 12 ]
    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.

  2. Change From Baseline in Central Subfield Retinal Thickness in the Study Eye [ Time Frame: Baseline, Month 12 ]
    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.

  3. Change From Baseline in the Focal Leakage Area in the Study Eye [ Time Frame: Baseline, Month 12 ]
    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.

  4. Time to Retreatment in the Study Eye [ Time Frame: 12 Months ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00464685


Locations
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United States, California
Artesia, California, United States
Canada, British Columbia
Victoria, British Columbia, Canada
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Medical Director Allergan
More Information
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Publications:

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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00464685    
Other Study ID Numbers: 206207-012
First Posted: April 24, 2007    Key Record Dates
Results First Posted: August 4, 2014
Last Update Posted: April 24, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
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Macular Edema
Edema
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Dexamethasone
Anti-Inflammatory Agents
Antiemetics
 Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents