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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT00464685
First received: April 20, 2007
Last updated: July 10, 2014
Last verified: July 2014
  Purpose

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 Intervention Phase
Diabetic Macular Edema
Drug: Dexamethasone
Drug: Sham injection
Procedure: Laser Photocoagulation
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • Change From Baseline in BCVA in the Study Eye [ Time Frame: Baseline, Month 12 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Central Subfield Retinal Thickness in the Study Eye [ Time Frame: Baseline, Month 12 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in the Focal Leakage Area in the Study Eye [ Time Frame: Baseline, Month 12 ] [ Designated as safety issue: No ]
    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 to Retreatment in the Study Eye [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    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.


Enrollment: 253
Study Start Date: May 2007
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00464685

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

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00464685     History of Changes
Other Study ID Numbers: 206207-012
Study First Received: April 20, 2007
Results First Received: July 10, 2014
Last Updated: July 10, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Edema
Macular Edema
Eye Diseases
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Signs and Symptoms
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Enzyme Inhibitors
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014