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Completed

NCT Number: NCT00464685

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.

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Key information

Conditions

Diabetic Macular Edema

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Victoria, British Columbia, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexamethasone

Drug

Initial intravitreal injection of 700 µg dexamethasone with up to 1 additional treatment based on re-treatment criteria.

Other names: Posurdex®

Sham injection

Drug

Initial sham injection with up to 1 additional treatment based on re-treatment criteria.

Laser Photocoagulation

Procedure

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Apr 24, 2007
Registry last updated
Apr 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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