A Study of the Safety and Efficacy of a New Treatment for Diabetic Macular Edema

Overview

This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of diabetic macular edema.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: May 2012

Interventions

  • Drug: Dexamethasone
    • 350 µg or 700 µg dexamethasone posterior segment drug delivery system – injection into the vitreous cavity not less than every 6 months for up to 36 months.
  • Other: Sham
    • Sham posterior segment drug delivery system-needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.

Arms, Groups and Cohorts

  • Experimental: Dexamethasone 700 μg
    • 700 µg Dexamethasone posterior segment drug delivery system – injection into the vitreous cavity not less than every 6 months for up to 36 months.
  • Experimental: Dexamethasone 350 μg
    • 350 µg Dexamethasone posterior segment drug delivery system – injection into the vitreous cavity not less than every 6 months for up to 36 months.
  • Sham Comparator: Sham
    • Sham posterior segment drug delivery system – needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.

Clinical Trial Outcome Measures

Primary Measures

  • Percentage of Patients With a Best Corrected Visual Acuity (BCVA) Improvement of ≥15 Letters From Baseline in the Study Eye
    • Time Frame: Baseline, Month 39/Final Visit
    • BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. 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 Measures

  • Average Change From Baseline in BCVA in the Study Eye
    • Time Frame: Baseline, 39 Months
    • BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The average BCVA is calculated across study visits for each patient. A positive number change from baseline indicates an improvement and a negative number change from baseline indicates a worsening.
  • Change From Baseline in BCVA in the Study Eye
    • Time Frame: Baseline, Month 39/Final Visit
    • BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A positive number change from baseline indicates an improvement and a negative number change from baseline indicates a worsening.
  • Percentage of Patients With a BCVA Improvement of ≥10 Letters From Baseline in the Study Eye
    • Time Frame: Baseline, Month 39/Final Visit
    • BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. 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 Retinal Thickness as Measured by Optical Coherence Tomography (OCT)
    • Time Frame: Baseline, Month 39/Final Visit
    • 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.

Participating in This Clinical Trial

Key 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 Key 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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Allergan
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Medical Director, Study Director, Allergan

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