Safety and Efficacy of Brimonidine Intravitreal Implant in Patients With Geographic Atrophy Due to Age-related Macular Degeneration (AMD)

Overview

Stage 1 is a patient-masked, dose-escalation, safety evaluation of brimonidine intravitreal implant. Patients will receive implant in one eye and "sham" treatment (meaning no treatment) in the fellow eye. Stage 2 will begin after 1 month of safety has been evaluated for Stage 1. Stage 2 is a randomized, double-masked, dose-response, sham-controlled evaluation of the safety and efficacy of brimonidine intravitreal implant in patients with geographic atrophy from age-related macular degeneration. Patients will be followed for up to 2 years.

Full Title of Study: “Safety and Efficacy of Brimonidine Intravitreal Implant in Patients With Geographic Atrophy Due to AMD”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Outcomes Assessor)
  • Study Primary Completion Date: June 1, 2010

Interventions

  • Drug: 400 µg Brimonidine Tartrate Implant
    • 400 µg brimonidine tartrate implant in the study eye on Day 1 and Month 6.
  • Drug: 200 µg Brimonidine Tartrate Implant
    • 200 µg brimonidine tartrate implant in the study eye on Day 1 and Month 6.
  • Other: Sham (no implant)
    • Sham in one or both eyes on Day 1 and Month 6.

Arms, Groups and Cohorts

  • Other: 400 µg Brimonidine Tartrate Implant Stage 1
    • Stage 1: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
  • Other: 200 µg Brimonidine Tartrate Implant Stage 1
    • Stage 1: 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
  • Other: 400 µg Brimonidine Tartrate Implant Stage 2
    • Stage 2: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
  • Other: 200 µg Brimonidine Tartrate Implant Stage 2
    • Stage 2: 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
  • Sham Comparator: Sham (no implant) Stage 2
    • Stage 2: sham in both eyes on Day 1 and Month 6.

Clinical Trial Outcome Measures

Primary Measures

  • Change From Baseline in Size of Geographic Atrophy Lesion Area in the Study Eye
    • Time Frame: Baseline, Month 12
    • Change from baseline in size of geographic atrophy lesion area in the study eye is based on fundus photography as read by an independent Reading Center. Photographs are taken with a specialized microscope with an attached camera to photograph the interior of the eye, including the retina and optic disc. A positive change from baseline indicates an increase in size of geographic atrophy lesion area (worsening; disease progression). Data are reported in disc area where 1 disc area = 1.767 millimeters squared (mm^2).

Secondary Measures

  • Change From Baseline in Size of Geographic Atrophy Lesion Area in the Study Eye
    • Time Frame: Baseline, Month 3, Month 6, Month 9, Month 18, Month 24
    • Change from baseline in size of geographic atrophy lesion area in the study eye is based on fundus photography as read by an independent Reading Center. Photographs are taken with a specialized microscope with an attached camera to photograph the interior of the eye, including the retina and optic disc. A positive change from baseline indicates an increase in size of geographic atrophy lesion area (worsening; disease progression). Data are reported in disc area where 1 disc area = 1.767 millimeters squared (mm^2).
  • Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
    • Time Frame: Baseline, 24 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). A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening.
  • Change From Baseline in Contrast Sensitivity in the Study Eye
    • Time Frame: Baseline, 24 Months
    • Change from baseline in contrast sensitivity in the study eye is measured using a Pelli-Robson contrast sensitivity chart at 1 meter. The contrast sensitivity chart contains letters that are darkest at the top and then get progressively lighter. Scores range from 0 to 48 and are based on the number of letters read correctly. A negative change from baseline indicates a worsening in contrast sensitivity and a positive change from baseline indicates an improvement.
  • Change From Baseline in Reading Speed in the Study Eye
    • Time Frame: Baseline, 24 Months
    • Change from baseline in reading speed in the study eye is assessed using modified Bailey-Lovie word charts. Patients read the chart for 2 minutes and the numbers of words read correctly per minute are totaled. An increase in the number of words read correctly indicates an improvement and a decrease in the number of words read correctly indicates a worsening.

Participating in This Clinical Trial

Inclusion Criteria

  • Geographic atrophy in both eyes due to age-related macular degeneration
  • Visual acuity between 20/40 to 20/320

Exclusion Criteria

  • Known allergy to brimonidine
  • Uncontrolled systemic disease or infection of the eye
  • Recent eye surgery or injections in the eye
  • Female patients who are pregnant, nursing or planning a pregnancy

Gender Eligibility: All

Minimum Age: 50 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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