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

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ClinicalTrials.gov Identifier: NCT00658619
Recruitment Status : Completed
First Posted : April 15, 2008
Results First Posted : April 26, 2013
Last Update Posted : August 21, 2018
Sponsor:
Information provided by (Responsible Party):
Allergan

April 11, 2008
April 15, 2008
March 13, 2013
April 26, 2013
August 21, 2018
May 1, 2008
June 1, 2010   (Final data collection date for primary outcome measure)
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).
Change from baseline in size of geographic atrophy based on the stereoscopic color fundus photography and fluorescein angiography. [ Time Frame: Month 12 ]
Complete list of historical versions of study NCT00658619 on ClinicalTrials.gov Archive Site
  • 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.
  • Visual acuity [ Time Frame: Day 1 - Month 24 ]
  • Contrast sensitivity [ Time Frame: Day 1 - Month 24 ]
  • Reading speed [ Time Frame: Day 1 - Month 24 ]
  • Patient questionnaires [ Time Frame: Day 1 - Month 24 ]
Not Provided
Not Provided
 
Safety and Efficacy of Brimonidine Intravitreal Implant in Patients With Geographic Atrophy Due to Age-related Macular Degeneration (AMD)
Safety and Efficacy of Brimonidine Intravitreal Implant in Patients With Geographic Atrophy Due to AMD
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Macular Degeneration
  • Drug: 400 µg Brimonidine Tartrate Implant
    400 µg brimonidine tartrate implant in the study eye on Day 1 and Month 6.
    Other Name: Brimonidine Tartrate PS DDS®
  • Drug: 200 µg Brimonidine Tartrate Implant
    200 µg brimonidine tartrate implant in the study eye on Day 1 and Month 6.
    Other Name: Brimonidine Tartrate PS DDS®
  • Other: Sham (no implant)
    Sham in one or both eyes on Day 1 and Month 6.
  • 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.
    Interventions:
    • Drug: 400 µg Brimonidine Tartrate Implant
    • Other: Sham (no implant)
  • 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.
    Interventions:
    • Drug: 200 µg Brimonidine Tartrate Implant
    • Other: Sham (no implant)
  • 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.
    Interventions:
    • Drug: 400 µg Brimonidine Tartrate Implant
    • Other: Sham (no implant)
  • 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.
    Interventions:
    • Drug: 200 µg Brimonidine Tartrate Implant
    • Other: Sham (no implant)
  • Sham Comparator: Sham (no implant) Stage 2
    Stage 2: sham in both eyes on Day 1 and Month 6.
    Intervention: Other: Sham (no implant)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
119
95
April 8, 2011
June 1, 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
50 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Germany,   Italy,   Korea, Republic of,   Philippines,   Portugal,   United States
 
 
NCT00658619
190342-032D
No
Not Provided
Not Provided
Allergan
Allergan
Not Provided
Study Director: Medical Director Allergan
Allergan
July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP