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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT00658619
First received: April 11, 2008
Last updated: March 13, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Macular Degeneration
 Drug: 400 µg Brimonidine Tartrate Implant
Drug: 200 µg Brimonidine Tartrate Implant
Other: Sham (no implant)
 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
Official Title: Safety and Efficacy of Brimonidine Intravitreal Implant in Patients With Geographic Atrophy Due to AMD

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:
  • Change From Baseline in Size of Geographic Atrophy Lesion Area in the Study Eye [ Time Frame: Baseline, Month 12 ] [ Designated as safety issue: No ]
    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 = 2.54 millimeters squared (mm^2).


Secondary Outcome 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 ] [ Designated as safety issue: No ]
    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 = 2.54 millimeters squared (mm^2).

  • Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye [ Time Frame: Baseline, 24 Months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 119
Study Start Date: May 2008
Study Completion Date: April 2011
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 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®
Other: Sham (no implant)
Sham in one or both eyes on Day 1 and Month 6.
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.
 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 2
Stage 2: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
 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®
Other: Sham (no implant)
Sham in one or both eyes on Day 1 and Month 6.
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.
 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.
Sham Comparator: Sham (no implant) Stage 2
Stage 2: sham in both eyes on Day 1 and Month 6.
 Other: Sham (no implant)
Sham in one or both eyes on Day 1 and Month 6.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00658619

Locations
United States, Texas
Abilene, Texas, United States
Australia, New South Wales
Sydney, New South Wales, Australia
Germany
Karlsruhe, Germany
Italy
Udine, Italy
Korea, Republic of
Seoul, Korea, Republic of
Philippines
Makati City, Philippines
Portugal
Coimbra, Portugal
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00658619     History of Changes
Other Study ID Numbers: 190342-032D
Study First Received: April 11, 2008
Results First Received: March 13, 2013
Last Updated: March 13, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Macular Degeneration
Atrophy
Geographic Atrophy
Retinal Degeneration
Retinal Diseases
Eye Diseases
Pathological Conditions, Anatomical
Brimonidine
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
 Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013