Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment Phase
Macular Degeneration Drug: 400 µg Brimonidine Tartrate Implant Drug: 200 µg Brimonidine Tartrate Implant Other: Sham (no implant) Phase 2

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 119 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Brimonidine Intravitreal Implant in Patients With Geographic Atrophy Due to AMD
Actual Study Start Date : May 1, 2008
Actual Primary Completion Date : June 1, 2010
Actual Study Completion Date : April 8, 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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).

  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.

  3. 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.

  4. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00658619


Locations
Layout table for location information
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
Layout table for investigator information
Study Director: Medical Director Allergan
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00658619    
Other Study ID Numbers: 190342-032D
First Posted: April 15, 2008    Key Record Dates
Results First Posted: April 26, 2013
Last Update Posted: August 21, 2018
Last Verified: July 2018
Additional relevant MeSH terms:
Layout table for MeSH terms
Macular Degeneration
Geographic Atrophy
Atrophy
Retinal Degeneration
Retinal Diseases
Eye Diseases
Pathological Conditions, Anatomical
Brimonidine Tartrate
 Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs