ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety and Effects of Brimonidine Intravitreal Implant in Patients With Glaucomatous Optic Neuropathy

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: NCT00693485
Recruitment Status : Completed
First Posted : June 9, 2008
Results First Posted : April 24, 2013
Last Update Posted : April 24, 2013
Sponsor:
Information provided by (Responsible Party):
Allergan

Brief Summary:
A multicenter, randomized, patient-masked, sham-controlled evaluation of the safety and effects on visual function of brimonidine intravitreal implant in patients with glaucomatous optic neuropathy. Patients will be followed for up to 1 year.

Condition or disease Intervention/treatment Phase
Glaucoma, Open-Angle Drug: 400 ug Brimonidine Implant Drug: 200 ug Brimonidine Implant Drug: Sham (no implant) Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : September 2008
Actual Primary Completion Date : January 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 400 ug Brimonidine Implant
400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
Drug: 400 ug Brimonidine Implant
400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
Other Name: Brimonidine Tartrate PS DDS®
Experimental: 200 ug Brimonidine Implant
200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
Drug: 200 ug Brimonidine Implant
200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
Other Name: Brimonidine Tartrate PS DDS®
Sham Comparator: Sham (no implant)
Sham Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
Drug: Sham (no implant)
Sham Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.



Primary Outcome Measures :
  1. Percentage of Patients With a Visual Field Improvement in the Study Eye [ Time Frame: Baseline, Month 6 ]
    Visual field improvement in the study eye is determined using the Humphrey Field Analyzer (HFA 24-2) full threshold test and clinical expertise. The Humphrey Field Analyzer is a machine that helps to map the field (peripheral) of vision. An improvement is an increase in the field of vision. The percentage of patients with a visual field improvement in the study eye is reported.


Secondary Outcome Measures :
  1. Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye [ Time Frame: Baseline, Month 6 ]
    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.



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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Primary open-angle glaucoma in one eye
  • Visual acuity 20/80 or better
  • Intraocular pressure in the study eye ≤ 24 mm Hg
  • Glaucomatous visual field loss - 7 dB to - 25 dB

Exclusion Criteria:

  • Known allergy to brimonidine tartrate
  • 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

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): NCT00693485


Locations
United States, California
Artesia, California, United States
Israel
Tel Aviv, Israel
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00693485     History of Changes
Other Study ID Numbers: 190342-030D
First Posted: June 9, 2008    Key Record Dates
Results First Posted: April 24, 2013
Last Update Posted: April 24, 2013
Last Verified: March 2013

Additional relevant MeSH terms:
Glaucoma, Open-Angle
Glaucoma
Ocular Hypertension
Eye Diseases
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