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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00693485
First Posted: June 9, 2008
Last Update Posted: April 24, 2013
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.
Information provided by (Responsible Party):
Allergan
  Purpose
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 Intervention Phase
Glaucoma, Open-Angle Drug: 400 ug Brimonidine Implant Drug: 200 ug Brimonidine Implant Drug: Sham (no implant) Phase 2

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

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • 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:
  • 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.


Enrollment: 70
Study Start Date: September 2008
Study Completion Date: August 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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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
  Contacts and Locations
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
  More Information

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00693485     History of Changes
Other Study ID Numbers: 190342-030D
First Submitted: June 5, 2008
First Posted: June 9, 2008
Results First Submitted: March 13, 2013
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


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