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

Primary Purpose

Glaucoma, Open-Angle

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
400 ug Brimonidine Implant
200 ug Brimonidine Implant
Sham (no implant)
Sponsored by
Allergan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma, Open-Angle

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

400 ug Brimonidine Implant

200 ug Brimonidine Implant

Sham (no implant)

Arm Description

400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.

200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.

Sham Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.

Outcomes

Primary Outcome Measures

Percentage of Patients With a Visual Field Improvement in the Study Eye
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
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.

Full Information

First Posted
June 5, 2008
Last Updated
March 13, 2013
Sponsor
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT00693485
Brief Title
Safety and Effects of Brimonidine Intravitreal Implant in Patients With Glaucomatous Optic Neuropathy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Open-Angle

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
400 ug Brimonidine Implant
Arm Type
Experimental
Arm Description
400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
Arm Title
200 ug Brimonidine Implant
Arm Type
Experimental
Arm Description
200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
Arm Title
Sham (no implant)
Arm Type
Sham Comparator
Arm Description
Sham Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
Intervention Type
Drug
Intervention Name(s)
400 ug Brimonidine Implant
Other Intervention Name(s)
Brimonidine Tartrate PS DDS®
Intervention Description
400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
Intervention Type
Drug
Intervention Name(s)
200 ug Brimonidine Implant
Other Intervention Name(s)
Brimonidine Tartrate PS DDS®
Intervention Description
200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
Intervention Type
Drug
Intervention Name(s)
Sham (no implant)
Intervention Description
Sham Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
Primary Outcome Measure Information:
Title
Percentage of Patients With a Visual Field Improvement in the Study Eye
Description
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.
Time Frame
Baseline, Month 6
Secondary Outcome Measure Information:
Title
Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
Description
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.
Time Frame
Baseline, Month 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
Artesia
State/Province
California
Country
United States
City
Tel Aviv
Country
Israel

12. IPD Sharing Statement

Learn more about this trial

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

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