Working...
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

Tracking Information
First Submitted Date  ICMJE June 5, 2008
First Posted Date  ICMJE June 9, 2008
Results First Submitted Date  ICMJE March 13, 2013
Results First Posted Date  ICMJE April 24, 2013
Last Update Posted Date April 24, 2013
Study Start Date  ICMJE September 2008
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 13, 2013)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 5, 2008)
Change in visual acuity [ Time Frame: Month 6 ]
Change History Complete list of historical versions of study NCT00693485 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 13, 2013)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 5, 2008)
Change in visual fields [ Time Frame: Day 1 - Month 12 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Effects of Brimonidine Intravitreal Implant in Patients With Glaucomatous Optic Neuropathy
Official Title  ICMJE Not Provided
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Glaucoma, Open-Angle
Intervention  ICMJE
  • 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®
  • 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®
  • Drug: Sham (no implant)
    Sham Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
Study Arms  ICMJE
  • Experimental: 400 ug Brimonidine Implant
    400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
    Intervention: Drug: 400 ug Brimonidine Implant
  • Experimental: 200 ug Brimonidine Implant
    200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
    Intervention: Drug: 200 ug Brimonidine Implant
  • Sham Comparator: Sham (no implant)
    Sham Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
    Intervention: Drug: Sham (no implant)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 18, 2011)
70
Original Estimated Enrollment  ICMJE
 (submitted: June 5, 2008)
60
Actual Study Completion Date  ICMJE August 2011
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00693485
Other Study ID Numbers  ICMJE 190342-030D
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Allergan
Study Sponsor  ICMJE Allergan
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Allergan
PRS Account Allergan
Verification Date March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP