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

Glaucoma, Open-Angle Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00693485
• Other study ID #: 190342-030D
• Status: Completed
• Phase: Phase 2
• First received: June 5, 2008
• Last updated: March 13, 2013
• Start date: September 2008
• Est. completion date: August 2011

Study information

• Verified date: March 2013
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: August 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma, Open-Angle

Intervention

Drug:
• 400 ug Brimonidine Implant
400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
• 200 ug Brimonidine Implant
200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
• Sham (no implant)
Sham Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Countries where clinical trial is conducted

United States,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, Month 6	No
Secondary	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.	Baseline, Month 6	No