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

Study Overview
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Brief Summary
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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.

Conditions
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Glaucoma, Open-Angle

Intervention / Treatment
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* Drug: 400 ug Brimonidine Implant
* Drug: 200 ug Brimonidine Implant
* Drug: Sham (no implant)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 400 ug Brimonidine Implant<br>400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye. | Drug: 400 ug Brimonidine Implant<br>* 400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.<br>* Other names: Brimonidine Tartrate PS DDS®;|
| Experimental: 200 ug Brimonidine Implant<br>200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye. | Drug: 200 ug Brimonidine Implant<br>* 200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.<br>* Other names: Brimonidine Tartrate PS DDS®;|
| Sham Comparator: Sham (no implant)<br>Sham Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye. | Drug: Sham (no implant)<br>* Sham Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |