Safety and Efficacy of Brimonidine Tartrate Posterior Segment Drug Delivery System in Improving Visual Function

Study Overview
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Brief Summary
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This study will evaluate the efficacy and safety of the Brimo PS DDS® Applicator System (200 μg and 400 μg brimonidine tartrate) on visual function in patients with previous rhegmatogenous macula-off retinal detachment.

Conditions
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Rhegmatogenous Macula-off Retinal Detachment

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The macula-off retinal detachment must have been caused by a rupture (rhegmatogenous in etiology) The repair of the macula-off retinal detachment must have occurred at least 6 months before the Day 1 visit in the study eye The repair must have been deemed an anatomic success and required no more than one macular re-attachment procedure The visual acuity score must be between 20/50 and 20/320 in the study eye Exclusion Criteria: Any sight-threatening ocular condition in the study eye other than the ruptured retinal detachment Anticipated need for ocular surgery during the 12-month study period Any injectable, periocular, or intravitreal corticosteroid treatment to study eye within 6 months prior to screening (eg, triamcinolone acetonide) Any injectable, periocular, or intravitreal anti-VEGF treatment to the study eye within 3 months prior to screening (eg, Avastin or Lucentis) Any infectious condition in the study eye

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 on Day 1 in the study eye. | Drug: 400 ug Brimonidine Implant<br>* 400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.<br>* Other names: Brimonidine Tartrate PS DDS®;|
| Experimental: 200 ug Brimonidine Implant<br>200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye. | Drug: 200 ug Brimonidine Implant<br>* 200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.<br>* Other names: Brimonidine Tartrate PS DDS®;|
| Sham Comparator: Sham (no implant)<br>Sham Posterior Segment Drug Delivery system on Day 1 in the study eye. | Other: Sham (no implant)<br>* Sham Posterior Segment Drug Delivery system on Day 1 in the 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 at Least a 15-Letter Increase 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). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly indicates that vision has improved. The percentage of patients with at least a 15-letter increase in BCVA in the study eye is reported. | Month 3 | 

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 3 |