An Exploratory Study to Evaluate the Safety of Brimonidine Intravitreal Implant in Patients With Retinitis Pigmentosa

Study Overview
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Brief Summary
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This exploratory, 12-month, ascending-dose study will evaluate the safety and effects on visual function of a single injection of Brimonidine intravitreal implant in one eye of patients with Retinitis Pigmentosa.

Conditions
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Retinitis Pigmentosa

Intervention / Treatment
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* Drug: 400 µg Brimonidine Tartrate Implant
* Drug: 200 µg Brimonidine Tartrate Implant
* Drug: 100 µg Brimonidine Tartrate Implant
* Other: Sham (no implant)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Retinitis Pigmentosa in both eyes Visual acuity between 20/40 to count fingers Exclusion Criteria: Growth of new blood vessels in the eye Any intraocular surgery or laser in either eye in the last 6 months prior to Screening visit or between the Screening visit and Day 1 Any ocular disease that can interfere with diagnosis and or assessment of disease progression Significant near-sightedness HIV Female patients who are pregnant, nursing, or planning 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 400 µg Brimonidine Tartrate Implant Group B<br>400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1. | Drug: 400 µg Brimonidine Tartrate Implant<br>* 400 µg brimonidine tartrate implant in the study eye on Day 1.<br>* Other names: Brimonidine Tartrate PS DDS®;Other: Sham (no implant)<br>* Sham in the fellow eye on Day 1.<br>|
| Experimental: 200 µg Brimonidine Tartrate Implant Group B<br>200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1. | Drug: 200 µg Brimonidine Tartrate Implant<br>* 200 µg brimonidine tartrate implant in the study eye on Day 1.<br>* Other names: Brimonidine Tartrate PS DDS®;Other: Sham (no implant)<br>* Sham in the fellow eye on Day 1.<br>|
| Experimental: 100 µg Brimonidine Tartrate Implant Group B<br>100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1. | Drug: 100 µg Brimonidine Tartrate Implant<br>* 100 µg brimonidine tartrate implant in the study eye on Day 1.<br>* Other names: Brimonidine Tartrate PS DDS®;Other: Sham (no implant)<br>* Sham in the fellow eye on Day 1.<br>|
| Experimental: 100 µg Brimonidine Tartrate Implant Group A<br>100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1. | Drug: 100 µg Brimonidine Tartrate Implant<br>* 100 µg brimonidine tartrate implant in the study eye on Day 1.<br>* Other names: Brimonidine Tartrate PS DDS®;Other: Sham (no implant)<br>* Sham in the fellow eye on Day 1.<br>|

What is the study measuring?
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Primary 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Contrast Sensitivity in the Study Eye | Change from baseline in contrast sensitivity in the study eye is measured using a Pelli-Robson contrast sensitivity chart at 1 meter. The contrast sensitivity chart contains letters that are darkest at the top and then get progressively lighter. Scores range from 0 to 48 and are based on the number of letters read correctly. A negative change from baseline indicates a worsening in contrast sensitivity and a positive change from baseline indicates an improvement. | Baseline, Month 6 |