An Exploratory Study to Evaluate the Safety of Brimonidine Intravitreal Implant in Patients With Retinitis Pigmentosa
NCT ID: NCT00661479
Last Updated: 2013-04-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
21 participants
INTERVENTIONAL
2008-07-31
2010-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
SINGLE
Study Groups
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400 µg Brimonidine Tartrate Implant Group B
400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
400 µg Brimonidine Tartrate Implant
400 µg brimonidine tartrate implant in the study eye on Day 1.
Sham (no implant)
Sham in the fellow eye on Day 1.
200 µg Brimonidine Tartrate Implant Group B
200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
200 µg Brimonidine Tartrate Implant
200 µg brimonidine tartrate implant in the study eye on Day 1.
Sham (no implant)
Sham in the fellow eye on Day 1.
100 µg Brimonidine Tartrate Implant Group B
100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
100 µg Brimonidine Tartrate Implant
100 µg brimonidine tartrate implant in the study eye on Day 1.
Sham (no implant)
Sham in the fellow eye on Day 1.
100 µg Brimonidine Tartrate Implant Group A
100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
100 µg Brimonidine Tartrate Implant
100 µg brimonidine tartrate implant in the study eye on Day 1.
Sham (no implant)
Sham in the fellow eye on Day 1.
Interventions
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400 µg Brimonidine Tartrate Implant
400 µg brimonidine tartrate implant in the study eye on Day 1.
200 µg Brimonidine Tartrate Implant
200 µg brimonidine tartrate implant in the study eye on Day 1.
100 µg Brimonidine Tartrate Implant
100 µg brimonidine tartrate implant in the study eye on Day 1.
Sham (no implant)
Sham in the fellow eye on Day 1.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Visual acuity between 20/40 to count fingers
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Allergan
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Allergan
Locations
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Arlington, Texas, United States
Paris, , France
Tübingen, , Germany
Coimbra, , Portugal
Countries
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Other Identifiers
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190342-028D
Identifier Type: -
Identifier Source: org_study_id
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