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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00661479
Recruitment Status : Completed
First Posted : April 18, 2008
Results First Posted : April 24, 2013
Last Update Posted : April 24, 2013
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Retinitis Pigmentosa Drug: 400 µg Brimonidine Tartrate Implant Drug: 200 µg Brimonidine Tartrate Implant Drug: 100 µg Brimonidine Tartrate Implant Other: Sham (no implant) Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Study Start Date : July 2008
Actual Primary Completion Date : December 2009
Actual Study Completion Date : May 2010

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Drug: 400 µg Brimonidine Tartrate Implant
400 µg brimonidine tartrate implant in the study eye on Day 1.
Other Name: Brimonidine Tartrate PS DDS®

Other: Sham (no implant)
Sham in the fellow eye on Day 1.
Experimental: 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.
 Drug: 200 µg Brimonidine Tartrate Implant
200 µg brimonidine tartrate implant in the study eye on Day 1.
Other Name: Brimonidine Tartrate PS DDS®

Other: Sham (no implant)
Sham in the fellow eye on Day 1.
Experimental: 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.
 Drug: 100 µg Brimonidine Tartrate Implant
100 µg brimonidine tartrate implant in the study eye on Day 1.
Other Name: Brimonidine Tartrate PS DDS®

Other: Sham (no implant)
Sham in the fellow eye on Day 1.
Experimental: 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.
 Drug: 100 µg Brimonidine Tartrate Implant
100 µg brimonidine tartrate implant in the study eye on Day 1.
Other Name: Brimonidine Tartrate PS DDS®

Other: Sham (no implant)
Sham in the fellow eye on Day 1.


Outcome Measures
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Primary Outcome Measures :
  1. Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye [ Time Frame: Baseline, Month 6 ]
    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.


Secondary Outcome Measures :
  1. Change From Baseline in Contrast Sensitivity in the Study Eye [ Time Frame: Baseline, Month 6 ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00661479


Locations
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United States, Texas
Arlington, Texas, United States
France
Paris, France
Germany
Tubingen, Germany
Portugal
Coimbra, Portugal
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Medical Director Allergan
More Information
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00661479    
Other Study ID Numbers: 190342-028D
First Posted: April 18, 2008    Key Record Dates
Results First Posted: April 24, 2013
Last Update Posted: April 24, 2013
Last Verified: March 2013
Additional relevant MeSH terms:
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Retinitis
Retinitis Pigmentosa
Retinal Diseases
Eye Diseases
Eye Diseases, Hereditary
Retinal Dystrophies
Retinal Degeneration
Genetic Diseases, Inborn
Brimonidine Tartrate
 Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs