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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT00661479
First received: October 29, 2007
Last updated: March 13, 2013
Last verified: March 2013
  Purpose

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 Intervention 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 Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye [ Time Frame: Baseline, Month 6 ] [ Designated as safety issue: No ]
    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:
  • Change From Baseline in Contrast Sensitivity in the Study Eye [ Time Frame: Baseline, Month 6 ] [ Designated as safety issue: No ]
    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.


Enrollment: 21
Study Start Date: July 2008
Study Completion Date: May 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00661479

Locations
United States, Texas
Arlington, Texas, United States
France
Paris, France
Germany
Tubingen, Germany
Portugal
Coimbra, Portugal
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00661479     History of Changes
Other Study ID Numbers: 190342-028D
Study First Received: October 29, 2007
Results First Received: March 13, 2013
Last Updated: March 13, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Retinitis
Retinitis Pigmentosa
Retinal Diseases
Eye Diseases
Eye Diseases, Hereditary
Retinal Dystrophies
Retinal Degeneration
Genetic Diseases, Inborn
Brimonidine
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014