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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

Tracking Information
First Submitted Date  ICMJE October 29, 2007
First Posted Date  ICMJE April 18, 2008
Results First Submitted Date  ICMJE March 13, 2013
Results First Posted Date  ICMJE April 24, 2013
Last Update Posted Date April 24, 2013
Study Start Date  ICMJE July 2008
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 13, 2013)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 16, 2008)
Safety including adverse events, visual acuity, eye exam, visual fields, photography, and electroretinogram.
Change History Complete list of historical versions of study NCT00661479 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 13, 2013)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 16, 2008)
Contrast sensitivity, and patient questionaires
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Exploratory Study to Evaluate the Safety of Brimonidine Intravitreal Implant in Patients With Retinitis Pigmentosa
Official Title  ICMJE Not Provided
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Retinitis Pigmentosa
Intervention  ICMJE
  • Drug: 400 µg Brimonidine Tartrate Implant
    400 µg brimonidine tartrate implant in the study eye on Day 1.
    Other Name: Brimonidine Tartrate PS DDS®
  • Drug: 200 µg Brimonidine Tartrate Implant
    200 µg brimonidine tartrate implant in the study eye on Day 1.
    Other Name: Brimonidine Tartrate PS DDS®
  • 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.
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: 400 µg Brimonidine Tartrate Implant
    • Other: Sham (no implant)
  • 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.
    Interventions:
    • Drug: 200 µg Brimonidine Tartrate Implant
    • Other: Sham (no implant)
  • 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.
    Interventions:
    • Drug: 100 µg Brimonidine Tartrate Implant
    • Other: Sham (no implant)
  • 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.
    Interventions:
    • Drug: 100 µg Brimonidine Tartrate Implant
    • Other: Sham (no implant)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 13, 2013)
21
Original Estimated Enrollment  ICMJE
 (submitted: April 16, 2008)
22
Actual Study Completion Date  ICMJE May 2010
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   Germany,   Portugal,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00661479
Other Study ID Numbers  ICMJE 190342-028D
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Allergan
Study Sponsor  ICMJE Allergan
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Allergan
PRS Account Allergan
Verification Date March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP