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Safety and Efficacy of Brimonidine Tartrate Posterior Segment Drug Delivery System in Improving Visual Function

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: NCT00972374
Recruitment Status : Completed
First Posted : September 4, 2009
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 September 3, 2009
First Posted Date  ICMJE September 4, 2009
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 November 2009
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 13, 2013)
Percentage of Patients With at Least a 15-Letter Increase From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye [ Time Frame: Month 3 ]
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly indicates that vision has improved. The percentage of patients with at least a 15-letter increase in BCVA in the study eye is reported.
Original Primary Outcome Measures  ICMJE
 (submitted: September 3, 2009)
Best Corrected Visual Acuity (BCVA) [ Time Frame: Month 3 ]
Change History Complete list of historical versions of study NCT00972374 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 13, 2013)
Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye [ Time Frame: Baseline, Month 3 ]
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 Secondary Outcome Measures  ICMJE
 (submitted: September 3, 2009)
Mean BCVA change from baseline [ Time Frame: Change from baseline at Month 3 ]
Current Other Pre-specified Outcome Measures
 (submitted: March 13, 2013)
Percentage of Patients With Intraocular Pressure (IOP) < 10 mmHg in the Study Eye at Any Follow up Visit [ Time Frame: 12 Months ]
IOP is the fluid pressure inside the eye. The percentage of patients with IOP < 10 millimeters of mercury (mmHg) in the study eye at any follow up visit is presented.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Brimonidine Tartrate Posterior Segment Drug Delivery System in Improving Visual Function
Official Title  ICMJE Not Provided
Brief Summary This study will evaluate the efficacy and safety of the Brimo PS DDS® Applicator System (200 μg and 400 μg brimonidine tartrate) on visual function in patients with previous rhegmatogenous macula-off retinal detachment.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Rhegmatogenous Macula-off Retinal Detachment
Intervention  ICMJE
  • Drug: 400 ug Brimonidine Implant
    400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
    Other Name: Brimonidine Tartrate PS DDS®
  • Drug: 200 ug Brimonidine Implant
    200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
    Other Name: Brimonidine Tartrate PS DDS®
  • Other: Sham (no implant)
    Sham Posterior Segment Drug Delivery system on Day 1 in the study eye.
Study Arms  ICMJE
  • Experimental: 400 ug Brimonidine Implant
    400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
    Intervention: Drug: 400 ug Brimonidine Implant
  • Experimental: 200 ug Brimonidine Implant
    200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
    Intervention: Drug: 200 ug Brimonidine Implant
  • Sham Comparator: Sham (no implant)
    Sham Posterior Segment Drug Delivery system on Day 1 in the study eye.
    Intervention: 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: October 18, 2011)
44
Original Estimated Enrollment  ICMJE
 (submitted: September 3, 2009)
99
Actual Study Completion Date  ICMJE July 2011
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • The macula-off retinal detachment must have been caused by a rupture (rhegmatogenous in etiology)
  • The repair of the macula-off retinal detachment must have occurred at least 6 months before the Day 1 visit in the study eye
  • The repair must have been deemed an anatomic success and required no more than one macular re-attachment procedure
  • The visual acuity score must be between 20/50 and 20/320 in the study eye

Exclusion Criteria:

  • Any sight-threatening ocular condition in the study eye other than the ruptured retinal detachment
  • Anticipated need for ocular surgery during the 12-month study period
  • Any injectable, periocular, or intravitreal corticosteroid treatment to study eye within 6 months prior to screening (eg, triamcinolone acetonide)
  • Any injectable, periocular, or intravitreal anti-VEGF treatment to the study eye within 3 months prior to screening (eg, Avastin or Lucentis)
  • Any infectious condition in the study eye
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 India,   Israel,   Korea, Republic of,   Philippines,   United Kingdom,   United States
Removed Location Countries Australia,   Italy
 
Administrative Information
NCT Number  ICMJE NCT00972374
Other Study ID Numbers  ICMJE 190342-031D
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