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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT00972374
First received: September 3, 2009
Last updated: March 13, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention Phase
Rhegmatogenous Macula-off Retinal Detachment
Drug: 400 ug Brimonidine Implant
Drug: 200 ug Brimonidine Implant
Other: Sham (no implant)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • 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 ] [ 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). 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.


Secondary Outcome Measures:
  • Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye [ Time Frame: Baseline, Month 3 ] [ 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.


Other Outcome Measures:
  • Percentage of Patients With Intraocular Pressure (IOP) < 10 mmHg in the Study Eye at Any Follow up Visit [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    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.


Enrollment: 44
Study Start Date: November 2009
Study Completion Date: July 2011
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 400 ug Brimonidine Implant
400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
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®
Experimental: 200 ug Brimonidine Implant
200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
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®
Sham Comparator: Sham (no implant)
Sham Posterior Segment Drug Delivery system on Day 1 in the study eye.
Other: Sham (no implant)
Sham Posterior Segment Drug Delivery system on Day 1 in the study eye.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00972374

Locations
United States, Texas
Abilene, Texas, United States
India
New Delhi, India
Israel
Tel Aviv, Israel
Korea, Republic of
Seoul, Korea, Republic of
Philippines
Makati, Philippines
United Kingdom
London, United Kingdom
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00972374     History of Changes
Other Study ID Numbers: 190342-031D
Study First Received: September 3, 2009
Results First Received: March 13, 2013
Last Updated: March 13, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Retinal Detachment
Retinal Diseases
Eye Diseases
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 April 14, 2014