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

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.

Study Overview

• Status: Completed
• Conditions: Rhegmatogenous Macula-off Retinal Detachment
• Intervention / Treatment: Drug: 400 ug Brimonidine Implant; Drug: 200 ug Brimonidine Implant; Other: Sham (no implant)

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Phase 2

Contacts and Locations

Study Locations

• India
  • New Delhi, India
• Israel
  • Tel Aviv, Israel
• Korea, Republic of
  • Seoul, Korea, Republic of
• Philippines
  • Makati, Philippines
• United Kingdom
  • London, United Kingdom
• United States
  • Texas
    • Abilene, Texas, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Patients With at Least a 15-Letter Increase From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye	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.	Month 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye	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.	Baseline, Month 3

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Patients With Intraocular Pressure (IOP) < 10 mmHg in the Study Eye at Any Follow up Visit	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.	12 Months

Collaborators and Investigators

• Sponsor: Allergan

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Actual): October 1, 2010
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: September 3, 2009
• First Submitted That Met QC Criteria: September 3, 2009
• First Posted (Estimate): September 4, 2009

Study Record Updates

• Last Update Posted (Estimate): April 24, 2013
• Last Update Submitted That Met QC Criteria: March 13, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Retinal Detachment; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Brimonidine Tartrate
• Other Study ID Numbers: 190342-031D