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

Primary Purpose

Rhegmatogenous Macula-off Retinal Detachment

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
400 ug Brimonidine Implant
200 ug Brimonidine Implant
Sham (no implant)
Sponsored by
Allergan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rhegmatogenous Macula-off Retinal Detachment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

400 ug Brimonidine Implant

200 ug Brimonidine Implant

Sham (no implant)

Arm Description

400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.

200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.

Sham Posterior Segment Drug Delivery system on Day 1 in the study eye.

Outcomes

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
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
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.

Full Information

First Posted
September 3, 2009
Last Updated
March 13, 2013
Sponsor
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT00972374
Brief Title
Safety and Efficacy of Brimonidine Tartrate Posterior Segment Drug Delivery System in Improving Visual Function
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhegmatogenous Macula-off Retinal Detachment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
400 ug Brimonidine Implant
Arm Type
Experimental
Arm Description
400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
Arm Title
200 ug Brimonidine Implant
Arm Type
Experimental
Arm Description
200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
Arm Title
Sham (no implant)
Arm Type
Sham Comparator
Arm Description
Sham Posterior Segment Drug Delivery system on Day 1 in the study eye.
Intervention Type
Drug
Intervention Name(s)
400 ug Brimonidine Implant
Other Intervention Name(s)
Brimonidine Tartrate PS DDS®
Intervention Description
400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
Intervention Type
Drug
Intervention Name(s)
200 ug Brimonidine Implant
Other Intervention Name(s)
Brimonidine Tartrate PS DDS®
Intervention Description
200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
Intervention Type
Other
Intervention Name(s)
Sham (no implant)
Intervention Description
Sham Posterior Segment Drug Delivery system on Day 1 in the study eye.
Primary Outcome Measure Information:
Title
Percentage of Patients With at Least a 15-Letter Increase From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
Description
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.
Time Frame
Month 3
Secondary Outcome Measure Information:
Title
Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
Description
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.
Time Frame
Baseline, Month 3
Other Pre-specified Outcome Measures:
Title
Percentage of Patients With Intraocular Pressure (IOP) < 10 mmHg in the Study Eye at Any Follow up Visit
Description
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.
Time Frame
12 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
Abilene
State/Province
Texas
Country
United States
City
New Delhi
Country
India
City
Tel Aviv
Country
Israel
City
Seoul
Country
Korea, Republic of
City
Makati
Country
Philippines
City
London
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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