NCT00972374

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2009

Geographic Reach
6 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 3, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 4, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

April 24, 2013

Completed
Last Updated

April 24, 2013

Status Verified

March 1, 2013

Enrollment Period

11 months

First QC Date

September 3, 2009

Results QC Date

March 13, 2013

Last Update Submit

March 13, 2013

Conditions

Rhegmatogenous Macula-off Retinal Detachment

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye

    Baseline, Month 3

Other Outcomes (1)

  • Percentage of Patients With Intraocular Pressure (IOP) < 10 mmHg in the Study Eye at Any Follow up Visit

    12 Months

Study Arms (3)

400 ug Brimonidine Implant

EXPERIMENTAL

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

Drug: 400 ug Brimonidine Implant

200 ug Brimonidine Implant

EXPERIMENTAL

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

Drug: 200 ug Brimonidine Implant

Sham (no implant)

SHAM COMPARATOR

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

Other: Sham (no implant)

Interventions

400 ug Brimonidine ImplantDRUG

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

Also known as: Brimonidine Tartrate PS DDS®
400 ug Brimonidine Implant
200 ug Brimonidine ImplantDRUG

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

Also known as: Brimonidine Tartrate PS DDS®
200 ug Brimonidine Implant
Sham (no implant)OTHER

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

Sham (no implant)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Unknown Facility

Abilene, Texas, United States

Location

Unknown Facility

New Delhi, India

Location

Unknown Facility

Tel Aviv, Israel

Location

Unknown Facility

Makati, Philippines

Location

Unknown Facility

Seoul, South Korea

Location

Unknown Facility

London, United Kingdom

Location

MeSH Terms

Interventions

Brimonidine Tartratesalicylhydroxamic acid

Intervention Hierarchy (Ancestors)

QuinoxalinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title
Therapeutic Area Head,
Organization
Allergan, Inc
clinicaltrials@allergan.com
714-246-4500

Study Officials

  • Medical Director

    Allergan

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2009

First Posted

September 4, 2009

Study Start

November 1, 2009

Primary Completion

October 1, 2010

Study Completion

July 1, 2011

Last Updated

April 24, 2013

Results First Posted

April 24, 2013

Record last verified: 2013-03

Locations

IL(1)PH(1)GB(1)US(1)IN(1)KR(1)