NCT00693485

Brief Summary

A multicenter, randomized, patient-masked, sham-controlled evaluation of the safety and effects on visual function of brimonidine intravitreal implant in patients with glaucomatous optic neuropathy. Patients will be followed for up to 1 year.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2008

Typical duration for phase_2

Geographic Reach
2 countries

2 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

June 5, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 9, 2008

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2008

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
1.7 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

2.3 years

First QC Date

June 5, 2008

Results QC Date

March 13, 2013

Last Update Submit

March 13, 2013

Conditions

Glaucoma, Open-Angle

Outcome Measures

Primary Outcomes (1)

  • Percentage of Patients With a Visual Field Improvement in the Study Eye

    Visual field improvement in the study eye is determined using the Humphrey Field Analyzer (HFA 24-2) full threshold test and clinical expertise. The Humphrey Field Analyzer is a machine that helps to map the field (peripheral) of vision. An improvement is an increase in the field of vision. The percentage of patients with a visual field improvement in the study eye is reported.

    Baseline, Month 6

Secondary Outcomes (1)

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

    Baseline, Month 6

Study Arms (3)

400 ug Brimonidine Implant

EXPERIMENTAL

400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.

Drug: 400 ug Brimonidine Implant

200 ug Brimonidine Implant

EXPERIMENTAL

200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.

Drug: 200 ug Brimonidine Implant

Sham (no implant)

SHAM COMPARATOR

Sham Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.

Drug: Sham (no implant)

Interventions

400 ug Brimonidine ImplantDRUG

400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in 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; Applicator System at Day 1 in study eye.

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

Sham Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.

Sham (no implant)

Eligibility Criteria

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

You may qualify if:

  • Primary open-angle glaucoma in one eye
  • Visual acuity 20/80 or better
  • Intraocular pressure in the study eye ≤ 24 mm Hg
  • Glaucomatous visual field loss - 7 dB to - 25 dB

You may not qualify if:

  • Known allergy to brimonidine tartrate
  • Uncontrolled systemic disease or infection of the eye
  • Recent eye surgery or injections in the eye
  • Female patients who are pregnant, nursing or planning a pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Artesia, California, United States

Location

Unknown Facility

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle

Interventions

Brimonidine Tartratesalicylhydroxamic acid

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye Diseases

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

June 5, 2008

First Posted

June 9, 2008

Study Start

September 1, 2008

Primary Completion

January 1, 2011

Study Completion

August 1, 2011

Last Updated

April 24, 2013

Results First Posted

April 24, 2013

Record last verified: 2013-03

Locations

US(1)IL(1)