Safety and Effects of Brimonidine Intravitreal Implant in Patients With Glaucomatous Optic Neuropathy

NCT ID: NCT00693485

Last Updated: 2013-04-24

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2011-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Glaucoma, Open-Angle

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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400 ug Brimonidine Implant

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

Group Type EXPERIMENTAL

400 ug Brimonidine Implant

Intervention Type DRUG

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

200 ug Brimonidine Implant

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

Group Type EXPERIMENTAL

200 ug Brimonidine Implant

Intervention Type DRUG

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

Sham (no implant)

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

Group Type SHAM_COMPARATOR

Sham (no implant)

Intervention Type DRUG

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

Interventions

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400 ug Brimonidine Implant

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

Intervention Type DRUG

200 ug Brimonidine Implant

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

Intervention Type DRUG

Sham (no implant)

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

Intervention Type DRUG

Other Intervention Names

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Brimonidine Tartrate PS DDS® Brimonidine Tartrate PS DDS®

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Allergan

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Allergan

Locations

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Artesia, California, United States

Site Status

Tel Aviv, , Israel

Site Status

Countries

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United States Israel

Other Identifiers

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190342-030D

Identifier Type: -

Identifier Source: org_study_id

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