Safety and Effects of Brimonidine Intravitreal Implant in Patients With Glaucomatous Optic Neuropathy - Full Text View

Sponsored by:	Allergan
Information provided by:	Allergan
ClinicalTrials.gov Identifier:	NCT00693485

Purpose

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.

Condition	Intervention	Phase
Glaucoma Optic Neuropathy	Drug: Brimonidine Tartrate Drug: Sham Implant (no implant)	Phase II

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma

Drug Information available for: Brimonidine Brimonidine Tartrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Further study details as provided by Allergan:

Primary Outcome Measures:

Change in visual acuity [ Time Frame: Month 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in visual fields [ Time Frame: Day 1 - Month 12 ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	September 2008
Estimated Study Completion Date:	November 2011
Estimated Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 200 µg Brimonidine Implant in study eye	Drug: Brimonidine Tartrate 200 µg Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye
2: Experimental 400 µg Brimonidine Implant in study eye	Drug: Brimonidine Tartrate 400 µg Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye
3: Sham Comparator Sham in study eye (no implant)	Drug: Sham Implant (no implant) Sham Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye (meaning no treatment)

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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 - 10 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00693485

Contacts

Contact: Allergan Inc

clinicaltrials@allergan.com

Locations

United States, California
	Recruiting
Artesia, California, United States

Sponsors and Collaborators

Allergan

Investigators

Study Director:

Medical Director

Allergan

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	Allergan, Inc. ( Therapeutic Area Head )
Study ID Numbers:	190342-030D
Study First Received:	June 5, 2008
Last Updated:	January 14, 2009
ClinicalTrials.gov Identifier:	NCT00693485
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Glaucoma
Eye Diseases
Optic Nerve Diseases
Optic nerve disorder

Brimonidine
Hypertension
Ocular Hypertension

Additional relevant MeSH terms:

Neurotransmitter Agents
Adrenergic alpha-Agonists
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Therapeutic Uses
Physiological Effects of Drugs

Nervous System Diseases
Cardiovascular Agents
Cranial Nerve Diseases
Antihypertensive Agents
Pharmacologic Actions
Adrenergic Agonists

ClinicalTrials.gov processed this record on January 16, 2009