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

Sponsor:	Allergan
Information provided by (Responsible Party):	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Outcomes Assessor) Primary Purpose: Treatment

Resource links provided by NLM:

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma

Drug Information available for: Brimonidine Brimonidine tartrate

U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:

Change from Baseline in Visual Fields [ Time Frame: Baseline, Month 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from Baseline in Visual Acuity [ Time Frame: Baseline, Month 6 ] [ Designated as safety issue: No ]

Enrollment:	70
Study Start Date:	September 2008
Study Completion Date:	August 2011
Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 200 µg Brimonidine Implant 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
Experimental: 400 µg Brimonidine Implant 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
Sham Comparator: Sham 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 and older
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 - 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

Contacts and Locations

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

Locations

United States, California

Artesia, California, United States
Israel

Tel Aviv, Israel

Sponsors and Collaborators

Allergan

Investigators

Study Director:

Medical Director

Allergan

More Information

No publications provided

Responsible Party:	Allergan
ClinicalTrials.gov Identifier:	NCT00693485 History of Changes
Other Study ID Numbers:	190342-030D
Study First Received:	June 5, 2008
Last Updated:	January 26, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Glaucoma
Optic Nerve Diseases
Ocular Hypertension
Eye Diseases
Cranial Nerve Diseases
Nervous System Diseases
Brimonidine
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists

Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012