Safety and Efficacy of Brimonidine Intravitreal Implant in Patients With Geographic Atrophy Due to Age-Related Macular Degeneration (AMD) - Full Text View

Sponsor:	Allergan
Information provided by:	Allergan
ClinicalTrials.gov Identifier:	NCT00658619

Purpose

Stage 1 is a patient-masked, dose-escalation, safety evaluation of brimonidine intravitreal implant. Patients will receive implant in one eye and "sham" treatment (meaning no treatment) in the fellow eye. Stage 2 will begin after 1 month of safety has been evaluated for Stage 1. Stage 2 is a randomized, double-masked, dose-response, sham-controlled evaluation of the safety and efficacy of brimonidine intravitreal implant in patients with geographic atrophy from age-related macular degeneration. Patients will be followed for up to 2 years.

Condition	Intervention	Phase
Macular Degeneration	Drug: Brimonidine Tartrate Implant Drug: Sham	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title:	Safety and Efficacy of Brimonidine Intravitreal Implant in Patients With Geographic Atrophy Due to AMD

Resource links provided by NLM:

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Macular Degeneration

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 size of geographic atrophy based on the stereoscopic color fundus photography and fluorescein angiography. [ Time Frame: Month 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Visual acuity [ Time Frame: Day 1 - Month 24 ] [ Designated as safety issue: No ]
Contrast sensitivity [ Time Frame: Day 1 - Month 24 ] [ Designated as safety issue: No ]
Reading speed [ Time Frame: Day 1 - Month 24 ] [ Designated as safety issue: No ]
Patient questionnaires [ Time Frame: Day 1 - Month 24 ] [ Designated as safety issue: No ]

Estimated Enrollment:	95
Study Start Date:	May 2008
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 Stage 1: 200 µg Brimonidine Implant in one eye and sham in fellow eye	Drug: Brimonidine Tartrate Implant Stage 1: 200 µg Brimonidine Tartrate Posterior Segment Drug Delivery system Applicator System at day 1 and month 6 in one eye and sham in fellow eye
2 Stage 1: 400 µg Brimonidine Implant in one eye and sham in fellow eye	Drug: Brimonidine Tartrate Implant Stage 1: 400 µg Brimonidine Tartrate Posterior Segment Drug Delivery system Applicator System at day 1 and month 6 in one eye and sham in fellow eye
3 Stage 2: 200 µg Brimonidine Implant in one eye and sham in fellow eye	Drug: Brimonidine Tartrate Implant Stage 2: 200 µg Brimonidine Tartrate Posterior Segment Drug Delivery system Applicator System at day 1 and month 6 in one eye and sham in fellow eye
4 Stage 2: 400 µg Brimonidine Implant in one eye and sham in fellow eye	Drug: Brimonidine Tartrate Implant Stage 2: 400 µg Brimonidine Tartrate Posterior Segment Drug Delivery system Applicator System at day 1 and month 6 in one eye and sham in fellow eye
5: Sham Comparator Stage 2: sham in both eyes	Drug: Sham Sham Posterior Segment Drug Delivery system Applicator System at day 1 and month 6 in both eyes

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Geographic atrophy in both eyes due to age-related macular degeneration
Visual acuity between 20/40 to 20/320

Exclusion Criteria:

Known allergy to brimonidine
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: NCT00658619

Locations

United States, Texas

Abilene, Texas, United States
Australia, New South Wales

Sydney, New South Wales, Australia
Germany

Karlsruhe, Germany
Italy

Udine, Italy
Korea, Republic of

Korea, Korea, Republic of
Philippines

Makati City, Philippines
Portugal

Coimbra, Portugal

Sponsors and Collaborators

Allergan

Investigators

Study Director:

Medical Director

Allergan

More Information

No publications provided

Responsible Party:	Allergan, Inc. ( Therapeutic Area Head )
Study ID Numbers:	190342-032D
Study First Received:	April 11, 2008
Last Updated:	April 16, 2009
ClinicalTrials.gov Identifier:	NCT00658619 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Pathological Conditions, Anatomical
Neurotransmitter Agents
Adrenergic alpha-Agonists
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Eye Diseases
Physiological Effects of Drugs
Macular Degeneration
Retinal Degeneration

Cardiovascular Agents
Antihypertensive Agents
Adrenergic Agonists
Pharmacologic Actions
Therapeutic Uses
Atrophy
Retinal Diseases
Brimonidine

ClinicalTrials.gov processed this record on November 09, 2009