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

Tracking Information

First Received Date ^ICMJE

April 11, 2008

Last Updated Date

April 16, 2009

Start Date ^ICMJE

May 2008

Estimated Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00658619 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Safety and Efficacy of Brimonidine Intravitreal Implant in Patients With Geographic Atrophy Due to AMD

Brief Summary

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.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Macular Degeneration

Intervention ^ICMJE

Drug: Brimonidine Tartrate Implant
Drug: Sham

Study Arms / Comparison Groups

Other: Stage 1: 200 µg Brimonidine Implant in one eye and sham in fellow eye
Other: Stage 1: 400 µg Brimonidine Implant in one eye and sham in fellow eye
Other: Stage 2: 200 µg Brimonidine Implant in one eye and sham in fellow eye
Other: Stage 2: 400 µg Brimonidine Implant in one eye and sham in fellow eye
Sham Comparator: Stage 2: sham in both eyes

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2011

Estimated Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

50 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Australia, Germany, Italy, Korea, Republic of, Philippines, Portugal

Administrative Information

NCT ID ^ICMJE

NCT00658619

Responsible Party

Therapeutic Area Head, Allergan, Inc.

Study ID Numbers ^ICMJE

190342-032D

Study Sponsor ^ICMJE

Allergan

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Medical Director

Allergan

Information Provided By

Allergan

Verification Date

April 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP