An Exploratory Study to Evaluate the Safety of Brimonidine Intravitreal Implant in Patients With Retinitis Pigmentosa - Tabular View

Tracking Information

First Received Date ^ICMJE

October 29, 2007

Last Updated Date

August 27, 2009

Start Date ^ICMJE

July 2008

Estimated Primary Completion Date

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

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Safety including adverse events, visual acuity, eye exam, visual fields, photography, and electroretinogram.

Change History

Complete list of historical versions of study NCT00661479 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Contrast sensitivity [ Time Frame: Day 1 - Month 12 ] [ Designated as safety issue: No ]
Patient questionnaires [ Time Frame: Day 1 - Month 12 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Contrast sensitivity, and patient questionaires

Descriptive Information

Brief Title ^ICMJE

An Exploratory Study to Evaluate the Safety of Brimonidine Intravitreal Implant in Patients With Retinitis Pigmentosa

Official Title ^ICMJE

Brief Summary

This exploratory, 12-month, ascending-dose study will evaluate the safety and effects on visual function of a single injection of Brimonidine intravitreal implant in one eye of patients with Retinitis Pigmentosa.

Detailed Description

Study Phase

Phase I, Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Single Blind (Subject), Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Retinitis Pigmentosa

Intervention ^ICMJE

Drug: Brimonidine Tartrate

Study Arms / Comparison Groups

Experimental: Group A: 100 µg Brimonidine implant in study eye and sham in fellow eye
Experimental: Group B: 100 µg Brimonidine implant in study eye and sham in fellow eye
Experimental: Group B: 200 µg Brimonidine implant in study eye and sham in fellow eye
Experimental: Group B: 400 µg Brimonidine implant in study eye and sham in fellow eye

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

July 2010

Estimated Primary Completion Date

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

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Retinitis Pigmentosa in both eyes
Visual acuity between 20/40 to count fingers

Exclusion Criteria:

Growth of new blood vessels in the eye
Any intraocular surgery or laser in either eye in the last 6 months prior to Screening visit or between the Screening visit and Day 1
Any ocular disease that can interfere with diagnosis and or assessment of disease progression
Significant near-sightedness
HIV
Female patients who are pregnant, nursing, or planning pregnancy

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, France, Germany, Portugal

Administrative Information

NCT ID ^ICMJE

NCT00661479

Responsible Party

Therapeutic Area Head, Allergan, Inc.

Study ID Numbers ^ICMJE

190342-028D

Study Sponsor ^ICMJE

Allergan

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Medical Director

Allergan

Information Provided By

Allergan

Verification Date

August 2009

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