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

Sponsor:	Allergan
Information provided by:	Allergan
ClinicalTrials.gov Identifier:	NCT00661479

Purpose

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.

Condition	Intervention	Phase
Retinitis Pigmentosa	Drug: Brimonidine Tartrate	Phase I Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment

Resource links provided by NLM:

Genetics Home Reference related topics: Lenz microphthalmia syndrome oculofaciocardiodental syndrome Peters plus syndrome retinitis pigmentosa X-linked juvenile retinoschisis Help Me Understand Genetics

Drug Information available for: Brimonidine Brimonidine tartrate

U.S. FDA Resources

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:

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 ]

Estimated Enrollment:	25
Study Start Date:	July 2008
Study Completion Date:	June 2010
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Group A: 100 µg Brimonidine implant in study eye and sham in fellow eye	Drug: Brimonidine Tartrate Group A: 100 µg Brimonidine Tartrate in study eye and sham in fellow eye using Posterior Segment Drug Delivery System (PS DDS) Applicator on Day 1
Experimental: 2 Group B: 100 µg Brimonidine implant in study eye and sham in fellow eye	Drug: Brimonidine Tartrate Group B: 100 µg Brimonidine Tartrate in study eye and sham in fellow eye Posterior Segment Drug Delivery System (PS DDS) Applicator on Day 1
Experimental: 3 Group B: 200 µg Brimonidine implant in study eye and sham in fellow eye	Drug: Brimonidine Tartrate Group B: 200 µg Brimonidine Tartrate in study eye and sham in fellow eye using Posterior Segment Drug Delivery System (PS DDS) Applicator on Day 1
Experimental: 4 Group B: 400 µg Brimonidine implant in study eye and sham in fellow eye	Drug: Brimonidine Tartrate Group B: 400 µg Brimonidine Tartrate in study eye and sham in fellow eye using Posterior Segment Drug Delivery System (PS DDS) Applicator on Day 1

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00661479

Locations

United States, Texas

Arlington, Texas, United States
France

Paris, France
Germany

Tubingen, Germany
Portugal

Coimbra, Portugal

Sponsors and Collaborators

Allergan

Investigators

Study Director:

Medical Director

Allergan

More Information

No publications provided

Responsible Party:	Therapeutic Area Head, Allergan, Inc.
ClinicalTrials.gov Identifier:	NCT00661479 History of Changes
Other Study ID Numbers:	190342-028D
Study First Received:	October 29, 2007
Last Updated:	February 2, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Retinitis
Retinitis Pigmentosa
Retinal Diseases
Eye Diseases
Eye Diseases, Hereditary
Retinal Dystrophies
Retinal Degeneration
Genetic Diseases, Inborn
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 12, 2012