Safety and Efficacy of Brimonidine Tartrate Posterior Segment Drug Delivery System in Improving Visual Function - Full Text View

Sponsor:	Allergan
Information provided by (Responsible Party):	Allergan
ClinicalTrials.gov Identifier:	NCT00972374

Purpose

This study will evaluate the efficacy and safety of the Brimo PS DDS® Applicator System (200 μg and 400 μg brimonidine tartrate) on visual function in patients with previous rhegmatogenous macula-off retinal detachment.

Condition	Intervention	Phase
Rhegmatogenous Macula-off Retinal Detachment	Drug: 200 μg Brimonidine Tartrate Posterior Segment Drug Delivery system Drug: 400 μg Brimonidine Tartrate Posterior Segment Drug Delivery system Drug: Sham Posterior Segment Drug Delivery system	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
Official Title:	Safety and Efficacy of Brimonidine Tartrate Posterior Segment Drug Delivery System in Improving Visual Function

Resource links provided by NLM:

Drug Information available for: Brimonidine Brimonidine tartrate

U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:

Best Corrected Visual Acuity (BCVA) [ Time Frame: Month 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Mean BCVA change from baseline [ Time Frame: Change from baseline at Month 3 ] [ Designated as safety issue: No ]

Enrollment:	44
Study Start Date:	November 2009
Study Completion Date:	July 2011
Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 200 μg brimonidine implant in study eye	Drug: 200 μg Brimonidine Tartrate Posterior Segment Drug Delivery system Applicator System at Day 1 in study eye
Experimental: 2 400 μg brimonidine implant in study eye	Drug: 400 μg Brimonidine Tartrate Posterior Segment Drug Delivery system Applicator System at Day 1 in study eye
Sham Comparator: 3 Sham in study eye (no implant)	Drug: 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:

The macula-off retinal detachment must have been caused by a rupture (rhegmatogenous in etiology)
The repair of the macula-off retinal detachment must have occurred at least 6 months before the Day 1 visit in the study eye
The repair must have been deemed an anatomic success and required no more than one macular re-attachment procedure
The visual acuity score must be between 20/50 and 20/320 in the study eye

Exclusion Criteria:

Any sight-threatening ocular condition in the study eye other than the ruptured retinal detachment
Anticipated need for ocular surgery during the 12-month study period
Any injectable, periocular, or intravitreal corticosteroid treatment to study eye within 6 months prior to screening (eg, triamcinolone acetonide)
Any injectable, periocular, or intravitreal anti-VEGF treatment to the study eye within 3 months prior to screening (eg, Avastin or Lucentis)
Any infectious condition in the study eye

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00972374

Locations

United States, Texas

Abilene, Texas, United States
India

New Delhi, India
Israel

Tel Aviv, Israel
Korea, Republic of

Seoul, Korea, Republic of
Philippines

Makati, Philippines
United Kingdom

London, United Kingdom

Sponsors and Collaborators

Allergan

Investigators

Study Director:

Medical Director

Allergan

More Information

No publications provided

Responsible Party:	Allergan
ClinicalTrials.gov Identifier:	NCT00972374 History of Changes
Other Study ID Numbers:	190342-031D
Study First Received:	September 3, 2009
Last Updated:	October 20, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Retinal Detachment
Retinal Diseases
Eye 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