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Pharmacokinetics of the Brimonidine Tartrate Posterior Segment Delivery System in Patients Undergoing Pars Plana Vitrectomy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01229410
First Posted: October 27, 2010
Last Update Posted: August 5, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Allergan
  Purpose
This study will evaluate the pharmacokinetics of brimonidine following a single intravitreal administration of the 200 ug or 400 ug Brimonidine Tartrate Posterior Segment Drug Delivery System in patients 2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy.

Condition Intervention Phase
Vitrectomy Drug: 400 µg Brimonidine Tartrate Implant Drug: 200 µg Brimonidine Tartrate Implant Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Highest Vitreous Humor Level of Brimonidine in the Study Eye [ Time Frame: 60 Days ]
    The highest level of brimonidine measured in the vitreous humor of the study eye in any patient is reported for each treatment arm. The vitreous humor is the clear gel that fills the space between the lens and the retina of the eye.


Secondary Outcome Measures:
  • Highest Aqueous Humor Level of Brimonidine in the Study Eye [ Time Frame: 60 Days ]
    The highest level of brimonidine measured in the aqueous humor of the study eye in any patient is reported for each treatment arm. The aqueous humor is the clear fluid in the chamber of the eye between the cornea and the lens.

  • Percentage of Patient Samples With Plasma Levels of Brimonidine Below the Limit of Quantitation (BLQ) [ Time Frame: 60 Days ]
    Percentage of patient samples with plasma levels of brimonidine reported as BLQ (i.e., too low to be determined using standard methods). Plasma is the fluid portion of the blood.


Enrollment: 24
Study Start Date: December 2010
Study Completion Date: October 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 400 µg Brimonidine Tartrate Implant
400 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).
Drug: 400 µg Brimonidine Tartrate Implant
400 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).
Other Name: Brimonidine Tartrate PS DDS®
Experimental: 200 µg Brimonidine Tartrate Implant
200 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).
Drug: 200 µg Brimonidine Tartrate Implant
200 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).
Other Name: Brimonidine Tartrate PS DDS®

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Plan on having a pars plana vitrectomy for repair of a posterior segment condition (eg, epiretinal membrane, macular hole, vitreomacular traction)
  • Visual acuity in the non-study eye better than 20/200

Exclusion Criteria:

  • History of pars plana vitrectomy or retinal detachment surgery in the study eye
  • Surgery or laser treatment in the study eye within 3 months
  • Use of brimonidine, apraclonidine or other topical alpha-2-agonist in either eye within 2 weeks
  • Intraocular infection or inflammation
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01229410


Locations
United States, Utah
Salt Lake City, Utah, United States
Czech Republic
Prague, Czech Republic
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01229410     History of Changes
Other Study ID Numbers: 190342-036
First Submitted: October 20, 2010
First Posted: October 27, 2010
Results First Submitted: March 13, 2013
Results First Posted: August 5, 2013
Last Update Posted: August 5, 2013
Last Verified: July 2013

Additional relevant MeSH terms:
Brimonidine Tartrate
Temazepam
Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Hypnotics and Sedatives
Central Nervous System Depressants
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents