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

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ClinicalTrials.gov Identifier: NCT01229410
Recruitment Status : Completed
First Posted : October 27, 2010
Results First Posted : August 5, 2013
Last Update Posted : August 5, 2013
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Vitrectomy Drug: 400 µg Brimonidine Tartrate Implant Drug: 200 µg Brimonidine Tartrate Implant Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Study Start Date : December 2010
Actual Primary Completion Date : May 2011
Actual Study Completion Date : October 2011

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Arms and Interventions
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Arm Intervention/treatment
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®


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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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
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United States, Utah
Salt Lake City, Utah, United States
Czech Republic
Prague, Czech Republic
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Medical Director Allergan
More Information
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01229410    
Other Study ID Numbers: 190342-036
First Posted: October 27, 2010    Key Record Dates
Results First Posted: August 5, 2013
Last Update Posted: August 5, 2013
Last Verified: July 2013
Additional relevant MeSH terms:
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Brimonidine Tartrate
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