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

NCT01229410 | Completed Phase 1 Results

• 1 other identifier: 190342-036
• Study Type: interventional
• Target: 24
• Locations: 2 countries
• Sites: 2

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.

Conditions

Vitrectomy

Outcome Measures

Primary Outcomes (1)

• Highest Vitreous Humor Level of Brimonidine in the Study Eye

  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.

  60 Days

Secondary Outcomes (2)

• Highest Aqueous Humor Level of Brimonidine in the Study Eye

  60 Days

• Percentage of Patient Samples With Plasma Levels of Brimonidine Below the Limit of Quantitation (BLQ)

  60 Days

Study Arms (2)

400 µg Brimonidine Tartrate Implant

EXPERIMENTAL

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

200 µg Brimonidine Tartrate Implant

EXPERIMENTAL

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

Interventions

400 µg Brimonidine Tartrate Implant DRUG

400 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).

Also known as: Brimonidine Tartrate PS DDS®

400 µg Brimonidine Tartrate Implant

200 µg Brimonidine Tartrate Implant DRUG

200 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).

Also known as: Brimonidine Tartrate PS DDS®

200 µg Brimonidine Tartrate Implant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Allergan: lead

Study Sites (2)

Unknown Facility

Salt Lake City, Utah, United States

Location

Unknown Facility

Prague, Czechia

Location

MeSH Terms

Interventions

Brimonidine Tartrate

Intervention Hierarchy (Ancestors)

Quinoxalines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Therapeutic Area Head,
• Organization: Allergan, Inc

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Medical Director

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2010
• First Posted: October 27, 2010
• Study Start: December 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: October 1, 2011
• Last Updated: August 5, 2013
• Results First Posted: August 5, 2013

Record last verified: 2013-07

Locations

CZ (1); US (1)