Phase 1
Completed N=24
Pharmacokinetics of the Brimonidine Tartrate Posterior Segment Delivery System in Patients Undergoing Pars Plana Vitrectomy
Vitrectomy
Source: ClinicalTrials.gov NCT01229410 ↗
Enrolled (actual)
24
Serious AEs
12.5%
Results posted
Aug 2013
Primary outcomePrimary: Highest Vitreous Humor Level of Brimonidine in the Study Eye — 137.0; 34.9 Nanogram/milliliter (ng/mL)
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Highest Vitreous Humor Level of Brimonidine in the Study Eye |
137.0; 34.9 | — |
| SECONDARY Highest Aqueous Humor Level of Brimonidine in the Study Eye |
17.5; 12.5 | — |
| SECONDARY Percentage of Patient Samples With Plasma Levels of Brimonidine Below the Limit of Quantitation (BLQ) |
53.3; 72.6 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01229410). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.