Phase 2
Completed N=215
Safety Extension Study to Evaluate the Biodegradation of the Brimonidine Tartrate Posterior Segment Drug Delivery System
Patients Who Participated in an Intravitreal Brimo PS DDS® Study
Source: ClinicalTrials.gov NCT01080209 ↗
Enrolled (actual)
215
Serious AEs
23.7%
Results posted
Feb 2015
Primary outcomePrimary: Number of Patients With No Visible Implants in the Study Eye — 14; 37; 26; 35 Patients
Summary
This study will evaluate the biodegradation of the brimonidine tartrate posterior segment drug delivery system.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With No Visible Implants in the Study Eye |
14; 37; 26; 35; 6; 2 | — |
| SECONDARY Number of Patients With Vision Loss in the Study Eye |
3; 1; 1; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Received the most recent sham or active study treatment of intravitreal Brimo PS DDS® no later than 36 months prior to entry into this study and have either completed their previous study, or have exited early from their previous study for any reason
- Applicable studies: Previous Allergan intravitreal Brimo PS DDS® treatment studies
Exclusion Criteria
- None
Data sourced from ClinicalTrials.gov (NCT01080209). 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.