Safety Extension Study to Evaluate the Biodegradation of the Brimonidine Tartrate Posterior Segment Drug Delivery System
This study is ongoing, but not recruiting participants.
Sponsor:
Allergan
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01080209
First received: February 26, 2010
Last updated: March 13, 2013
Last verified: March 2013
| Tracking Information | |||||
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| First Received Date ICMJE | February 26, 2010 | ||||
| Last Updated Date | March 13, 2013 | ||||
| Start Date ICMJE | February 2010 | ||||
| Estimated Primary Completion Date | February 2014 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Status of implant degradation [ Time Frame: Month 36 ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Status of implant degradation [ Time Frame: Months 6, 12, 18, 24, 30, 36 ] [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT01080209 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Safety Extension Study to Evaluate the Biodegradation of the Brimonidine Tartrate Posterior Segment Drug Delivery System | ||||
| Official Title ICMJE | Not Provided | ||||
| Brief Summary | This study will evaluate the biodegradation of the brimonidine tartrate posterior segment drug delivery system. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Endpoint Classification: Pharmacodynamics Study Intervention Model: Single Group Assignment Masking: Single Blind (Subject) |
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| Condition ICMJE | Patients Who Participated in an Intravitreal Brimo PS DDS® Study | ||||
| Intervention ICMJE | Drug: intravitreal brimonidine tartrate implant using Posterior Segment Drug Delivery System (PS DDS®) Applicator
intravitreal brimonidine tartrate implant from a previous Brimo PS DDS® Study |
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| Study Arm (s) | Experimental: Brimo PS DDS®
Patients who have received a Brimo PS DDS® implant in a previous study
Intervention: Drug: intravitreal brimonidine tartrate implant using Posterior Segment Drug Delivery System (PS DDS®) Applicator |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | 215 | ||||
| Estimated Completion Date | February 2014 | ||||
| Estimated Primary Completion Date | February 2014 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: - None |
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States, Australia, France, Germany, India, Israel, Italy, Korea, Republic of, Philippines, Portugal, United Kingdom | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01080209 | ||||
| Other Study ID Numbers ICMJE | 190342-033D | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Allergan | ||||
| Study Sponsor ICMJE | Allergan | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Allergan | ||||
| Verification Date | March 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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