Patients Who Participated in an Intravitreal Brimo PS DDS® StudyPhase 2NCT01080209
Safety Extension Study to Evaluate the Biodegradation of the Brimonidine Tartrate Posterior Segment Drug Delivery System
A Phase 2 study testing Brimo PS DDS® in people with Patients Who Participated in an Intravitreal Brimo PS DDS® Study, run by Allergan at 13 sites in 12 countries.
Trial summary
This study will evaluate the biodegradation of the brimonidine tartrate posterior segment drug delivery system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients Who Participated in an Intravitreal Brimo PS DDS® Study
- What is being tested?
- Brimo PS DDS®
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 215 participants
- Where
- 13 sitesin 12 countries
- Study dates
- Feb 2010to Feb 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
13 sites in 12 countries.
13 sites in 12 countries
Australia2 sites
Study site
Sydney, New South Wales
Study site
Westmead, New South Wales
About this study
This study will evaluate the biodegradation of the brimonidine tartrate posterior segment drug delivery system.
- Being tested
- Brimo PS DDS®, Sham
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brimo PS DDS®Drug
Patients who received Brimo PS DDS® intravitreal implant in a previous study.
ShamOther
Patients who recieved sham in a previous study.
| Study group | Role | What they receive |
|---|---|---|
| Brimo PS DDS® 400 μg (2 implants) | Experimental | Patients who received Brimo PS DDS® 400 μg (2 implants) in a previous study. Receives: Drug: Brimo PS DDS® |
| Brimo PS DDS® 400 μg (1 implant) | Experimental | Patients who received Brimo PS DDS® 400 μg (1 implant) in a previous study. Receives: Drug: Brimo PS DDS® |
| Brimo PS DDS® 200 μg (2 implants) | Experimental | Patients who received Brimo PS DDS® 200 μg (2 implants) in a previous study. Receives: Drug: Brimo PS DDS® |
| Brimo PS DDS® 200 μg (1 implant) | Experimental | Patients who received Brimo PS DDS® 200 μg (1 implant) in a previous study. Receives: Drug: Brimo PS DDS® |
| Brimo PS DDS® 100 μg (1 implant) | Experimental | Patients who received Brimo PS DDS® 100 μg (1 implant) in a previous study. Receives: Drug: Brimo PS DDS® |
| Brimo PS DDS® 50 μg (1 implant) | Experimental | Patients who received Brimo PS DDS® 50 μg (1 implant) in a previous study. Receives: Drug: Brimo PS DDS® |
| Sham | Sham comparator | Patients who received sham in a previous study. Receives: Other: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With No Visible Implants in the Study Eye
Implants administered during the parent study are evaluated during this study to determine if they have completely degraded. The time frame is evaluated from the point of the first treatment in the parent study.
Measured: Month 36
Secondary outcomes (1)
Number of Patients With Vision Loss in the Study Eye
Vision loss is assessed by Best Corrected Visual Acuity (BCVA) in the study eye. BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). Severe vision loss is a ≥30 letter decrease in BCVA. Moderate vision loss is a ≥15 and <30 letter decrease in BCVA. No or mild vision loss is <15 letter decrease in BCVA. Baseline of the parent study is defined as the point of the first study treatment.
Measured: Baseline of Parent Study, Month 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2010 (estimated)
- Study startFeb 2010
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Patients Who Participated in an Intravitreal Brimo PS DDS® StudyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 215 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01080209
- Sponsor's protocol ID
- 190342-033D
- Status last verified
- Feb 2015
- First submitted
- 26 Feb 2010
- Last updated
- 20 Feb 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Extension Study to Evaluate the Biodegradation of the Brimonidine Tartrate Posterior Segment Drug Delivery System
- ClinicalTrials.gov ID
- NCT01080209
- Acronym / sponsor ID
- 190342-033D
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 215 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 4 Mar 2010 (estimated)
- Results
- Posted 20 Feb 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the biodegradation of the brimonidine tartrate posterior segment drug delivery system.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Brimo PS DDS® 400 μg (2 implants) | Experimental | Drug: Brimo PS DDS®Patients who received Brimo PS DDS® 400 μg (2 implants) in a previous study. |
| Brimo PS DDS® 400 μg (1 implant) | Experimental | Drug: Brimo PS DDS®Patients who received Brimo PS DDS® 400 μg (1 implant) in a previous study. |
| Brimo PS DDS® 200 μg (2 implants) | Experimental | Drug: Brimo PS DDS®Patients who received Brimo PS DDS® 200 μg (2 implants) in a previous study. |
| Brimo PS DDS® 200 μg (1 implant) | Experimental | Drug: Brimo PS DDS®Patients who received Brimo PS DDS® 200 μg (1 implant) in a previous study. |
| Brimo PS DDS® 100 μg (1 implant) | Experimental | Drug: Brimo PS DDS®Patients who received Brimo PS DDS® 100 μg (1 implant) in a previous study. |
| Brimo PS DDS® 50 μg (1 implant) | Experimental | Drug: Brimo PS DDS®Patients who received Brimo PS DDS® 50 μg (1 implant) in a previous study. |
| Sham | Sham comparator | Other: ShamPatients who received sham in a previous study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brimo PS DDS®Patients who received Brimo PS DDS® intravitreal implant in a previous study. | Drug | Brimo PS DDS® 100 μg (1 implant), Brimo PS DDS® 200 μg (1 implant), Brimo PS DDS® 200 μg (2 implants), Brimo PS DDS® 400 μg (1 implant), Brimo PS DDS® 400 μg (2 implants), Brimo PS DDS® 50 μg (1 implant) |
| ShamPatients who recieved sham in a previous study. | Other | Sham |
Primary outcome
Number of Patients With No Visible Implants in the Study Eye
Time frame: Month 36
Implants administered during the parent study are evaluated during this study to determine if they have completely degraded. The time frame is evaluated from the point of the first treatment in the parent study.
1 secondary outcome
Number of Patients With Vision Loss in the Study Eye
Time frame: Baseline of Parent Study, Month 36
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Allergan
13 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Brimo PS DDS® in people with Patients Who Participated in an Intravitreal Brimo PS DDS® Study, run by Allergan at 13 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Australia, United States, Czechia, France, Germany and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients With No Visible Implants in the Study Eye (time frame: Month 36). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2015.