Rhegmatogenous Macula-off Retinal DetachmentPhase 2NCT00972374
Safety and Efficacy of Brimonidine Tartrate Posterior Segment Drug Delivery System in Improving Visual Function
A Phase 2 study testing 400 ug Brimonidine Implant and 200 ug Brimonidine Implant in people with Rhegmatogenous Macula-off Retinal Detachment, run by Allergan at 6 sites in 6 countries.
Trial summary
This study will evaluate the efficacy and safety of the Brimo PS DDS® Applicator System (200 μg and 400 μg brimonidine tartrate) on visual function in patients with previous rhegmatogenous macula-off retinal detachment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rhegmatogenous Macula-off Retinal Detachment
- What is being tested?
- 400 ug Brimonidine Implant and 200 ug Brimonidine Implant
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 6 sitesin 6 countries
- Study dates
- Nov 2009to Jul 2011
- 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
- The macula-off retinal detachment must have been caused by a rupture (rhegmatogenous in etiology)
- The repair of the macula-off retinal detachment must have occurred at least 6 months before the Day 1 visit in the study eye
- The repair must have been deemed an anatomic success and required no more than one macular re-attachment procedure
- The visual acuity score must be between 20/50 and 20/320 in the study eye
Who cannot join
- Any sight-threatening ocular condition in the study eye other than the ruptured retinal detachment
- Anticipated need for ocular surgery during the 12-month study period
- Any injectable, periocular, or intravitreal corticosteroid treatment to study eye within 6 months prior to screening (eg, triamcinolone acetonide)
- Any injectable, periocular, or intravitreal anti-VEGF treatment to the study eye within 3 months prior to screening (eg, Avastin or Lucentis)
- Any infectious condition in the study eye
Trial locations and contacts
6 sites in 6 countries.
6 sites in 6 countries
About this study
This study will evaluate the efficacy and safety of the Brimo PS DDS® Applicator System (200 μg and 400 μg brimonidine tartrate) on visual function in patients with previous rhegmatogenous macula-off retinal detachment.
- Being tested
- 400 ug Brimonidine Implant, 200 ug Brimonidine Implant, Sham (no implant)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
400 ug Brimonidine ImplantDrug
Also called Brimonidine Tartrate PS DDS®
400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
200 ug Brimonidine ImplantDrug
Also called Brimonidine Tartrate PS DDS®
200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
Sham (no implant)Other
Sham Posterior Segment Drug Delivery system on Day 1 in the study eye.
| Study group | Role | What they receive |
|---|---|---|
| 400 ug Brimonidine Implant | Experimental | 400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye. Receives: Drug: 400 ug Brimonidine Implant |
| 200 ug Brimonidine Implant | Experimental | 200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye. Receives: Drug: 200 ug Brimonidine Implant |
| Sham (no implant) | Sham comparator | Sham Posterior Segment Drug Delivery system on Day 1 in the study eye. Receives: Other: Sham (no implant) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients With at Least a 15-Letter Increase From Baseline in 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). An increase in the number of letters read correctly indicates that vision has improved. The percentage of patients with at least a 15-letter increase in BCVA in the study eye is reported.
Measured: Month 3
Secondary outcomes (1)
Change From Baseline in 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) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening.
Measured: Baseline, Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2009 (estimated)
- Study startNov 2009
- Primary completionOct 2010
- Study completionJul 2011
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 Rhegmatogenous Macula-off Retinal DetachmentStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 44 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
- NCT00972374
- Sponsor's protocol ID
- 190342-031D
- Status last verified
- Mar 2013
- First submitted
- 3 Sep 2009
- Last updated
- 24 Apr 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Brimonidine Tartrate Posterior Segment Drug Delivery System in Improving Visual Function
- ClinicalTrials.gov ID
- NCT00972374
- Acronym / sponsor ID
- 190342-031D
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 4 Sep 2009 (estimated)
- Results
- Posted 24 Apr 2013
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 efficacy and safety of the Brimo PS DDS® Applicator System (200 μg and 400 μg brimonidine tartrate) on visual function in patients with previous rhegmatogenous macula-off retinal detachment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 400 ug Brimonidine Implant | Experimental | Drug: 400 ug Brimonidine Implant400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye. |
| 200 ug Brimonidine Implant | Experimental | Drug: 200 ug Brimonidine Implant200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye. |
| Sham (no implant) | Sham comparator | Other: Sham (no implant)Sham Posterior Segment Drug Delivery system on Day 1 in the study eye. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The macula-off retinal detachment must have been caused by a rupture (rhegmatogenous in etiology)
- The repair of the macula-off retinal detachment must have occurred at least 6 months before the Day 1 visit in the study eye
- The repair must have been deemed an anatomic success and required no more than one macular re-attachment procedure
- The visual acuity score must be between 20/50 and 20/320 in the study eye
Key exclusion criteria (5 listed)
- Any sight-threatening ocular condition in the study eye other than the ruptured retinal detachment
- Anticipated need for ocular surgery during the 12-month study period
- Any injectable, periocular, or intravitreal corticosteroid treatment to study eye within 6 months prior to screening (eg, triamcinolone acetonide)
- Any injectable, periocular, or intravitreal anti-VEGF treatment to the study eye within 3 months prior to screening (eg, Avastin or Lucentis)
- Any infectious condition in the study eye
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 |
|---|---|---|
| 400 ug Brimonidine ImplantAlso: Brimonidine Tartrate PS DDS®400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye. | Drug | 400 ug Brimonidine Implant |
| 200 ug Brimonidine ImplantAlso: Brimonidine Tartrate PS DDS®200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye. | Drug | 200 ug Brimonidine Implant |
| Sham (no implant)Sham Posterior Segment Drug Delivery system on Day 1 in the study eye. | Other | Sham (no implant) |
Primary outcome
Percentage of Patients With at Least a 15-Letter Increase From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
Time frame: Month 3
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). An increase in the number of letters read correctly indicates that vision has improved. The percentage of patients with at least a 15-letter increase in BCVA in the study eye is reported.
1 secondary outcome
Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
Time frame: Baseline, Month 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
6 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 400 ug Brimonidine Implant and 200 ug Brimonidine Implant in people with Rhegmatogenous Macula-off Retinal Detachment, run by Allergan at 6 sites in 6 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 4 inclusion and 5 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 24 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, India, Israel, Philippines, South Korea and 1 more country. 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 24 Apr 2013). 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?
Percentage of Patients With at Least a 15-Letter Increase From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye (time frame: Month 3). 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 24 Apr 2013.