Retinitis PigmentosaPhase 1/2NCT00661479
An Exploratory Study to Evaluate the Safety of Brimonidine Intravitreal Implant in Patients With Retinitis Pigmentosa
A Phase 1/2 study testing 400 µg Brimonidine Tartrate Implant, 200 µg Brimonidine Tartrate Implant and 100 µg Brimonidine Tartrate Implant in people with Retinitis Pigmentosa, run by Allergan at 4 sites in 4 countries.
Trial summary
This exploratory, 12-month, ascending-dose study will evaluate the safety and effects on visual function of a single injection of Brimonidine intravitreal implant in one eye of patients with Retinitis Pigmentosa. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retinitis Pigmentosa
- What is being tested?
- 400 µg Brimonidine Tartrate Implant, 200 µg Brimonidine Tartrate Implant and 100 µg Brimonidine Tartrate Implant
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Jul 2008to May 2010
- Phase
- Phase 1/2
- 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
- Retinitis Pigmentosa in both eyes
- Visual acuity between 20/40 to count fingers
Who cannot join
- Growth of new blood vessels in the eye
- Any intraocular surgery or laser in either eye in the last 6 months prior to Screening visit or between the Screening visit and Day 1
- Any ocular disease that can interfere with diagnosis and or assessment of disease progression
- Significant near-sightedness
- HIV
- Female patients who are pregnant, nursing, or planning pregnancy
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
About this study
This exploratory, 12-month, ascending-dose study will evaluate the safety and effects on visual function of a single injection of Brimonidine intravitreal implant in one eye of patients with Retinitis Pigmentosa.
- Conditions
- Retinitis Pigmentosa
- Being tested
- 400 µg Brimonidine Tartrate Implant, 200 µg Brimonidine Tartrate Implant, 100 µg Brimonidine Tartrate Implant, Sham (no implant)
- Medical subject headings
- Retinitis Pigmentosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
400 µg Brimonidine Tartrate ImplantDrug
Also called Brimonidine Tartrate PS DDS®
400 µg brimonidine tartrate implant in the study eye on Day 1.
200 µg Brimonidine Tartrate ImplantDrug
Also called Brimonidine Tartrate PS DDS®
200 µg brimonidine tartrate implant in the study eye on Day 1.
100 µg Brimonidine Tartrate ImplantDrug
Also called Brimonidine Tartrate PS DDS®
100 µg brimonidine tartrate implant in the study eye on Day 1.
Sham (no implant)Other
Sham in the fellow eye on Day 1.
| Study group | Role | What they receive |
|---|---|---|
| 400 µg Brimonidine Tartrate Implant Group B | Experimental | 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1. Receives: Drug: 400 µg Brimonidine Tartrate Implant; Other: Sham (no implant) |
| 200 µg Brimonidine Tartrate Implant Group B | Experimental | 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1. Receives: Drug: 200 µg Brimonidine Tartrate Implant; Other: Sham (no implant) |
| 100 µg Brimonidine Tartrate Implant Group B | Experimental | 100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1. Receives: Drug: 100 µg Brimonidine Tartrate Implant; Other: Sham (no implant) |
| 100 µg Brimonidine Tartrate Implant Group A | Experimental | 100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1. Receives: Drug: 100 µg Brimonidine Tartrate Implant; Other: Sham (no implant) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 6
Secondary outcomes (1)
Change From Baseline in Contrast Sensitivity in the Study Eye
Change from baseline in contrast sensitivity in the study eye is measured using a Pelli-Robson contrast sensitivity chart at 1 meter. The contrast sensitivity chart contains letters that are darkest at the top and then get progressively lighter. Scores range from 0 to 48 and are based on the number of letters read correctly. A negative change from baseline indicates a worsening in contrast sensitivity and a positive change from baseline indicates an improvement.
Measured: Baseline, Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2008 (estimated)
- Study startJul 2008
- Primary completionDec 2009
- Study completionMay 2010
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 Retinitis PigmentosaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 21 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
- NCT00661479
- Sponsor's protocol ID
- 190342-028D
- Status last verified
- Mar 2013
- First submitted
- 29 Oct 2007
- 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
- An Exploratory Study to Evaluate the Safety of Brimonidine Intravitreal Implant in Patients With Retinitis Pigmentosa
- ClinicalTrials.gov ID
- NCT00661479
- Acronym / sponsor ID
- 190342-028D
- Conditions
- Retinitis Pigmentosa
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 18 Apr 2008 (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 exploratory, 12-month, ascending-dose study will evaluate the safety and effects on visual function of a single injection of Brimonidine intravitreal implant in one eye of patients with Retinitis Pigmentosa.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 400 µg Brimonidine Tartrate Implant Group B | Experimental | Drug: 400 µg Brimonidine Tartrate Implant, Other: Sham (no implant)400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1. |
| 200 µg Brimonidine Tartrate Implant Group B | Experimental | Drug: 200 µg Brimonidine Tartrate Implant, Other: Sham (no implant)200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1. |
| 100 µg Brimonidine Tartrate Implant Group B | Experimental | Drug: 100 µg Brimonidine Tartrate Implant, Other: Sham (no implant)100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1. |
| 100 µg Brimonidine Tartrate Implant Group A | Experimental | Drug: 100 µg Brimonidine Tartrate Implant, Other: Sham (no implant)100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Retinitis Pigmentosa in both eyes
- Visual acuity between 20/40 to count fingers
Key exclusion criteria (6 listed)
- Growth of new blood vessels in the eye
- Any intraocular surgery or laser in either eye in the last 6 months prior to Screening visit or between the Screening visit and Day 1
- Any ocular disease that can interfere with diagnosis and or assessment of disease progression
- Significant near-sightedness
- HIV
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 µg Brimonidine Tartrate ImplantAlso: Brimonidine Tartrate PS DDS®400 µg brimonidine tartrate implant in the study eye on Day 1. | Drug | 400 µg Brimonidine Tartrate Implant Group B |
| 200 µg Brimonidine Tartrate ImplantAlso: Brimonidine Tartrate PS DDS®200 µg brimonidine tartrate implant in the study eye on Day 1. | Drug | 200 µg Brimonidine Tartrate Implant Group B |
| 100 µg Brimonidine Tartrate ImplantAlso: Brimonidine Tartrate PS DDS®100 µg brimonidine tartrate implant in the study eye on Day 1. | Drug | 100 µg Brimonidine Tartrate Implant Group A, 100 µg Brimonidine Tartrate Implant Group B |
| Sham (no implant)Sham in the fellow eye on Day 1. | Other | 100 µg Brimonidine Tartrate Implant Group A, 100 µg Brimonidine Tartrate Implant Group B, 200 µg Brimonidine Tartrate Implant Group B, 400 µg Brimonidine Tartrate Implant Group B |
Primary outcome
Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
Time frame: Baseline, Month 6
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.
1 secondary outcome
Change From Baseline in Contrast Sensitivity in the Study Eye
Time frame: Baseline, Month 6
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
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing 400 µg Brimonidine Tartrate Implant, 200 µg Brimonidine Tartrate Implant and 100 µg Brimonidine Tartrate Implant in people with Retinitis Pigmentosa, run by Allergan at 4 sites in 4 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 6 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 4 sites in United States, France, Germany, Portugal. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye (time frame: Baseline, Month 6). 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.