Macular DegenerationPhase 2NCT00658619
Safety and Efficacy of Brimonidine Intravitreal Implant in Patients With Geographic Atrophy Due to Age-related Macular Degeneration (AMD)
A Phase 2 study testing 400 µg Brimonidine Tartrate Implant and 200 µg Brimonidine Tartrate Implant in people with Macular Degeneration, run by Allergan at 7 sites in 7 countries.
Trial summary
Stage 1 is a patient-masked, dose-escalation, safety evaluation of brimonidine intravitreal implant. Patients will receive implant in one eye and "sham" treatment (meaning no treatment) in the fellow eye. Stage 2 will begin after 1 month of safety has been evaluated for Stage 1. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Macular Degeneration
- What is being tested?
- 400 µg Brimonidine Tartrate Implant and 200 µg Brimonidine Tartrate Implant
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 119 participants
- Where
- 7 sitesin 7 countries
- Study dates
- 1 May 2008to 8 Apr 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Geographic atrophy in both eyes due to age-related macular degeneration
- Visual acuity between 20/40 to 20/320
Who cannot join
- Known allergy to brimonidine
- Uncontrolled systemic disease or infection of the eye
- Recent eye surgery or injections in the eye
- Female patients who are pregnant, nursing or planning a pregnancy
Trial locations and contacts
7 sites in 7 countries.
7 sites in 7 countries
About this study
Official title: Safety and Efficacy of Brimonidine Intravitreal Implant in Patients With Geographic Atrophy Due to AMD
Stage 1 is a patient-masked, dose-escalation, safety evaluation of brimonidine intravitreal implant. Patients will receive implant in one eye and "sham" treatment (meaning no treatment) in the fellow eye. Stage 2 will begin after 1 month of safety has been evaluated for Stage 1. Stage 2 is a randomized, double-masked, dose-response, sham-controlled evaluation of the safety and efficacy of brimonidine intravitreal implant in patients with geographic atrophy from age-related macular degeneration. Patients will be followed for up to 2 years.
- Conditions
- Macular Degeneration
- Being tested
- 400 µg Brimonidine Tartrate Implant, 200 µg Brimonidine Tartrate Implant, Sham (no implant)
- Medical subject headings
- Macular Degeneration
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 and Month 6.
200 µg Brimonidine Tartrate ImplantDrug
Also called Brimonidine Tartrate PS DDS®
200 µg brimonidine tartrate implant in the study eye on Day 1 and Month 6.
Sham (no implant)Other
Sham in one or both eyes on Day 1 and Month 6.
| Study group | Role | What they receive |
|---|---|---|
| 400 µg Brimonidine Tartrate Implant Stage 1 | Other | Stage 1: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6. Receives: Drug: 400 µg Brimonidine Tartrate Implant; Other: Sham (no implant) |
| 200 µg Brimonidine Tartrate Implant Stage 1 | Other | Stage 1: 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6. Receives: Drug: 200 µg Brimonidine Tartrate Implant; Other: Sham (no implant) |
| 400 µg Brimonidine Tartrate Implant Stage 2 | Other | Stage 2: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6. Receives: Drug: 400 µg Brimonidine Tartrate Implant; Other: Sham (no implant) |
| 200 µg Brimonidine Tartrate Implant Stage 2 | Other | Stage 2: 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6. Receives: Drug: 200 µg Brimonidine Tartrate Implant; Other: Sham (no implant) |
| Sham (no implant) Stage 2 | Sham comparator | Stage 2: sham in both eyes on Day 1 and Month 6. Receives: 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 Size of Geographic Atrophy Lesion Area in the Study Eye
Change from baseline in size of geographic atrophy lesion area in the study eye is based on fundus photography as read by an independent Reading Center. Photographs are taken with a specialized microscope with an attached camera to photograph the interior of the eye, including the retina and optic disc. A positive change from baseline indicates an increase in size of geographic atrophy lesion area (worsening; disease progression). Data are reported in disc area where 1 disc area = 1.767 millimeters squared (mm^2).
Measured: Baseline, Month 12
Secondary outcomes (4)
Change From Baseline in Size of Geographic Atrophy Lesion Area in the Study Eye
Change from baseline in size of geographic atrophy lesion area in the study eye is based on fundus photography as read by an independent Reading Center. Photographs are taken with a specialized microscope with an attached camera to photograph the interior of the eye, including the retina and optic disc. A positive change from baseline indicates an increase in size of geographic atrophy lesion area (worsening; disease progression). Data are reported in disc area where 1 disc area = 1.767 millimeters squared (mm^2).
Measured: Baseline, Month 3, Month 6, Month 9, Month 18, Month 24
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, 24 Months
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, 24 Months
Change From Baseline in Reading Speed in the Study Eye
Change from baseline in reading speed in the study eye is assessed using modified Bailey-Lovie word charts. Patients read the chart for 2 minutes and the numbers of words read correctly per minute are totaled. An increase in the number of words read correctly indicates an improvement and a decrease in the number of words read correctly indicates a worsening.
Measured: Baseline, 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2008 (estimated)
- Study start1 May 2008
- Primary completion1 Jun 2010
- Study completion8 Apr 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Macular DegenerationStudies 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
- 119 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
- NCT00658619
- Sponsor's protocol ID
- 190342-032D
- Status last verified
- Jul 2018
- First submitted
- 11 Apr 2008
- Last updated
- 21 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Kuppermann BD, Patel SS, Boyer DS, Augustin AJ, Freeman WR, Kerr KJ, Guo Q, Schneider S, Lopez FJ; Brimo DDS Gen 1 Study Group. PHASE 2 STUDY OF THE SAFETY AND EFFICACY OF BRIMONIDINE DRUG DELIVERY SYSTEM (BRIMO DDS) GENERATION 1 IN PATIENTS WITH GEOGRAPHIC ATROPHY SECONDARY TO AGE-RELATED MACULAR DEGENERATION. Retina. 2021 Jan 1;41(1):144-155. doi: 10.1097/IAE.0000000000002789.
PubMed 32134802
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Brimonidine Intravitreal Implant in Patients With Geographic Atrophy Due to AMD
- ClinicalTrials.gov ID
- NCT00658619
- Acronym / sponsor ID
- 190342-032D
- Conditions
- Macular Degeneration
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 1 May 2008 (actual)
- Primary completion
- 1 Jun 2010 (actual)
- Study completion
- 8 Apr 2011 (actual)
- First posted
- 15 Apr 2008 (estimated)
- Results
- Posted 26 Apr 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Stage 1 is a patient-masked, dose-escalation, safety evaluation of brimonidine intravitreal implant. Patients will receive implant in one eye and "sham" treatment (meaning no treatment) in the fellow eye. Stage 2 will begin after 1 month of safety has been evaluated for Stage 1. Stage 2 is a randomized, double-masked, dose-response, sham-controlled evaluation of the safety and efficacy of brimonidine intravitreal implant in patients with geographic atrophy from age-related macular degeneration. Patients will be followed for up to 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 400 µg Brimonidine Tartrate Implant Stage 1 | Other | Drug: 400 µg Brimonidine Tartrate Implant, Other: Sham (no implant)Stage 1: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6. |
| 200 µg Brimonidine Tartrate Implant Stage 1 | Other | Drug: 200 µg Brimonidine Tartrate Implant, Other: Sham (no implant)Stage 1: 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6. |
| 400 µg Brimonidine Tartrate Implant Stage 2 | Other | Drug: 400 µg Brimonidine Tartrate Implant, Other: Sham (no implant)Stage 2: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6. |
| 200 µg Brimonidine Tartrate Implant Stage 2 | Other | Drug: 200 µg Brimonidine Tartrate Implant, Other: Sham (no implant)Stage 2: 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6. |
| Sham (no implant) Stage 2 | Sham comparator | Other: Sham (no implant)Stage 2: sham in both eyes on Day 1 and Month 6. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Geographic atrophy in both eyes due to age-related macular degeneration
- Visual acuity between 20/40 to 20/320
Key exclusion criteria (4 listed)
- Known allergy to brimonidine
- Uncontrolled systemic disease or infection of the eye
- Recent eye surgery or injections in the eye
- Female patients who are pregnant, nursing or planning a pregnancy
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 and Month 6. | Drug | 400 µg Brimonidine Tartrate Implant Stage 1, 400 µg Brimonidine Tartrate Implant Stage 2 |
| 200 µg Brimonidine Tartrate ImplantAlso: Brimonidine Tartrate PS DDS®200 µg brimonidine tartrate implant in the study eye on Day 1 and Month 6. | Drug | 200 µg Brimonidine Tartrate Implant Stage 1, 200 µg Brimonidine Tartrate Implant Stage 2 |
| Sham (no implant)Sham in one or both eyes on Day 1 and Month 6. | Other | 200 µg Brimonidine Tartrate Implant Stage 1, 200 µg Brimonidine Tartrate Implant Stage 2, 400 µg Brimonidine Tartrate Implant Stage 1, 400 µg Brimonidine Tartrate Implant Stage 2, Sham (no implant) Stage 2 |
Primary outcome
Change From Baseline in Size of Geographic Atrophy Lesion Area in the Study Eye
Time frame: Baseline, Month 12
Change from baseline in size of geographic atrophy lesion area in the study eye is based on fundus photography as read by an independent Reading Center. Photographs are taken with a specialized microscope with an attached camera to photograph the interior of the eye, including the retina and optic disc. A positive change from baseline indicates an increase in size of geographic atrophy lesion area (worsening; disease progression). Data are reported in disc area where 1 disc area = 1.767 millimeters squared (mm^2).
4 secondary outcomes
Change From Baseline in Size of Geographic Atrophy Lesion Area in the Study Eye
Time frame: Baseline, Month 3, Month 6, Month 9, Month 18, Month 24
Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
Time frame: Baseline, 24 Months
Change From Baseline in Contrast Sensitivity in the Study Eye
Time frame: Baseline, 24 Months
Change From Baseline in Reading Speed in the Study Eye
Time frame: Baseline, 24 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32134802Kuppermann BD, Patel SS, Boyer DS, Augustin AJ, Freeman WR, Kerr KJ, Guo Q, Schneider S, Lopez FJ; Brimo DDS Gen 1 Study Group. PHASE 2 STUDY OF THE SAFETY AND EFFICACY OF BRIMONIDINE DRUG DELIVERY SYSTEM (BRIMO DDS) GENERATION 1 IN PATIENTS WITH GEOGRAPHIC ATROPHY SECONDARY TO AGE-RELATED MACULAR DEGENERATION. Retina. 2021 Jan 1;41(1):144-155. doi: 10.1097/IAE.0000000000002789.
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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
7 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 400 µg Brimonidine Tartrate Implant and 200 µg Brimonidine Tartrate Implant in people with Macular Degeneration, run by Allergan at 7 sites in 7 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 4 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 21 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Australia, Germany, Italy, Philippines and 2 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 26 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 Size of Geographic Atrophy Lesion Area in the Study Eye (time frame: Baseline, Month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00658619, which also lists 1 linked publication.
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 21 Aug 2018.