Patients Who Participated in an Intravitreal Brimo PS DDS® Study
Conditions
Brief summary
This study will evaluate the biodegradation of the brimonidine tartrate posterior segment drug delivery system.
Interventions
DRUGBrimo PS DDS®
Patients who received Brimo PS DDS® intravitreal implant in a previous study.
OTHERSham
Patients who recieved sham in a previous study.
Sponsors
Allergan
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
\- None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With No Visible Implants in the Study Eye | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Vision Loss in the Study Eye | Baseline of Parent Study, Month 36 | 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. |
Countries
Australia, Czechia, France, Germany, India, Israel, Italy, Philippines, Portugal, South Korea, United Kingdom, United States
Participant flow
Pre-assignment details
Patients enrolled in this extension study from the following parent studies: 190342-027D, 190342-028D, 190342-030D, 190342-031D, 190342-032D, and 190342-036. No treatment was administered in this study, so the treatment groups reflect the treatments received in the parent studies.
Participants by arm
| Arm | Count |
|---|---|
| Brimo PS DDS® 400 μg (2 Implants) Patients who received Brimo PS DDS® 400 μg (2 implants) in a previous study. | 28 |
| Brimo PS DDS® 400 μg (1 Implant) Patients who received Brimo PS DDS® 400 μg (1 implant) in a previous study. | 53 |
| Brimo PS DDS® 200 μg (2 Implants) Patients who received Brimo PS DDS® 200 μg (2 implants) in a previous study. | 33 |
| Brimo PS DDS® 200 μg (1 Implant) Patients who received Brimo PS DDS® 200 μg (1 implant) in a previous study. | 42 |
| Brimo PS DDS® 100 μg (1 Implant) Patients who received Brimo PS DDS® 100 μg (1 implant) in a previous study. | 6 |
| Brimo PS DDS® 50 μg (1 Implant) Patients who received Brimo PS DDS® 50 μg (1 implant) in a previous study. | 2 |
| Sham Patients who received sham in a previous study. | 51 |
| Total | 215 |
Baseline characteristics
| Characteristic | Brimo PS DDS® 400 μg (2 Implants) | Brimo PS DDS® 400 μg (1 Implant) | Brimo PS DDS® 200 μg (2 Implants) | Brimo PS DDS® 200 μg (1 Implant) | Brimo PS DDS® 100 μg (1 Implant) | Brimo PS DDS® 50 μg (1 Implant) | Sham | Total |
|---|---|---|---|---|---|---|---|---|
| Age, Customized 18 to 64 years | 2 Participants | 23 Participants | 3 Participants | 20 Participants | 3 Participants | 0 Participants | 20 Participants | 71 Participants |
| Age, Customized ≥85 years | 7 Participants | 1 Participants | 6 Participants | 3 Participants | 0 Participants | 1 Participants | 5 Participants | 23 Participants |
| Age, Customized Between 65 and 84 years | 19 Participants | 29 Participants | 24 Participants | 19 Participants | 3 Participants | 1 Participants | 26 Participants | 121 Participants |
| Sex: Female, Male Female | 19 Participants | 24 Participants | 17 Participants | 20 Participants | 3 Participants | 2 Participants | 21 Participants | 106 Participants |
| Sex: Female, Male Male | 9 Participants | 29 Participants | 16 Participants | 22 Participants | 3 Participants | 0 Participants | 30 Participants | 109 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 13 / 28 | 30 / 53 | 17 / 33 | 25 / 42 | 4 / 6 | 2 / 2 | 26 / 51 |
| serious Total, serious adverse events | 8 / 28 | 11 / 53 | 7 / 33 | 7 / 42 | 2 / 6 | 0 / 2 | 16 / 51 |
Outcome results
Primary
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.
Time frame: Month 36
Population: Safety Population: all enrolled patients, who received a sham or active study treatment of intravitreal Brimonidine Tartrate PS DDS in the parent study
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Brimo PS DDS® 400 μg (2 Implants) | Number of Patients With No Visible Implants in the Study Eye | 14 Patients |
| Brimo PS DDS® 400 μg (1 Implant) | Number of Patients With No Visible Implants in the Study Eye | 37 Patients |
| Brimo PS DDS® 200 μg (2 Implants) | Number of Patients With No Visible Implants in the Study Eye | 26 Patients |
| Brimo PS DDS® 200 μg (1 Implant) | Number of Patients With No Visible Implants in the Study Eye | 35 Patients |
| Brimo PS DDS® 100 μg (1 Implant) | Number of Patients With No Visible Implants in the Study Eye | 6 Patients |
| Brimo PS DDS® 50 μg (1 Implant) | Number of Patients With No Visible Implants in the Study Eye | 2 Patients |
| Sham | Number of Patients With No Visible Implants in the Study Eye | 46 Patients |
Secondary
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.
Time frame: Baseline of Parent Study, Month 36
Population: Safety Population: all enrolled patients, who received a sham or active study treatment of intravitreal Brimonidine Tartrate PS DDS in the parent study
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Brimo PS DDS® 400 μg (2 Implants) | Number of Patients With Vision Loss in the Study Eye | No or Mild Vision Loss | 14 Patients |
| Brimo PS DDS® 400 μg (2 Implants) | Number of Patients With Vision Loss in the Study Eye | Moderate Vision Loss | 6 Patients |
| Brimo PS DDS® 400 μg (2 Implants) | Number of Patients With Vision Loss in the Study Eye | Severe Vision Loss | 3 Patients |
| Brimo PS DDS® 400 μg (1 Implant) | Number of Patients With Vision Loss in the Study Eye | Moderate Vision Loss | 0 Patients |
| Brimo PS DDS® 400 μg (1 Implant) | Number of Patients With Vision Loss in the Study Eye | Severe Vision Loss | 1 Patients |
| Brimo PS DDS® 400 μg (1 Implant) | Number of Patients With Vision Loss in the Study Eye | No or Mild Vision Loss | 41 Patients |
| Brimo PS DDS® 200 μg (2 Implants) | Number of Patients With Vision Loss in the Study Eye | No or Mild Vision Loss | 23 Patients |
| Brimo PS DDS® 200 μg (2 Implants) | Number of Patients With Vision Loss in the Study Eye | Severe Vision Loss | 1 Patients |
| Brimo PS DDS® 200 μg (2 Implants) | Number of Patients With Vision Loss in the Study Eye | Moderate Vision Loss | 6 Patients |
| Brimo PS DDS® 200 μg (1 Implant) | Number of Patients With Vision Loss in the Study Eye | Moderate Vision Loss | 1 Patients |
| Brimo PS DDS® 200 μg (1 Implant) | Number of Patients With Vision Loss in the Study Eye | Severe Vision Loss | 0 Patients |
| Brimo PS DDS® 200 μg (1 Implant) | Number of Patients With Vision Loss in the Study Eye | No or Mild Vision Loss | 36 Patients |
| Brimo PS DDS® 100 μg (1 Implant) | Number of Patients With Vision Loss in the Study Eye | Moderate Vision Loss | 0 Patients |
| Brimo PS DDS® 100 μg (1 Implant) | Number of Patients With Vision Loss in the Study Eye | Severe Vision Loss | 0 Patients |
| Brimo PS DDS® 100 μg (1 Implant) | Number of Patients With Vision Loss in the Study Eye | No or Mild Vision Loss | 6 Patients |
| Brimo PS DDS® 50 μg (1 Implant) | Number of Patients With Vision Loss in the Study Eye | Severe Vision Loss | 0 Patients |
| Brimo PS DDS® 50 μg (1 Implant) | Number of Patients With Vision Loss in the Study Eye | No or Mild Vision Loss | 2 Patients |
| Brimo PS DDS® 50 μg (1 Implant) | Number of Patients With Vision Loss in the Study Eye | Moderate Vision Loss | 0 Patients |
| Sham | Number of Patients With Vision Loss in the Study Eye | No or Mild Vision Loss | 36 Patients |
| Sham | Number of Patients With Vision Loss in the Study Eye | Moderate Vision Loss | 6 Patients |
| Sham | Number of Patients With Vision Loss in the Study Eye | Severe Vision Loss | 4 Patients |