Rhegmatogenous Macula-off Retinal Detachment
Conditions
Brief 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.
Interventions
400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
OTHERSham (no implant)
Sham Posterior Segment Drug Delivery system on Day 1 in the study eye.
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With at Least a 15-Letter Increase From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye | Baseline, 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) 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With Intraocular Pressure (IOP) < 10 mmHg in the Study Eye at Any Follow up Visit | 12 Months | IOP is the fluid pressure inside the eye. The percentage of patients with IOP \< 10 millimeters of mercury (mmHg) in the study eye at any follow up visit is presented. |
Countries
India, Israel, Philippines, South Korea, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 400 ug Brimonidine Implant 400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye. | 15 |
| 200 ug Brimonidine Implant 200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye. | 15 |
| Sham (no Implant) Sham Posterior Segment Drug Delivery system on Day 1 in the study eye. | 14 |
| Total | 44 |
Baseline characteristics
| Characteristic | 400 ug Brimonidine Implant | 200 ug Brimonidine Implant | Sham (no Implant) | Total |
|---|---|---|---|---|
| Age Continuous | 54.2 Years STANDARD_DEVIATION 17.12 | 54.3 Years STANDARD_DEVIATION 20.36 | 56.1 Years STANDARD_DEVIATION 15.19 | 54.9 Years STANDARD_DEVIATION 17.35 |
| Sex: Female, Male Female | 6 Participants | 5 Participants | 5 Participants | 16 Participants |
| Sex: Female, Male Male | 9 Participants | 10 Participants | 9 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 7 / 15 | 12 / 15 | 9 / 14 |
| serious Total, serious adverse events | 0 / 15 | 2 / 15 | 2 / 14 |
Outcome results
Primary
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.
Time frame: Month 3
Population: Intent to Treat: all randomized patients
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 400 ug Brimonidine Implant | Percentage of Patients With at Least a 15-Letter Increase From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye | 6.7 Percentage of Patients |
| 200 ug Brimonidine Implant | Percentage of Patients With at Least a 15-Letter Increase From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye | 6.7 Percentage of Patients |
| Sham (no Implant) | Percentage of Patients With at Least a 15-Letter Increase From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye | 0 Percentage of Patients |
Secondary
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.
Time frame: Baseline, Month 3
Population: Intent to Treat: all randomized patients
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 400 ug Brimonidine Implant | Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye | Baseline | 46.6 Number of Letters Read Correctly | Standard Deviation 13.69 |
| 400 ug Brimonidine Implant | Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye | Change from Baseline at Month 3 | 6.0 Number of Letters Read Correctly | Standard Deviation 6.23 |
| 200 ug Brimonidine Implant | Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye | Baseline | 53.3 Number of Letters Read Correctly | Standard Deviation 8.46 |
| 200 ug Brimonidine Implant | Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye | Change from Baseline at Month 3 | 3.1 Number of Letters Read Correctly | Standard Deviation 6.78 |
| Sham (no Implant) | Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye | Baseline | 50.3 Number of Letters Read Correctly | Standard Deviation 10.92 |
| Sham (no Implant) | Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye | Change from Baseline at Month 3 | 4.8 Number of Letters Read Correctly | Standard Deviation 4.64 |
Other Pre-specified
Percentage of Patients With Intraocular Pressure (IOP) < 10 mmHg in the Study Eye at Any Follow up Visit
IOP is the fluid pressure inside the eye. The percentage of patients with IOP \< 10 millimeters of mercury (mmHg) in the study eye at any follow up visit is presented.
Time frame: 12 Months
Population: Intent to Treat: all randomized patients
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 400 ug Brimonidine Implant | Percentage of Patients With Intraocular Pressure (IOP) < 10 mmHg in the Study Eye at Any Follow up Visit | 20.0 Percentage of Patients |
| 200 ug Brimonidine Implant | Percentage of Patients With Intraocular Pressure (IOP) < 10 mmHg in the Study Eye at Any Follow up Visit | 26.7 Percentage of Patients |
| Sham (no Implant) | Percentage of Patients With Intraocular Pressure (IOP) < 10 mmHg in the Study Eye at Any Follow up Visit | 28.6 Percentage of Patients |