Glaucoma, Open-Angle
Conditions
Brief summary
A multicenter, randomized, patient-masked, sham-controlled evaluation of the safety and effects on visual function of brimonidine intravitreal implant in patients with glaucomatous optic neuropathy. Patients will be followed for up to 1 year.
Interventions
400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
Sham Posterior Segment Drug Delivery system; Applicator System at Day 1 in 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
* Primary open-angle glaucoma in one eye * Visual acuity 20/80 or better * Intraocular pressure in the study eye ≤ 24 mm Hg * Glaucomatous visual field loss - 7 dB to - 25 dB
Exclusion criteria
* Known allergy to brimonidine tartrate * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With a Visual Field Improvement in the Study Eye | Baseline, Month 6 | Visual field improvement in the study eye is determined using the Humphrey Field Analyzer (HFA 24-2) full threshold test and clinical expertise. The Humphrey Field Analyzer is a machine that helps to map the field (peripheral) of vision. An improvement is an increase in the field of vision. The percentage of patients with a visual field improvement 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 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. |
Countries
Israel, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 400 ug Brimonidine Implant 400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye. | 25 |
| 200 ug Brimonidine Implant 200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye. | 21 |
| Sham (no Implant) Sham Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye. | 24 |
| Total | 70 |
Baseline characteristics
| Characteristic | 400 ug Brimonidine Implant | 200 ug Brimonidine Implant | Sham (no Implant) | Total |
|---|---|---|---|---|
| Age, Customized <45 years | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Age, Customized >65 years | 16 Participants | 10 Participants | 11 Participants | 37 Participants |
| Age, Customized Between 45 and 65 years | 9 Participants | 11 Participants | 12 Participants | 32 Participants |
| Mean Deviation from Normal Visual Field Using the HFA 24-2 | -15.5 Decibels (db) FULL_RANGE 5.26 | -14.6 Decibels (db) FULL_RANGE 3.67 | -17.9 Decibels (db) FULL_RANGE 5.09 | -16.0 Decibels (db) |
| Sex: Female, Male Female | 12 Participants | 12 Participants | 10 Participants | 34 Participants |
| Sex: Female, Male Male | 13 Participants | 9 Participants | 14 Participants | 36 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 | 18 / 25 | 19 / 21 | 20 / 24 |
| serious Total, serious adverse events | 3 / 25 | 5 / 21 | 1 / 24 |
Outcome results
Primary
Percentage of Patients With a Visual Field Improvement in the Study Eye
Visual field improvement in the study eye is determined using the Humphrey Field Analyzer (HFA 24-2) full threshold test and clinical expertise. The Humphrey Field Analyzer is a machine that helps to map the field (peripheral) of vision. An improvement is an increase in the field of vision. The percentage of patients with a visual field improvement in the study eye is reported.
Time frame: Baseline, Month 6
Population: Safety Population: all patients who received 1 dose of study medication or sham treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 400 ug Brimonidine Implant | Percentage of Patients With a Visual Field Improvement in the Study Eye | 12.0 Percentage of Patients |
| 200 ug Brimonidine Implant | Percentage of Patients With a Visual Field Improvement in the Study Eye | 9.5 Percentage of Patients |
| Sham (no Implant) | Percentage of Patients With a Visual Field Improvement in the Study Eye | 4.2 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 6
Population: Safety Population: all patients who received 1 dose of study medication or sham treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 400 ug Brimonidine Implant | Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye | Baseline | 76.0 Number of Letters Read Correctly | Standard Deviation 7.82 |
| 400 ug Brimonidine Implant | Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye | Change from Baseline at Month 6 | 2.8 Number of Letters Read Correctly | Standard Deviation 3.68 |
| 200 ug Brimonidine Implant | Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye | Baseline | 80.6 Number of Letters Read Correctly | Standard Deviation 6.2 |
| 200 ug Brimonidine Implant | Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye | Change from Baseline at Month 6 | -2.2 Number of Letters Read Correctly | Standard Deviation 18.35 |
| Sham (no Implant) | Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye | Baseline | 77.3 Number of Letters Read Correctly | Standard Deviation 7.71 |
| Sham (no Implant) | Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye | Change from Baseline at Month 6 | 0.3 Number of Letters Read Correctly | Standard Deviation 5.18 |