Vitrectomy
Conditions
Brief summary
This study will evaluate the pharmacokinetics of brimonidine following a single intravitreal administration of the 200 ug or 400 ug Brimonidine Tartrate Posterior Segment Drug Delivery System in patients 2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy.
Interventions
400 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).
200 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Plan on having a pars plana vitrectomy for repair of a posterior segment condition (eg, epiretinal membrane, macular hole, vitreomacular traction) * Visual acuity in the non-study eye better than 20/200
Exclusion criteria
* History of pars plana vitrectomy or retinal detachment surgery in the study eye * Surgery or laser treatment in the study eye within 3 months * Use of brimonidine, apraclonidine or other topical alpha-2-agonist in either eye within 2 weeks * Intraocular infection or inflammation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Highest Vitreous Humor Level of Brimonidine in the Study Eye | 60 Days | The highest level of brimonidine measured in the vitreous humor of the study eye in any patient is reported for each treatment arm. The vitreous humor is the clear gel that fills the space between the lens and the retina of the eye. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Highest Aqueous Humor Level of Brimonidine in the Study Eye | 60 Days | The highest level of brimonidine measured in the aqueous humor of the study eye in any patient is reported for each treatment arm. The aqueous humor is the clear fluid in the chamber of the eye between the cornea and the lens. |
| Percentage of Patient Samples With Plasma Levels of Brimonidine Below the Limit of Quantitation (BLQ) | 60 Days | Percentage of patient samples with plasma levels of brimonidine reported as BLQ (i.e., too low to be determined using standard methods). Plasma is the fluid portion of the blood. |
Countries
Czechia, United States
Participant flow
Pre-assignment details
Patients were enrolled in groups by planned time of pars plana vitrectomy (Week 2, 4, or 8 post-implant). Patients who had the implant removed during the vitrectomy did not complete the 6 month follow-up per protocol.
Participants by arm
| Arm | Count |
|---|---|
| 400 µg Brimonidine Tartrate Implant 400 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy). | 12 |
| 200 µg Brimonidine Tartrate Implant 200 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy). | 12 |
| Total | 24 |
Baseline characteristics
| Characteristic | 400 µg Brimonidine Tartrate Implant | 200 µg Brimonidine Tartrate Implant | Total |
|---|---|---|---|
| Age Continuous | 69.7 Years FULL_RANGE 2.87 | 66.5 Years FULL_RANGE 9.67 | 68.1 Years |
| Sex: Female, Male Female | 8 Participants | 6 Participants | 14 Participants |
| Sex: Female, Male Male | 4 Participants | 6 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 11 / 12 | 12 / 12 |
| serious Total, serious adverse events | 1 / 12 | 2 / 12 |
Outcome results
Primary
Highest Vitreous Humor Level of Brimonidine in the Study Eye
The highest level of brimonidine measured in the vitreous humor of the study eye in any patient is reported for each treatment arm. The vitreous humor is the clear gel that fills the space between the lens and the retina of the eye.
Time frame: 60 Days
Population: Per Protocol: all subjects with pharmacokinetic data available
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 400 µg Brimonidine Tartrate Implant | Highest Vitreous Humor Level of Brimonidine in the Study Eye | 137.0 Nanogram/milliliter (ng/mL) |
| 200 µg Brimonidine Tartrate Implant | Highest Vitreous Humor Level of Brimonidine in the Study Eye | 34.9 Nanogram/milliliter (ng/mL) |
Secondary
Highest Aqueous Humor Level of Brimonidine in the Study Eye
The highest level of brimonidine measured in the aqueous humor of the study eye in any patient is reported for each treatment arm. The aqueous humor is the clear fluid in the chamber of the eye between the cornea and the lens.
Time frame: 60 Days
Population: Per Protocol: all subjects with pharmacokinetic data available
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 400 µg Brimonidine Tartrate Implant | Highest Aqueous Humor Level of Brimonidine in the Study Eye | 17.5 Nanogram/milliliter (ng/mL) |
| 200 µg Brimonidine Tartrate Implant | Highest Aqueous Humor Level of Brimonidine in the Study Eye | 12.5 Nanogram/milliliter (ng/mL) |
Secondary
Percentage of Patient Samples With Plasma Levels of Brimonidine Below the Limit of Quantitation (BLQ)
Percentage of patient samples with plasma levels of brimonidine reported as BLQ (i.e., too low to be determined using standard methods). Plasma is the fluid portion of the blood.
Time frame: 60 Days
Population: Per Protocol: all subjects with qualified pharmacokinetic samples
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 400 µg Brimonidine Tartrate Implant | Percentage of Patient Samples With Plasma Levels of Brimonidine Below the Limit of Quantitation (BLQ) | 53.3 Percentage of Patient Samples |
| 200 µg Brimonidine Tartrate Implant | Percentage of Patient Samples With Plasma Levels of Brimonidine Below the Limit of Quantitation (BLQ) | 72.6 Percentage of Patient Samples |