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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 400 µg Brimonidine Tartrate Implant | Experimental | 400 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy). |
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| 200 µg Brimonidine Tartrate Implant | Experimental | 200 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 400 µg Brimonidine Tartrate Implant | Drug | 400 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy). |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 60 Days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 60 Days |
| Percentage of Patient Samples With Plasma Levels of Brimonidine Below the Limit of Quantitation (BLQ) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Salt Lake City | Utah | United States | ||||
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | 200 µg Brimonidine Tartrate Implant |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| 200 µg Brimonidine Tartrate Implant | Drug | 200 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy). |
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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. |
| 60 Days |
| Prague |
| Czechia |
200 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| BG001 | 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). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Full Range | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Per Protocol: all subjects with pharmacokinetic data available | Posted | Number | Nanogram/milliliter (ng/mL) | 60 Days |
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| 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. | Per Protocol: all subjects with pharmacokinetic data available | Posted | Number | Nanogram/milliliter (ng/mL) | 60 Days |
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| 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. | Per Protocol: all subjects with qualified pharmacokinetic samples | Posted | Number | Percentage of Patient Samples | 60 Days | Patient Samples | Participants |
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For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of the eye.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). | 1 | 12 | 11 | 12 | ||
| EG001 | 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). | 2 | 12 | 12 | 12 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Choroidal Detachment | Eye disorders | MedDRA version 13.1 | Systematic Assessment |
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| Atrial Fibrillation | Cardiac disorders | MedDRA version 13.1 | Systematic Assessment |
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| Vitreous Haemorrhage | Eye disorders | MedDRA version 13.1 | Systematic Assessment |
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| Retinal Detachment | Eye disorders | MedDRA version 13.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival Haemorrhage | Eye disorders | MedDRA version 13.1 | Systematic Assessment |
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| Conjunctival Hyperaemia | Eye disorders | MedDRA version 13.1 | Systematic Assessment |
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| Conjunctival Oedema | Eye disorders | MedDRA version 13.1 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA version 13.1 | Systematic Assessment |
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| Intraocular Pressure Increased | Investigations | MedDRA version 13.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA version 13.1 | Systematic Assessment |
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| Cataract | Eye disorders | MedDRA version 13.1 | Systematic Assessment |
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| Eye Pain | Eye disorders | MedDRA version 13.1 | Non-systematic Assessment |
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| Atrial Fibrillation | Cardiac disorders | MedDRA version 13.1 | Systematic Assessment |
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| Cataract Nuclear | Eye disorders | MedDRA version 13.1 | Systematic Assessment |
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| Choroidal Detachment | Eye disorders | MedDRA version 13.1 | Systematic Assessment |
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| Hypotony of Eye | Eye disorders | MedDRA version 13.1 | Systematic Assessment |
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| Phlebitis Superficial | Vascular disorders | MedDRA version 13.1 | Systematic Assessment |
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| Vitreous Haemorrhage | Eye disorders | MedDRA version 13.1 | Systematic Assessment |
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| Retinal Detachment | Eye disorders | MedDRA version 13.1 | Systematic Assessment |
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| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA version 13.1 | Systematic Assessment |
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| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA version 13.1 | Systematic Assessment |
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| Conjunctivitis | Eye disorders | MedDRA version 13.1 | Systematic Assessment |
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| Device Dislocation | General disorders | MedDRA version 13.1 | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA version 13.1 | Non-systematic Assessment |
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| Visual Acuity Reduced | Eye disorders | MedDRA version 13.1 | Non-systematic Assessment |
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| Chorioretinal Disorder | Eye disorders | MedDRA version 13.1 | Systematic Assessment |
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| Eyelid Oedema | Eye disorders | MedDRA version 13.1 | Non-systematic Assessment |
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| Intraocular Pressure Decreased | Investigations | MedDRA version 13.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA version 13.1 | Non-systematic Assessment |
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| Retinal Tear | Eye disorders | MedDRA version 13.1 | Systematic Assessment |
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| Retinopathy Proliferative | Eye disorders | MedDRA version 13.1 | Systematic Assessment |
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A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head, | Allergan, Inc | 714-246-4500 | clinicaltrials@allergan.com |
| ID | Term |
|---|---|
| D000068438 | Brimonidine Tartrate |
| ID | Term |
|---|---|
| D011810 | Quinoxalines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Patient Samples |
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