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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 400 ug Brimonidine Implant | Experimental | 400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye. |
|
| 200 ug Brimonidine Implant | Experimental | 200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye. |
|
| Sham (no implant) | Sham Comparator | Sham Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 400 ug Brimonidine Implant | Drug | 400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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 |
|---|---|---|---|---|---|---|
| Artesia | California | United States | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | 400 ug Brimonidine Implant | 400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye. |
| FG001 | 200 ug Brimonidine Implant | 200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye. |
| FG002 | Sham (no Implant) | Sham Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 400 ug Brimonidine Implant | 400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye. |
| BG001 | 200 ug Brimonidine Implant | 200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | 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. | Safety Population: all patients who received 1 dose of study medication or sham treatment | Posted | Number | Percentage of Patients | Baseline, Month 6 |
|
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For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events were reported in the SAE section, 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 ug Brimonidine Implant | 400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arteriospasm coronary | Cardiac disorders | MedDRA version 10.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival haemorrhage | Eye disorders | MedDRA version 10.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head, | Allergan, Inc | 714-246-4500 | clinicaltrials@allergan.com |
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000068438 | Brimonidine Tartrate |
| C005703 | salicylhydroxamic acid |
| ID | Term |
|---|---|
| D011810 | Quinoxalines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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|
| 200 ug Brimonidine Implant | Drug | 200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye. |
|
|
| Sham (no implant) | Drug | Sham Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye. |
|
| Baseline, Month 6 |
| Tel Aviv |
| Israel |
| BG002 | Sham (no Implant) | Sham Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Mean Deviation from Normal Visual Field Using the HFA 24-2 | Mean deviation is the difference between the expected normal visual field compared to the patient's visual field. | Mean | Full Range | Decibels (db) |
|
| 200 ug Brimonidine Implant |
200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye. |
| OG002 | Sham (no Implant) | Sham Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye. |
|
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| 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. | Safety Population: all patients who received 1 dose of study medication or sham treatment | Posted | Mean | Standard Deviation | Number of Letters Read Correctly | Baseline, Month 6 |
|
|
|
| 3 |
| 25 |
| 18 |
| 25 |
| EG001 | 200 ug Brimonidine Implant | 200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye. | 5 | 21 | 19 | 21 |
| EG002 | Sham (no Implant) | Sham Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye. | 1 | 24 | 20 | 24 |
| Cataract | Eye disorders | MedDRA version 10.0 | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA version 10.0 | Systematic Assessment |
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| Concussion | Injury, poisoning and procedural complications | MedDRA version 10.0 | Systematic Assessment |
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| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA version 10.0 | Systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA version 10.0 | Systematic Assessment |
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| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 10.0 | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA version 10.0 | Non-systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA version 10.0 | Non-systematic Assessment |
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| Intraocular pressure increased | Investigations | MedDRA version 10.0 | Systematic Assessment |
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| Punctate keratitis | Eye disorders | MedDRA version 10.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA version 10.0 | Non-systematic Assessment |
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| Conjunctival Hyperaemia | Eye disorders | MedDRA version 10.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA version 10.0 | Systematic Assessment |
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| Eye Irritation | Eye disorders | MedDRA version 10.0 | Non-systematic Assessment |
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| Eye Pain | Eye disorders | MedDRA version 10.0 | Non-systematic Assessment |
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| Blepharitis | Eye disorders | MedDRA version 10.0 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA version 10.0 | Non-systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA version 10.0 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA version 10.0 | Non-systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA version 10.0 | Systematic Assessment |
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| Lacrimation Increased | Eye disorders | MedDRA version 10.0 | Non-systematic Assessment |
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| Conjunctivitis | Eye disorders | MedDRA version 10.0 | Systematic Assessment |
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| Foreign Body Sensation in Eyes | Eye disorders | MedDRA version 10.0 | Non-systematic Assessment |
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| Vitreous Detachment | Eye disorders | MedDRA version 10.0 | Systematic Assessment |
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| Cataract | Eye disorders | MedDRA version 10.0 | Systematic Assessment |
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| Retinal Pigmentation | Eye disorders | MedDRA version 10.0 | Systematic Assessment |
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| Upper Respiratory Tract Infection | Infections and infestations | MedDRA version 10.0 | Systematic Assessment |
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| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | MedDRA version 10.0 | Non-systematic Assessment |
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| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA version 10.0 | 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.
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