Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 400 ug Brimonidine Implant | Experimental | 400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye. |
|
| 200 ug Brimonidine Implant | Experimental | 200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye. |
|
| Sham (no implant) | Sham Comparator | Sham Posterior Segment Drug Delivery system on Day 1 in the study eye. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 400 ug Brimonidine Implant | Drug | 400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Month 3 |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 Months |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abilene | Texas | United States | ||||
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 400 ug Brimonidine Implant | 400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye. |
| FG001 | 200 ug Brimonidine Implant | 200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 200 ug Brimonidine Implant | Drug | 200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye. |
|
|
| Sham (no implant) | Other | Sham Posterior Segment Drug Delivery system on Day 1 in the study eye. |
|
| Baseline, Month 3 |
| New Delhi |
| India |
| Tel Aviv | Israel |
| Makati | Philippines |
| Seoul | South Korea |
| London | United Kingdom |
| FG002 | Sham (no Implant) | Sham Posterior Segment Drug Delivery system on Day 1 in the study eye. |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 400 ug Brimonidine Implant | 400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye. |
| BG001 | 200 ug Brimonidine Implant | 200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye. |
| BG002 | Sham (no Implant) | Sham Posterior Segment Drug Delivery system on Day 1 in the study eye. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 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. | Intent to Treat: all randomized patients | Posted | Number | Percentage of Patients | Month 3 |
|
|
| ||||||||||||||||||||||||||||||||
| 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. | Intent to Treat: all randomized patients | Posted | Mean | Standard Deviation | Number of Letters Read Correctly | Baseline, Month 3 |
| |||||||||||||||||||||||||||||||||
| 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. | Intent to Treat: all randomized patients | Posted | Number | Percentage of Patients | 12 Months |
|
|
Not provided
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 are reported in the SAE section, regardless of the eye.
Not provided
| 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 on Day 1 in the study eye. | 0 | 15 | 7 | 15 | ||
| EG001 | 200 ug Brimonidine Implant | 200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye. | 2 | 15 | 12 | 15 | ||
| EG002 | Sham (no Implant) | Sham Posterior Segment Drug Delivery system on Day 1 in the study eye. | 2 | 14 | 9 | 14 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Haemorrhoids | Gastrointestinal disorders | MedDRA version 14.0 | Systematic Assessment |
| |
| Prostate Cancer [y] | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 14.0 | Systematic Assessment |
| |
| Myocardial Infarction | Cardiac disorders | MedDRA version 14.0 | Systematic Assessment |
| |
| Strabismus Correction | Surgical and medical procedures | MedDRA version 14.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival Haemorrhage | Eye disorders | MedDRA version 14.0 | Systematic Assessment |
| |
| Conjunctival Hyperaemia | Eye disorders | MedDRA version 14.0 | Systematic Assessment |
| |
| Eye Pruritus | Eye disorders | MedDRA version 14.0 | Systematic Assessment |
| |
| Eye Pain | Eye disorders | MedDRA version 14.0 | Non-systematic Assessment |
| |
| Hypotony of Eye | Eye disorders | MedDRA version 14.0 | Systematic Assessment |
| |
| Intraocular Pressure Decreased | Investigations | MedDRA version 14.0 | Systematic Assessment |
| |
| Conjunctival Oedema | Eye disorders | MedDRA version 14.0 | Non-systematic Assessment |
| |
| Maculopathy | Eye disorders | MedDRA version 14.0 | Systematic Assessment |
| |
| Cataract Subscapular | Eye disorders | MedDRA version 14.0 | Systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA version 14.0 | Systematic Assessment |
| |
| Retinal Haemorrhage | Eye disorders | MedDRA version 14.0 | Systematic Assessment |
| |
| Vitreous Floaters | Eye disorders | MedDRA version 14.0 | Non-systematic Assessment |
| |
| Abdominal Pain Lower | Gastrointestinal disorders | MedDRA version 14.0 | Non-systematic Assessment |
| |
| Cataract Nuclear | Eye disorders | MedDRA version 14.0 | Systematic Assessment |
| |
| Eye Irritation | Eye disorders | MedDRA version 14.0 | Non-systematic Assessment |
| |
| Influenza Like Illness | General disorders | MedDRA version 14.0 | Non-systematic Assessment |
| |
| Keratoconjunctivitis Sicca | Eye disorders | MedDRA version 14.0 | Systematic Assessment |
| |
| Optic Atrophy | Eye disorders | MedDRA version 14.0 | Systematic Assessment |
| |
| Optic Disc Haemorrhage | Eye disorders | MedDRA version 14.0 | Systematic Assessment |
| |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA version 14.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA version 14.0 | Systematic Assessment |
| |
| Vitreous Haemorrhage | Eye disorders | MedDRA version 14.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA version 14.0 | Systematic Assessment |
| |
| Posterior Capsule Opacification | Eye disorders | MedDRA version 14.0 | Systematic Assessment |
| |
| Vision Blurred | Eye disorders | MedDRA version 14.0 | Non-systematic Assessment |
| |
| Anterior Chamber Inflammation | Eye disorders | MedDRA version 14.0 | Systematic Assessment |
| |
| Cholecystitis Infective | Infections and infestations | MedDRA version 14.0 | Systematic Assessment |
| |
| Corneal Erosion | Eye disorders | MedDRA version 14.0 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA version 14.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA version 14.0 | Non-systematic Assessment |
| |
| Eyelid Cyst | Eye disorders | MedDRA version 14.0 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA version 14.0 | Non-systematic Assessment |
| |
| Head Injury | Injury, poisoning and procedural complications | MedDRA version 14.0 | Non-systematic Assessment |
| |
| Hypertonic Bladder | Renal and urinary disorders | MedDRA version 14.0 | Systematic Assessment |
| |
| Iritis | Eye disorders | MedDRA version 14.0 | Systematic Assessment |
| |
| Pharyngitis Streptococcal | Infections and infestations | MedDRA version 14.0 | Systematic Assessment |
| |
| Prostate Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 14.0 | Systematic Assessment |
| |
| Renal Mass | Renal and urinary disorders | MedDRA version 14.0 | Systematic Assessment |
| |
| Retinal Degeneration | Eye disorders | MedDRA version 14.0 | Systematic Assessment |
| |
| Retinal Depigmentation | Eye disorders | MedDRA version 14.0 | Systematic Assessment |
| |
| Seasonal Allergy | Immune system disorders | MedDRA version 14.0 | Non-systematic Assessment |
| |
| Visual Impairment | Eye disorders | MedDRA version 14.0 | Non-systematic Assessment |
| |
| Vitreous Disorder | Eye disorders | MedDRA version 14.0 | Systematic Assessment |
| |
| Vitreous Opacities | Eye disorders | MedDRA version 14.0 | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA version 14.0 | Systematic Assessment |
| |
| Conjunctival Granuloma | Eye disorders | MedDRA version 14.0 | Systematic Assessment |
| |
| Dry Eye | Eye disorders | MedDRA version 14.0 | Non-systematic Assessment |
| |
| Episcleritis | Eye disorders | MedDRA version 14.0 | Systematic Assessment |
| |
| Eyelid Ptosis | Eye disorders | MedDRA version 14.0 | Systematic Assessment |
| |
| Herpes Zoster | Infections and infestations | MedDRA version 14.0 | Non-systematic Assessment |
| |
| Hordeolum | Infections and infestations | MedDRA version 14.0 | Non-systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA version 14.0 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA version 14.0 | Non-systematic Assessment |
| |
| Iridocyclitis | Eye disorders | MedDRA version 14.0 | Systematic Assessment |
| |
| Macular Oedema | Eye disorders | MedDRA version 14.0 | Systematic Assessment |
| |
| Myocardial Infarction | Cardiac disorders | MedDRA version 14.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA version 14.0 | Non-systematic Assessment |
| |
| Retinal Aneurysm | Eye disorders | MedDRA version 14.0 | Systematic Assessment |
| |
| Scleral Disorder | Eye disorders | MedDRA version 14.0 | Systematic Assessment |
| |
| Strabismus Correction | Surgical and medical procedures | MedDRA version 14.0 | Systematic Assessment |
| |
| Tooth Abscess | Infections and infestations | MedDRA version 14.0 | Systematic Assessment |
| |
| Tooth Infection | Infections and infestations | MedDRA version 14.0 | Systematic Assessment |
|
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 |
| C005703 | salicylhydroxamic acid |
| ID | Term |
|---|---|
| D011810 | Quinoxalines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Male |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|