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
Stage 1 is a patient-masked, dose-escalation, safety evaluation of brimonidine intravitreal implant. Patients will receive implant in one eye and "sham" treatment (meaning no treatment) in the fellow eye. Stage 2 will begin after 1 month of safety has been evaluated for Stage 1. Stage 2 is a randomized, double-masked, dose-response, sham-controlled evaluation of the safety and efficacy of brimonidine intravitreal implant in patients with geographic atrophy from age-related macular degeneration. Patients will be followed for up to 2 years.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 400 µg Brimonidine Tartrate Implant Stage 1 | Other | Stage 1: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6. |
|
| 200 µg Brimonidine Tartrate Implant Stage 1 | Other | Stage 1: 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6. |
|
| 400 µg Brimonidine Tartrate Implant Stage 2 | Other | Stage 2: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6. |
|
| 200 µg Brimonidine Tartrate Implant Stage 2 | Other | Stage 2: 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6. |
|
| Sham (no implant) Stage 2 | Sham Comparator | Stage 2: sham in both eyes on Day 1 and Month 6. |
| 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 and Month 6. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Size of Geographic Atrophy Lesion Area in the Study Eye | Change from baseline in size of geographic atrophy lesion area in the study eye is based on fundus photography as read by an independent Reading Center. Photographs are taken with a specialized microscope with an attached camera to photograph the interior of the eye, including the retina and optic disc. A positive change from baseline indicates an increase in size of geographic atrophy lesion area (worsening; disease progression). Data are reported in disc area where 1 disc area = 1.767 millimeters squared (mm^2). | Baseline, Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Size of Geographic Atrophy Lesion Area in the Study Eye | Change from baseline in size of geographic atrophy lesion area in the study eye is based on fundus photography as read by an independent Reading Center. Photographs are taken with a specialized microscope with an attached camera to photograph the interior of the eye, including the retina and optic disc. A positive change from baseline indicates an increase in size of geographic atrophy lesion area (worsening; disease progression). Data are reported in disc area where 1 disc area = 1.767 millimeters squared (mm^2). |
Not provided
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 | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32134802 | Derived | Kuppermann BD, Patel SS, Boyer DS, Augustin AJ, Freeman WR, Kerr KJ, Guo Q, Schneider S, Lopez FJ; Brimo DDS Gen 1 Study Group. PHASE 2 STUDY OF THE SAFETY AND EFFICACY OF BRIMONIDINE DRUG DELIVERY SYSTEM (BRIMO DDS) GENERATION 1 IN PATIENTS WITH GEOGRAPHIC ATROPHY SECONDARY TO AGE-RELATED MACULAR DEGENERATION. Retina. 2021 Jan 1;41(1):144-155. doi: 10.1097/IAE.0000000000002789. |
Not provided
Not provided
Stage 1 of the study was a patient-masked, dose-escalation, paired-eye comparison and the Investigator was not masked. Stage 2 was a parallel-group, sham-controlled, paired-eye comparison. Investigators were masked as to dose received for patients in the active treatment groups. No patients from Stage 1 were enrolled in Stage 2.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 400 µg Brimonidine Tartrate Implant Stage 1 | Stage 1: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6. |
| FG001 | 200 µg Brimonidine Tartrate Implant Stage 1 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| 200 µg Brimonidine Tartrate Implant | Drug | 200 µg brimonidine tartrate implant in the study eye on Day 1 and Month 6. |
|
|
| Sham (no implant) | Other | Sham in one or both eyes on Day 1 and Month 6. |
|
| Baseline, Month 3, Month 6, Month 9, Month 18, Month 24 |
| 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. | Baseline, 24 Months |
| Change From Baseline in Contrast Sensitivity in the Study Eye | Change from baseline in contrast sensitivity in the study eye is measured using a Pelli-Robson contrast sensitivity chart at 1 meter. The contrast sensitivity chart contains letters that are darkest at the top and then get progressively lighter. Scores range from 0 to 48 and are based on the number of letters read correctly. A negative change from baseline indicates a worsening in contrast sensitivity and a positive change from baseline indicates an improvement. | Baseline, 24 Months |
| Change From Baseline in Reading Speed in the Study Eye | Change from baseline in reading speed in the study eye is assessed using modified Bailey-Lovie word charts. Patients read the chart for 2 minutes and the numbers of words read correctly per minute are totaled. An increase in the number of words read correctly indicates an improvement and a decrease in the number of words read correctly indicates a worsening. | Baseline, 24 Months |
| Sydney |
| New South Wales |
| Australia |
| Karlsruhe | Germany |
| Udine | Italy |
| Makati City | Philippines |
| Coimbra | Portugal |
| Seoul | South Korea |
Stage 1: 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
| FG002 | 400 µg Brimonidine Tartrate Implant Stage 2 | Stage 2: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6. |
| FG003 | 200 µg Brimonidine Tartrate Implant Stage 2 | Stage 2: 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6. |
| FG004 | Sham (no Implant) Stage 2 | Stage 2: sham in both eyes on Day 1 and Month 6. |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 400 µg Brimonidine Tartrate Implant Stage 1 | Stage 1: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6. |
| BG001 | 200 µg Brimonidine Tartrate Implant Stage 1 | Stage 1: 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6. |
| BG002 | 400 µg Brimonidine Tartrate Implant Stage 2 | Stage 2: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6. |
| BG003 | 200 µg Brimonidine Tartrate Implant Stage 2 | Stage 2: 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6. |
| BG004 | Sham (no Implant) Stage 2 | Stage 2: sham in both eyes on Day 1 and Month 6. |
| BG005 | 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 | Change From Baseline in Size of Geographic Atrophy Lesion Area in the Study Eye | Change from baseline in size of geographic atrophy lesion area in the study eye is based on fundus photography as read by an independent Reading Center. Photographs are taken with a specialized microscope with an attached camera to photograph the interior of the eye, including the retina and optic disc. A positive change from baseline indicates an increase in size of geographic atrophy lesion area (worsening; disease progression). Data are reported in disc area where 1 disc area = 1.767 millimeters squared (mm^2). | Intent-to-Treat: All randomized patients who participated in Stage 2 | Posted | Mean | Standard Deviation | Disc Area | Baseline, Month 12 |
|
|
| ||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Size of Geographic Atrophy Lesion Area in the Study Eye | Change from baseline in size of geographic atrophy lesion area in the study eye is based on fundus photography as read by an independent Reading Center. Photographs are taken with a specialized microscope with an attached camera to photograph the interior of the eye, including the retina and optic disc. A positive change from baseline indicates an increase in size of geographic atrophy lesion area (worsening; disease progression). Data are reported in disc area where 1 disc area = 1.767 millimeters squared (mm^2). | Intent-to-Treat: All randomized patients who participated in Stage 2 | Posted | Mean | Standard Deviation | Disc Area | Baseline, Month 3, Month 6, Month 9, Month 18, Month 24 |
| ||||||||||||||||||||||||||||||||||
| 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 who participated in Stage 2 | Posted | Mean | Standard Deviation | Number of Letters Read Correctly | Baseline, 24 Months |
| ||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Contrast Sensitivity in the Study Eye | Change from baseline in contrast sensitivity in the study eye is measured using a Pelli-Robson contrast sensitivity chart at 1 meter. The contrast sensitivity chart contains letters that are darkest at the top and then get progressively lighter. Scores range from 0 to 48 and are based on the number of letters read correctly. A negative change from baseline indicates a worsening in contrast sensitivity and a positive change from baseline indicates an improvement. | Intent-to-Treat: All randomized patients who participated in Stage 2 | Posted | Mean | Standard Deviation | Number of Letters Read Correctly | Baseline, 24 Months |
| ||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Reading Speed in the Study Eye | Change from baseline in reading speed in the study eye is assessed using modified Bailey-Lovie word charts. Patients read the chart for 2 minutes and the numbers of words read correctly per minute are totaled. An increase in the number of words read correctly indicates an improvement and a decrease in the number of words read correctly indicates a worsening. | Intent-to-Treat: All randomized patients who participated in Stage 2 | Posted | Mean | Standard Deviation | Words per Minute (wpm) | Baseline, 24 Months |
|
Not provided
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. 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 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 µg Brimonidine Tartrate Implant | Stage 1 and 2 combined: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6. | 14 | 43 | 38 | 43 | ||
| EG001 | 200 µg Brimonidine Tartrate Implant | Stage 1 and 2 combined: 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6. | 20 | 51 | 47 | 51 | ||
| EG002 | Sham (no Implant) Stage 2 | Stage 2: sham in both eyes on Day 1 and Month 6. | 9 | 23 | 20 | 23 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA version 10.0 | Systematic Assessment |
| |
| Angina Unstable | Cardiac disorders | MedDRA version 10.0 | Systematic Assessment |
| |
| Cardiac Failure Congestive | Cardiac disorders | MedDRA version 10.0 | Systematic Assessment |
| |
| Coronary Artery Disease | Cardiac disorders | MedDRA version 10.0 | Systematic Assessment |
| |
| Acute Myocardial Infarction | Cardiac disorders | MedDRA version 10.0 | Systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | MedDRA version 10.0 | Systematic Assessment |
| |
| Myocardial Infarction | Cardiac disorders | MedDRA version 10.0 | Systematic Assessment |
| |
| Angina Pectoris | Cardiac disorders | MedDRA version 10.0 | Systematic Assessment |
| |
| Aortic Valve Stenosis | Cardiac disorders | MedDRA version 10.0 | Systematic Assessment |
| |
| Atrial Flutter | Cardiac disorders | MedDRA version 10.0 | Systematic Assessment |
| |
| Mitral Valve Stenosis | Cardiac disorders | MedDRA version 10.0 | Systematic Assessment |
| |
| Sick Sinus Syndrome | Cardiac disorders | MedDRA version 10.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA version 10.0 | Systematic Assessment |
| |
| Visual Acuity Reduced | Eye disorders | MedDRA version 10.0 | Non-systematic Assessment |
| |
| Abdominal Pain Lower | Gastrointestinal disorders | MedDRA version 10.0 | Non-systematic Assessment |
| |
| Diverticulum | Gastrointestinal disorders | MedDRA version 10.0 | Systematic Assessment |
| |
| Small Intestinal Obstruction | Gastrointestinal disorders | MedDRA version 10.0 | Systematic Assessment |
| |
| Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA version 10.0 | Systematic Assessment |
| |
| Oesophageal Stenosis | Gastrointestinal disorders | MedDRA version 10.0 | Systematic Assessment |
| |
| Diarrhoea Infectious | Infections and infestations | MedDRA version 10.0 | Non-systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA version 10.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA version 10.0 | Systematic Assessment |
| |
| Clostridium Difficile Colitis | Infections and infestations | MedDRA version 10.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA version 10.0 | Systematic Assessment |
| |
| Urinary Tract Infection Bacterial | Infections and infestations | MedDRA version 10.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA version 10.0 | Systematic Assessment |
| |
| Hip Fracture | Injury, poisoning and procedural complications | MedDRA version 10.0 | Systematic Assessment |
| |
| Spinal Compression Fracture | Injury, poisoning and procedural complications | MedDRA version 10.0 | Systematic Assessment |
| |
| Femoral Neck Fracture | Injury, poisoning and procedural complications | MedDRA version 10.0 | Systematic Assessment |
| |
| Road Traffic Accident | Injury, poisoning and procedural complications | MedDRA version 10.0 | Non-systematic Assessment |
| |
| Femur Fracture | Injury, poisoning and procedural complications | MedDRA version 10.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA version 10.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA version 10.0 | Systematic Assessment |
| |
| Flank Pain | Musculoskeletal and connective tissue disorders | MedDRA version 10.0 | Non-systematic Assessment |
| |
| Bowen's Disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 10.0 | Systematic Assessment |
| |
| Lung Squamous Cell Carcinoma Stage Unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 10.0 | Systematic Assessment |
| |
| Squamous Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 10.0 | Systematic Assessment |
| |
| Basal Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 10.0 | Systematic Assessment |
| |
| Bladder Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 10.0 | Systematic Assessment |
| |
| Laryngeal Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 10.0 | Systematic Assessment |
| |
| Malignant Melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 10.0 | Systematic Assessment |
| |
| Lung Cancer Metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 10.0 | Systematic Assessment |
| |
| Non-Hodgkin's Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 10.0 | Systematic Assessment |
| |
| Small Cell Lung Cancer Stage Unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 10.0 | Systematic Assessment |
| |
| Transitional Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 10.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA version 10.0 | Non-systematic Assessment |
| |
| Cerebrovascular Accident | Nervous system disorders | MedDRA version 10.0 | Systematic Assessment |
| |
| Carotid Artery Stenosis | Nervous system disorders | MedDRA version 10.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA version 10.0 | Non-systematic Assessment |
| |
| Intracranial Aneurysm | Nervous system disorders | MedDRA version 10.0 | Systematic Assessment |
| |
| Transient Ischaemic Attack | Nervous system disorders | MedDRA version 10.0 | Systematic Assessment |
| |
| Renal Failure Acute | Renal and urinary disorders | MedDRA version 10.0 | Systematic Assessment |
| |
| Stress Urinary Incontinence | Renal and urinary disorders | MedDRA version 10.0 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA version 10.0 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA version 10.0 | Systematic Assessment |
| |
| Urinary Retention | Renal and urinary disorders | MedDRA version 10.0 | Non-systematic Assessment |
| |
| Renal Failure | Renal and urinary disorders | MedDRA version 10.0 | Systematic Assessment |
| |
| Pulmonary Vascular Disorder | Respiratory, thoracic and mediastinal disorders | MedDRA version 10.0 | Systematic Assessment |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA version 10.0 | Systematic Assessment |
| |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA version 10.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA version 10.0 | Systematic Assessment |
| |
| Aortic Stenosis | Vascular disorders | MedDRA version 10.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA version 10.0 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA version 10.0 | Systematic Assessment |
| |
| Coronary Artery Disease | Cardiac disorders | MedDRA version 10.0 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA version 10.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA version 10.0 | Systematic Assessment |
| |
| Conjunctival Haemorrhage | Eye disorders | MedDRA version 10.0 | Systematic Assessment |
| |
| Punctate Keratitis | Eye disorders | MedDRA version 10.0 | Systematic Assessment |
| |
| Eye Pain | Eye disorders | MedDRA version 10.0 | Non-systematic Assessment |
| |
| Vitreous Floaters | Eye disorders | MedDRA version 10.0 | Non-systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA version 10.0 | Systematic Assessment |
| |
| Retinal Haemorrhage | Eye disorders | MedDRA version 10.0 | Systematic Assessment |
| |
| Posterior Capsule Opacification | Eye disorders | MedDRA version 10.0 | Systematic Assessment |
| |
| Visual Acuity Reduced | Eye disorders | MedDRA version 10.0 | Non-systematic Assessment |
| |
| Conjunctival Hyperaemia | Eye disorders | MedDRA version 10.0 | Systematic Assessment |
| |
| Vitreous Haemorrhage | Eye disorders | MedDRA version 10.0 | Systematic Assessment |
| |
| Vitreous Detachment | Eye disorders | MedDRA version 10.0 | Systematic Assessment |
| |
| Dental Caries | Gastrointestinal disorders | MedDRA version 10.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA version 10.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA version 10.0 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA version 10.0 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA version 10.0 | Systematic Assessment |
| |
| Ear Infection | Infections and infestations | MedDRA version 10.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA version 10.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA version 10.0 | Non-systematic Assessment |
| |
| Spinal Compression Fracture | Injury, poisoning and procedural complications | MedDRA version 10.0 | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA version 10.0 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA version 10.0 | Non-systematic Assessment |
| |
| Cerebrovascular Accident | Nervous system disorders | MedDRA version 10.0 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA version 10.0 | Systematic Assessment |
| |
| Sleep Apnoea Syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA version 10.0 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA version 10.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA version 10.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 10.0 | Non-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 |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
| 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 |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|
| Participants |
|
|