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This study will assess the safety and efficacy of FA Intravitreal Inserts in subjects with macular edema secondary to RVO.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluocinolone Acetonide 0.2 µg/day | Experimental | 0.2 µg/day |
|
| Fluocinolone Acetonide 0.5 µg/day | Experimental | 0.5 µg/day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluocinolone Acetonide | Drug | 0.2 µg/day |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity | To compare the 3 month best corrected visual acuity to baseline in subjects diagnosed with macular edema secondary to retinal vein occlusion. BCVA will be measured according to the standard procedure developed for ETDRS at 4 meters or 3 meters if the electronic (E)-ETDRS system is employed. | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky Department of Ophthalmology | Lexington | Kentucky | United States | |||
| Ophthalmic Consultants of Boston |
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| ID | Title | Description |
|---|---|---|
| FG000 | Fluocinolone Acetonide: 0.2 µg/Day | Fluocinolone Acetonide: 0.2 µg/day |
| FG001 | Fluocinolone Acetonide: 0.5 µg/Day | Fluocinolone Acetonide: 0.5 µg/day |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fluocinolone Acetonide 0.2 µg/Day | 0.2 µg/day Fluocinolone Acetonide: 0.2 µg/day |
| BG001 | Fluocinolone Acetonide 0.5 µg/Day | 0.5 µg/day Fluocinolone Acetonide: 0.5 µg/day |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Visual Acuity | To compare the 3 month best corrected visual acuity to baseline in subjects diagnosed with macular edema secondary to retinal vein occlusion. BCVA will be measured according to the standard procedure developed for ETDRS at 4 meters or 3 meters if the electronic (E)-ETDRS system is employed. | Posted | Mean | Standard Error | Letters | 3 months |
|
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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 | Fluocinolone Acetonide: 0.2 µg/Day | Fluocinolone Acetonide: 0.2 µg/day |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kathleen Billman, Senior Director, Scientific Affairs | Alimera Sciences, Inc. | 678-527-1302 | kathleen.billman@alimerasciences.com |
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| ID | Term |
|---|---|
| D008269 | Macular Edema |
| D012170 | Retinal Vein Occlusion |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D005446 | Fluocinolone Acetonide |
| ID | Term |
|---|---|
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Fluocinolone Acetonide |
| Drug |
0.5 µg/day |
|
| Boston |
| Massachusetts |
| United States |
| Cole Eye Institute | Cleveland | Ohio | 44195 | United States |
| Death |
|
| Study Terminated |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Number | participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 8 |
| 14 |
| 13 |
| 14 |
| EG001 | Fluocinolone Acetonide: 0.5 µg/Day | Fluocinolone Acetonide: 0.5 µg/day | 4 | 6 | 6 | 6 |
| Arrhythmia | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Retinal detachment | Eye disorders | MedDRA | Systematic Assessment | #Study eye |
|
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
|
| Pseudomonas infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Major depression | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Mental disorder | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Bladder obstruction | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Orthopnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Cardiac pacemaker replacement | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Cataract operation | Surgical and medical procedures | MedDRA | Systematic Assessment | #Study eye |
|
| Cataract operation | Surgical and medical procedures | MedDRA | Systematic Assessment | #Fellow eye |
|
| Angina pectoris | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Cerumen impaction | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA | Systematic Assessment |
|
| Cataract | Eye disorders | MedDRA | Systematic Assessment | #Study eye |
|
| Cataract | Eye disorders | MedDRA | Systematic Assessment | #Fellow eye |
|
| Cataract subcapsular | Eye disorders | MedDRA | Systematic Assessment | #Study eye |
|
| Conjunctival haemorrhage | Eye disorders | MedDRA | Systematic Assessment | #Study eye |
|
| Diabetic retinopathy | Eye disorders | MedDRA | Systematic Assessment | #Fellow eye |
|
| Diplopia | Eye disorders | MedDRA | Systematic Assessment | #Study eye |
|
| Diplopia | Eye disorders | MedDRA | Systematic Assessment | #Fellow eye |
|
| Dry eye | Eye disorders | MedDRA | Systematic Assessment | #Study eye |
|
| Dry eye | Eye disorders | MedDRA | Systematic Assessment | #Fellow eye |
|
| Eye irritation | Eye disorders | MedDRA | Systematic Assessment | #Study eye |
|
| Eye pain | Eye disorders | MedDRA | Systematic Assessment | #Study eye |
|
| Eye pain | Eye disorders | MedDRA | Systematic Assessment | #Fellow eye |
|
| Iris neovascularisation | Eye disorders | MedDRA | Systematic Assessment | #Study eye |
|
| Myodesopsia | Eye disorders | MedDRA | Systematic Assessment | #Study eye |
|
| Ocular hyperaemia | Eye disorders | MedDRA | Systematic Assessment | #Study eye |
|
| Optic atrophy | Eye disorders | MedDRA | Systematic Assessment | #Study eye |
|
| Optic disc haemorrhage | Eye disorders | MedDRA | Systematic Assessment | #Study eye |
|
| Optic disc vascular disorder | Eye disorders | MedDRA | Systematic Assessment | #Study eye |
|
| Papilloedema | Eye disorders | MedDRA | Systematic Assessment | #Study eye |
|
| Photophobia | Eye disorders | MedDRA | Systematic Assessment | #Study eye |
|
| Photopsia | Eye disorders | MedDRA | Systematic Assessment | #Study eye |
|
| Retinal aneurysm | Eye disorders | MedDRA | Systematic Assessment | #Fellow eye |
|
| Retinal haemorrhage | Eye disorders | MedDRA | Systematic Assessment | #Study eye |
|
| Retinal neovascularisation | Eye disorders | MedDRA | Systematic Assessment | #Study eye |
|
| Retinal oedema | Eye disorders | MedDRA | Systematic Assessment | #Study eye |
|
| Visual acuity reduced | Eye disorders | MedDRA | Systematic Assessment | #Study eye |
|
| Vitreous detachment | Eye disorders | MedDRA | Systematic Assessment | #Study eye |
|
| Vitreous detachment | Eye disorders | MedDRA | Systematic Assessment | #Fellow eye |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA | Systematic Assessment |
|
| Sensation of foreign body | General disorders | MedDRA | Systematic Assessment | #Study eye |
|
| Bronchitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Ear infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
|
| Pseudomonas infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Contrast media reaction | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Intraocular pressure increased | Investigations | MedDRA | Systematic Assessment | #Study eye |
|
| Intraocular pressure increased | Investigations | MedDRA | Systematic Assessment | #Fellow eye |
|
| Gout | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Hemianopia | Nervous system disorders | MedDRA | Systematic Assessment | #Study eye |
|
| Hemianopia | Nervous system disorders | MedDRA | Systematic Assessment | #Fellow eye |
|
| Anxiety | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Bladder obstruction | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Orthopnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
|
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| D020246 |
| Venous Thrombosis |
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D011083 |
| Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |