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This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of non-infectious intermediate or posterior uveitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Dexamethasone 350 µg |
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| 2 | Active Comparator | Dexamethasone 700 µg |
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| 3 | Sham Comparator | Sham |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone | Drug | Dexamethasone 350 µg; injection drug delivery system at Day 0 |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With Vitreous Haze (Ocular Inflammation) Score of Zero | Percentage of patients with Vitreous Haze Score of Zero at Week 8. Score is based on standardized scale of 0 to +4 where 0 equals no inflammation and +4 equals optic nerve head not visible (severe). | Week 8 |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With at Least a 15-Letter Improvement in Best Corrected Visual Acuity (BCVA) | Percentage of Patients with at least a 15-letter improvement in BCVA at Week 8 from Baseline. 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). The higher the number of letters read correctly, the better the vision (or visual acuity). An improvement in the number of letters read means that the vision has improved. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dallas | Texas | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23761087 | Derived | Lightman S, Belfort R Jr, Naik RK, Lowder C, Foster CS, Rentz AM, Cui H, Whitcup SM, Kowalski JW, Revicki DA. Vision-related functioning outcomes of dexamethasone intravitreal implant in noninfectious intermediate or posterior uveitis. Invest Ophthalmol Vis Sci. 2013 Jul 18;54(7):4864-70. doi: 10.1167/iovs.12-10981. | |
| 23411886 | Derived |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dexamethasone 350 µg | Dexamethasone 350 µg |
| FG001 | Dexamethasone 700 µg | Dexamethasone 700 µg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| dexamethasone | Drug | Dexamethasone 700 µg injection drug delivery system at Day 0 |
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| Sham injection | Drug | Sham injection at Day 0 |
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| Week 8 |
| Percentage of Patients With at Least a 10-Point Improvement in the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25)Score | Percentage of patients with at least a 10-Point Improvement in the NEI-VFQ-25 over-all composite score at Week 8 from Baseline. The NEI-VFQ-25 consists of 25 vision-targeted questions plus one general health question resulting in a score of 0-100 (100 represents best functionality). | Week 8 |
| Sydney |
| Australia |
| Vienna | Austria |
| São Paulo | São Paulo/SP | Brazil |
| Montreal | Quebec | Canada |
| Prague | Czechia |
| Paris | France |
| Heidelberg | Germany |
| Cholargós | Greece |
| Hyderabad | India |
| Petah Tikva | Israel |
| Gdansk | Poland |
| Coimbra | Portugal |
| Johannesburg | South Africa |
| Seoul | South Korea |
| Madrid | Spain |
| Lausanne | Switzerland |
| London | United Kingdom |
| Naik RK, Rentz AM, Foster CS, Lightman S, Belfort R Jr, Lowder C, Whitcup SM, Kowalski JW, Revicki DA. Normative comparison of patient-reported outcomes in patients with noninfectious uveitis. JAMA Ophthalmol. 2013 Feb;131(2):219-25. doi: 10.1001/2013.jamaophthalmol.102. |
| 21220619 | Derived | Lowder C, Belfort R Jr, Lightman S, Foster CS, Robinson MR, Schiffman RM, Li XY, Cui H, Whitcup SM; Ozurdex HURON Study Group. Dexamethasone intravitreal implant for noninfectious intermediate or posterior uveitis. Arch Ophthalmol. 2011 May;129(5):545-53. doi: 10.1001/archophthalmol.2010.339. Epub 2011 Jan 10. |
| FG002 |
| Sham |
Sham |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Dexamethasone 350 µg | Dexamethasone 350 µg |
| BG001 | Dexamethasone 700 µg | Dexamethasone 700 µg |
| BG002 | Sham | Sham |
| 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, Customized | Number | Participants |
| ||||||||||||||||
| 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 | Percentage of Patients With Vitreous Haze (Ocular Inflammation) Score of Zero | Percentage of patients with Vitreous Haze Score of Zero at Week 8. Score is based on standardized scale of 0 to +4 where 0 equals no inflammation and +4 equals optic nerve head not visible (severe). | Intent to Treat | Posted | Number | Percentage of Patients | Week 8 |
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| ||||||||||||||||||||||||||||||||
| Other Pre-specified | Percentage of Patients With at Least a 15-Letter Improvement in Best Corrected Visual Acuity (BCVA) | Percentage of Patients with at least a 15-letter improvement in BCVA at Week 8 from Baseline. 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). The higher the number of letters read correctly, the better the vision (or visual acuity). An improvement in the number of letters read means that the vision has improved. | Intent to Treat | Posted | Number | Percentage of Patients | Week 8 |
|
| |||||||||||||||||||||||||||||||||
| Other Pre-specified | Percentage of Patients With at Least a 10-Point Improvement in the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25)Score | Percentage of patients with at least a 10-Point Improvement in the NEI-VFQ-25 over-all composite score at Week 8 from Baseline. The NEI-VFQ-25 consists of 25 vision-targeted questions plus one general health question resulting in a score of 0-100 (100 represents best functionality). | Intent to Treat | Posted | Number | Percentage of Patients | Week 8 |
|
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The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated. The Intent-to-Treat population was used for the outcome measure analyses and is calculated as the number of patients that were randomized (or started the study).
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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 | Dexamethasone 350 µg | Dexamethasone 350 µg | 6 | 74 | 58 | 74 | ||
| EG001 | Dexamethasone 700 µg | Dexamethasone 700 µg | 7 | 76 | 61 | 76 | ||
| EG002 | Sham | Sham | 5 | 75 | 51 | 75 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Retinal Detachment | Eye disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Endophthalmitis | Eye disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Uveitis | Eye disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Necrotising retinitis | Eye disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Pupillary disorder | Eye disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Hypotony of eye | Eye disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Pelvic inflammatory disease | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| HIV test positive | Investigations | MedDRA (11.1) | Systematic Assessment |
| |
| Ketoacidosis | Metabolism and nutrition disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Ankylosing spondylitis | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Pancreatic Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.1) | Systematic Assessment |
| |
| Cerebellar infarction | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Cerebrovascular Accident | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival haemorrhage | Eye disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Intraocular pressure increased | Investigations | MedDRA (11.1) | Systematic Assessment |
| |
| Eye Pain | Eye disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Iridocyclitis | Eye disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Uveitis | Eye disorders | MedDRA (11.1) | Systematic Assessment |
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| Ocular discomfort | Eye disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Myodesopsia | Eye disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Ocular hypertension | Eye disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Conjunctival hyperaemia | Eye disorders | MedDRA (11.1) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Eye irritation | Eye disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Intermediate uveitis | Eye disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Visual acuity reduced | Eye disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Macular oedema | Eye disorders | MedDRA (11.1) | Systematic Assessment |
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| Eye pruritis | Eye disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Cataract subcapsular | Eye disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Eye swelling | Eye disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (11.1) | Non-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 |
|---|---|
| D015867 | Uveitis, Intermediate |
| D015866 | Uveitis, Posterior |
| ID | Term |
|---|---|
| D014605 | Uveitis |
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
| D015864 | Panuveitis |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| C005703 | salicylhydroxamic acid |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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| Between 45 and 65 years |
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| >65 years |
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| Male |
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