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The study will evaluate the safety and efficacy of the intravitreal dexamethasone implant in the study eye of vitrectomized subjects with diabetic macular edema. Subjects will be followed for 26 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 700 µg Dexamethasone Implant | Experimental | 700 µg dexamethasone implant in the study eye at Day 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone | Drug | 700 µg Dexamethasone Posterior Segment Drug Delivery System Applicator System at Day 1 in the study eye. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Central Retinal Thickness in the Study Eye | Central retinal thickness is assessed in the study eye by Optical Coherence Tomography (OCT). OCT is a laser-based, noninvasive, diagnostic system that provides high-resolution, three-dimensional images of the retina from which retinal thickness can be measured. A negative change from baseline in retinal thickness indicates an improvement and a positive change from baseline indicates a worsening. | Baseline, Week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye | BCVA is measured in the study eye 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 from baseline in the number of letters read correctly indicates improvement and a decrease from baseline in the number of letters read correctly 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 |
|---|---|---|---|---|---|---|
| Charlotte | North Carolina | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21487341 | Background | Boyer DS, Faber D, Gupta S, Patel SS, Tabandeh H, Li XY, Liu CC, Lou J, Whitcup SM; Ozurdex CHAMPLAIN Study Group. Dexamethasone intravitreal implant for treatment of diabetic macular edema in vitrectomized patients. Retina. 2011 May;31(5):915-23. doi: 10.1097/IAE.0b013e318206d18c. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 700 µg Dexamethasone Implant | 700 µg dexamethasone implant in the study eye at Day 1 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 700 µg Dexamethasone Implant | 700 µg dexamethasone implant in the study eye at Day 1 |
| 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 | Change From Baseline in Central Retinal Thickness in the Study Eye | Central retinal thickness is assessed in the study eye by Optical Coherence Tomography (OCT). OCT is a laser-based, noninvasive, diagnostic system that provides high-resolution, three-dimensional images of the retina from which retinal thickness can be measured. A negative change from baseline in retinal thickness indicates an improvement and a positive change from baseline indicates a worsening. | Intent to Treat: all enrolled patients | Posted | Mean | Standard Deviation | Microns | Baseline, Week 26 |
|
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The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs), and included all treated patients.
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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 | 700 µg Dexamethasone Implant | 700 µg dexamethasone implant in the study eye at Day 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac Failure Congestive | Cardiac disorders | MedDRA version 12.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival Haemorrhage | Eye disorders | MedDRA version 12.1 | 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 |
|---|---|
| D003907 | Dexamethasone |
| D002123 | Calcium Dobesilate |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| Baseline, Week 26 |
| Percentage of Patients With at Least 10 Letters of Improvement in BCVA From Baseline in the Study Eye | BCVA is measured in the study eye 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 improvement and a decrease in the number of letters read correctly indicates a worsening. | Baseline, Week 26 |
| Percentage of Patients With Fluorescein Leakage as Measured by Fluorescein Angiography (FA) in the Study Eye | Fluorescein leakage is measured in the study eye by FA. FA is a technique for examining the circulation of the retina (and detecting any leakage) using a dye-tracing method. The assessment of fluorescein leakage compared to baseline is categorized as Improved (leakage area decreased ≥ 10%), Unchanged (leakage area changed < 10%), and Worsened (leakage area increased ≥ 10%). | Baseline, Week 26 |
| Sydney |
| New South Wales |
| Australia |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye | BCVA is measured in the study eye 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 from baseline in the number of letters read correctly indicates improvement and a decrease from baseline in the number of letters read correctly indicates a worsening. | Intent to Treat: all enrolled patients | Posted | Mean | Standard Deviation | Letters Read Correctly | Baseline, Week 26 |
|
|
|
| Secondary | Percentage of Patients With at Least 10 Letters of Improvement in BCVA From Baseline in the Study Eye | BCVA is measured in the study eye 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 improvement and a decrease in the number of letters read correctly indicates a worsening. | Intent to treat: all enrolled patients | Posted | Number | Percentage of Patients | Baseline, Week 26 |
|
|
|
| Secondary | Percentage of Patients With Fluorescein Leakage as Measured by Fluorescein Angiography (FA) in the Study Eye | Fluorescein leakage is measured in the study eye by FA. FA is a technique for examining the circulation of the retina (and detecting any leakage) using a dye-tracing method. The assessment of fluorescein leakage compared to baseline is categorized as Improved (leakage area decreased ≥ 10%), Unchanged (leakage area changed < 10%), and Worsened (leakage area increased ≥ 10%). | Intent to Treat: all enrolled patients | Posted | Number | Percentage of Patients | Baseline, Week 26 |
|
|
|
| 14 |
| 55 |
| 55 |
| 55 |
| Anoxic Encephalopathy | Nervous system disorders | MedDRA version 12.1 | Systematic Assessment |
|
| Arteriovenous Fistula Thrombosis | Injury, poisoning and procedural complications | MedDRA version 12.1 | Systematic Assessment |
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| Atrioventricular Block Second Degree | Cardiac disorders | MedDRA version 12.1 | Systematic Assessment |
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| Carotid Artery Stenosis | Nervous system disorders | MedDRA version 12.1 | Systematic Assessment |
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| Cholecystitis Acute | Hepatobiliary disorders | MedDRA version 12.1 | Systematic Assessment |
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| Diabetic Foot Infection | Infections and infestations | MedDRA version 12.1 | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA version 12.1 | Systematic Assessment |
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| Ketoacidosis | Metabolism and nutrition disorders | MedDRA version 12.1 | Systematic Assessment |
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| Osteomyelitis | Infections and infestations | MedDRA version 12.1 | Systematic Assessment |
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| Pancreatitis | Gastrointestinal disorders | MedDRA version 12.1 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA version 12.1 | Systematic Assessment |
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| Presyncope | Nervous system disorders | MedDRA version 12.1 | Non-systematic Assessment |
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| Renal Failure | Renal and urinary disorders | MedDRA version 12.1 | Systematic Assessment |
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| Soft Tissue Infection | Infections and infestations | MedDRA version 12.1 | Systematic Assessment |
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| Transient Ischaemic Attack | Nervous system disorders | MedDRA version 12.1 | Systematic Assessment |
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| Conjunctival Hyperaemia | Eye disorders | MedDRA version 12.1 | Systematic Assessment |
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| Eye Pain | Eye disorders | MedDRA version 12.1 | Non-systematic Assessment |
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| Vitreous Haemorrhage | Eye disorders | MedDRA version 12.1 | Systematic Assessment |
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| Conjunctival Oedema | Eye disorders | MedDRA version 12.1 | Systematic Assessment |
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| Maculopathy | Eye disorders | MedDRA version 12.1 | Systematic Assessment |
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| Anterior Chamber Cell | Eye disorders | MedDRA version 12.1 | Systematic Assessment |
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| Foreign Body Sensation in Eyes | Eye disorders | MedDRA version 12.1 | Non-systematic Assessment |
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| Iritis | Eye disorders | MedDRA version 12.1 | Systematic Assessment |
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| Myodesopsia | Eye disorders | MedDRA version 12.1 | Systematic Assessment |
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| Intraocular Pressure Increased | Investigations | MedDRA version 12.1 | Systematic Assessment |
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| Renal Failure | Renal and urinary disorders | MedDRA version 12.1 | 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.
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| Title | Measurements |
|---|---|
|