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| Name | Class |
|---|---|
| Allergan | INDUSTRY |
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To measure the pro-permeability factors in the aqueous humor of patients with persistent/recurrent macular edema after an injection of Ozurdex.
To measure various pro-permeability factors in the aqueous humor of patients with persistent/recurrent macular edema despite prior treatment with anti-VEGF agents at baseline and at 4 weeks after intraocular injection of OZURDEX.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CRVO | Other | Central Retinal Vein Occlusion |
|
| BRVO | Other | Branch Retinal Vein Occlusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dexamethasone implant | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Had a >30% Decrease in the Aqueous Levels of Various Vasoactive Proteins 4 Weeks After an Injection of Ozurdex | Vasoactive protein arrays and Enzyme linked immunosorbent assays were done for patients at baseline and week 4 visit to measure the levels of various pro-permeability factors including VEGF, SDF-1 and Angiopoietin-2. | 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wilmer Eye Institute | Baltimore | Maryland | 21287 | United States |
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40 patients from the clinic population of the Wilmer Eye Institute were recruited,
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| ID | Title | Description |
|---|---|---|
| FG000 | CRVO | Central Retinal Vein Occlusion dexamethasone implant |
| FG001 | BRVO | Branch Retinal Vein Occlusion dexamethasone implant |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CRVO | Central Retinal Vein Occlusion dexamethasone implant |
| BG001 | BRVO | Branch Retinal Vein Occlusion dexamethasone implant |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Number of Participants Who Had a >30% Decrease in the Aqueous Levels of Various Vasoactive Proteins 4 Weeks After an Injection of Ozurdex | Vasoactive protein arrays and Enzyme linked immunosorbent assays were done for patients at baseline and week 4 visit to measure the levels of various pro-permeability factors including VEGF, SDF-1 and Angiopoietin-2. | All enrolled (23 CRVO and 17 BRVO) patients completed the study. All patients were injected with Ozurdex, however microarrays were run on only 11 CRVO and 17 BRVO patient samples. Microarray data from 11 CRVO and 11 BRVO patients was analyzed. | Posted | Number | participants | 4 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 | CRVO | Central Retinal Vein Occlusion dexamethasone implant |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Patient fell down the stairs and was hospitalized for a cerebral bleed. | Injury, poisoning and procedural complications |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Increase in IOP in study eye | Eye disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Peter A. Campochiaro | Johns Hopkins | 410-955-5106 | pcampo@jhmi.edu |
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| ID | Term |
|---|---|
| D012170 | Retinal Vein Occlusion |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D020246 | Venous Thrombosis |
| D013927 | Thrombosis |
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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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| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Branch Retinal Vein Occlusion dexamethasone implant |
|
|
| 1 |
| 23 |
| 8 |
| 23 |
| EG001 | BRVO | Branch Retinal Vein Occlusion dexamethasone implant | 2 | 17 | 5 | 17 |
| The patient was hospitalized for an infection | Infections and infestations |
|
| Patient fell and hit head on the back of a chair resulting in trauma and infection in the study eye | Injury, poisoning and procedural complications |
|
| The patient was hospitalized for stomach pain | Gastrointestinal disorders |
|
| Redness of study eye after drug injection | Eye disorders |
|
| Patient had an uneventful fall | General disorders |
|
There is a restriction on the PI regarding disclosure of study results, which will be updated once the manuscript is published.
| D016769 |
| Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| 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 |