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The purpose of this study is to compare visual improvement and total number of intraocular injections in eyes with macular edema following central retinal vein occlusion (CRVO)after initial treatment with Ozurdex (dexamethasone implant) or Avastin (bevacizumab).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Subjects randomized to this arm will receive one initial treatment with Ozurdex then treated with Avastin if needed. |
|
| Group 2 | Active Comparator | Subjects randomized to this arm will receive one initial treatment with Avastin then treated with Avastin if needed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ozurdex | Drug | Ozurdex, 0.7mg dexamethasone |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| The Change in Visual Acuity (Number of ETDRS Early Treatment Diabetic Retinopathy Study Letters), at Month 6 as Compared With Baseline in Each Treatment Arm | The change in visual acuity (number of ETDRS - Early Treatment Diabetic Retinopathy Study letters), at Month 6 as compared with baseline in each treatment arm | Baseline - Month 6 |
| The Total Number of Additional Avastin Injections Following Initial Treatment in Each Treatment Arm | Total Number of addiitonal Avastin injections during study- From baseline to Month 6 | Baseline - Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Central Mean Thickness Based on OCT | Change in Central Mean Thickness based on OCT from baseline to Month 6t | Baseline to 6 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vincent A Deramo, M.D | Long Island Vitreoretinal Consultants | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retina Vitreous Center | Toms River | New Jersey | 08755 | United States | ||
| Long Island Vitreoretinal Consultants |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ozurdex & Avastin | Subjects randomized to this arm will receive one initial treatment with Ozurdex then treated with Avastin if needed. Ozurdex: Ozurdex, 0.7mg dexamethasone Avastin: Formulated as a 1.25mg/0.05ml sterile solution given by intravitreal injection monthly as needed. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Avastin | Drug | Formulated as a 1.25mg/0.05ml sterile solution given by intravitreal injection monthly as needed. |
|
|
| Great Neck |
| New York |
| 11021 |
| United States |
| Long Island Vitreoretinal Consultants | Hauppauge | New York | 11788 | United States |
| Long Island Vitreoretinal Consultants | Riverhead | New York | 11901 | United States |
| Avastin Only |
Subjects randomized to this arm will receive one initial treatment with Avastin then treated with Avastin if needed. Avastin: Formulated as a 1.25mg/0.05ml sterile solution given by intravitreal injection monthly as needed. |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 | Subjects randomized to this arm will receive one initial treatment with Ozurdex then treated with Avastin if needed. Ozurdex: Ozurdex, 0.7mg dexamethasone Avastin: Formulated as a 1.25mg/0.05ml sterile solution given by intravitreal injection monthly as needed. |
| BG001 | Group 2 | Subjects randomized to this arm will receive one initial treatment with Avastin then treated with Avastin if needed. Avastin: Formulated as a 1.25mg/0.05ml sterile solution given by intravitreal injection monthly as needed. |
| BG002 | 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, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | 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 | The Change in Visual Acuity (Number of ETDRS Early Treatment Diabetic Retinopathy Study Letters), at Month 6 as Compared With Baseline in Each Treatment Arm | The change in visual acuity (number of ETDRS - Early Treatment Diabetic Retinopathy Study letters), at Month 6 as compared with baseline in each treatment arm | Posted | Mean | Full Range | Letters Gain/Loss | Baseline - Month 6 |
|
|
| |||||||||||||||||||||||||||||
| Primary | The Total Number of Additional Avastin Injections Following Initial Treatment in Each Treatment Arm | Total Number of addiitonal Avastin injections during study- From baseline to Month 6 | Posted | Mean | Full Range | Injections | Baseline - Month 6 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Change in Central Mean Thickness Based on OCT | Change in Central Mean Thickness based on OCT from baseline to Month 6t | Posted | Mean | Full Range | Microns on OCT | Baseline to 6 Months |
|
|
Adverse Events were collected for the study period of 6 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 | Group 1 | Subjects randomized to this arm will receive one initial treatment with Ozurdex then treated with Avastin if needed. Ozurdex: Ozurdex, 0.7mg dexamethasone Avastin: Formulated as a 1.25mg/0.05ml sterile solution given by intravitreal injection monthly as needed. | 0 | 14 | 0 | 14 | 0 | 14 |
| EG001 | Group 2 | Subjects randomized to this arm will receive one initial treatment with Avastin then treated with Avastin if needed. Avastin: Formulated as a 1.25mg/0.05ml sterile solution given by intravitreal injection monthly as needed. | 0 | 13 | 0 | 13 | 0 | 13 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vincent A. Deramo, MD | Long Island Vitreoretinal Consultants | 5164660390 | 222 | vaderamo@gmail.com |
| ID | Term |
|---|---|
| D008269 | Macular Edema |
| D012170 | Retinal Vein Occlusion |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D020246 | Venous Thrombosis |
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D002123 | Calcium Dobesilate |
| D003907 | Dexamethasone |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| 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 |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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| >=65 years |
|
| Male |
|
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