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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
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This study examines two doses of Ranibizumab (0.5mg and 1.0mg) for the treatment of macular edema secondary to retinal vein occlusion in patients that have previously failed treatment with other macular edema treatments including bevacizumab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intravitreal ranibizumab 0.5mg | Experimental |
| |
| intravitreal ranibizumab 1.0mg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ranibizumab 0.5mg | Drug | Standard dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline BCVA | Vision was measured using a standard ETDRS chart at baseline and each subsequent monthly visit. | Baseline to month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Center Point Thickness | months 1-12 | |
| Change in Mean Best Corrected Visual Acuity From Baseline | months 1-12 | |
| Percentage of Patients With CFT Less Than 300um |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas O'Hearn, MD | Thomas Hanscom AMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| South Coast Retina | Huntington Beach | California | 92647 | United States | ||
| South Coast Retina |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intravitreal Ranibizumab 0.5mg | ranibizumab 0.5mg: Standard dose Patients were given six months of monthly treatment with the standard 0.5mg ranibizumab dose, followed by six months of evaluation and PRN treatment based upon pre-specified criteria. |
| FG001 | Intravitreal Ranibizumab 1.0mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ranibizumab 1.0mg | Drug | High dose |
|
|
| Month 6 and 12 |
| Excess Foveal Thickness | Month 6 and 12 |
| Total Number of Ranibizumab Injections | month 12 |
| Long Beach |
| California |
| 90807 |
| United States |
| Thomas Hanscom AMC | Santa Monica | California | 90404 | United States |
| South Coast Retina | Torrance | California | 90505 | United States |
ranibizumab 1.0mg: High dose Patients were given six months of monthly treatment with the 1.0mg ranibizumab dose, followed by six months of evaluation and PRN treatment based upon pre-specified criteria. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intravitreal Ranibizumab 0.5mg | ranibizumab 0.5mg: Standard dose |
| BG001 | Intravitreal Ranibizumab 1.0mg | ranibizumab 1.0mg: High dose |
| 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, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | Mean Change From Baseline BCVA | Vision was measured using a standard ETDRS chart at baseline and each subsequent monthly visit. | Posted | Mean | Standard Deviation | Letters (ETDRS chart) | Baseline to month 6 |
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| Secondary | Mean Change From Baseline in Center Point Thickness | Not Posted | months 1-12 | ||||||||||||||||||||||||||||||||||||
| Secondary | Change in Mean Best Corrected Visual Acuity From Baseline | Not Posted | months 1-12 | ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients With CFT Less Than 300um | Not Posted | Month 6 and 12 | ||||||||||||||||||||||||||||||||||||
| Secondary | Excess Foveal Thickness | Not Posted | Month 6 and 12 | ||||||||||||||||||||||||||||||||||||
| Secondary | Total Number of Ranibizumab Injections | Not Posted | month 12 |
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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 | Intravitreal Ranibizumab 0.5mg | ranibizumab 0.5mg: Standard dose | 2 | 8 | 0 | 8 | ||
| EG001 | Intravitreal Ranibizumab 1.0mg | ranibizumab 1.0mg: High dose | 0 | 6 | 0 | 6 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Breast Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Patient developed breast cancer during trial. It was treated by her oncologist. Not felt to be secondary to Ranibizumab. |
| ||
| Ruptured Retinal Macroaneurysm | Ear and labyrinth disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas O'Hearn MD | Thomas Hanscom AMC | 310-829-3303 | tohearn@gmail.com |
| ID | Term |
|---|---|
| D012170 | Retinal Vein Occlusion |
| D008269 | Macular Edema |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D020246 | Venous Thrombosis |
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
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| ID | Term |
|---|---|
| D000069579 | Ranibizumab |
| ID | Term |
|---|---|
| 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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| Male |
|