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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
| Michigan State University | OTHER |
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The protocol will measure a number of cytokines in addition to vascular endothelial growth factor in response to 0.3mg Lucentis.
Lucentis injections are the current standard of care for diabetic macular edema. The only deviation from the standard of care in the current protocol is an aqueous tap before the first Lucentis injection and the fourth Lucentis injection for diabetic macular edema.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.3 mg Lucentis | Experimental | Aqueous Humor sample post injection of 0.3 mg Lucentis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lucentis | Drug | 0.3mg Lucentis |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Vascular Endothelial Growth Factor Levels | An aqueous humor specimen was obtained at baseline and at 12 weeks to determine if the levels of VEGF had decreased with treatment. | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vitreo-Retinal Associates | Grand Rapids | Michigan | 49546 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 0.3 mg Lucentis | Aqueous Humor sample post injection of 0.3 mg Lucentis Lucentis: 0.3mg Lucentis |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 0.3 mg Lucentis | Aqueous Humor sample post injection of 0.3 mg Lucentis Lucentis: 0.3mg Lucentis |
| 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 |
| 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 | Vascular Endothelial Growth Factor Levels | An aqueous humor specimen was obtained at baseline and at 12 weeks to determine if the levels of VEGF had decreased with treatment. | Posted | Mean | Inter-Quartile Range | pg/ml | 12 weeks |
|
|
3 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 | 0.3 mg Lucentis | Aqueous Humor sample post injection of 0.3 mg Lucentis Lucentis: 0.3mg Lucentis |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Louis C. Glazer, MD | Vitreo-Retinal Associates, P.C. | 1-616-285-1200 | glazerlc@vrapc.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 7, 2016 | May 3, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000069579 | Ranibizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OCT Central Subfield Thickness | Mean | Standard Deviation | microns |
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
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| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |