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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
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The purpose of this study is to evaluate the safety and effectiveness of intravitreal ranibizumab (Lucentis) in patients with fluid and blood leakage in their eyes due to ocular histoplasmosis.
Patients will be evaluated monthly for one year.
Participants will be assigned to one of two groups:
Group A will receive 3 monthly injections of ranibizumab followed by an as needed injection throughout the remainder of the study Group B will receive injections of ranibizumab on an as needed basis throughout the study
You cannot take part in this study if:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Monthly injections | Active Comparator | 3 monthly injections of ranibizumab followed by prn injections |
|
| PRN injections | Active Comparator | injections of ranibizumab on a prn basis from the start of the study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ranibizumab | Drug | 3 monthly injections of ranibizumab followed by prn injections for the remainder of the study |
|
| Measure | Description | Time Frame |
|---|---|---|
| incidence and severity of ocular adverse events as identified by eye examination | 1 year | |
| incidence and severity of other adverse events as identified by physical examination, subject reporting, and changes in vital signs | 12 mos |
| Measure | Description | Time Frame |
|---|---|---|
| mean change in visual acuity | 1 year | |
| mean change in central foveal thickness and total macular volume as obtained by ocular coherence tomography | 6 and 12 months | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Diana Holcomb, COA | Contact | 859-263-3900 | 145 | dholcomb@retinaky.com |
| Wanda Heath, BS, COT, CCRC | Contact | 859-263-3900 | 106 | wheath@retinaky.com |
| Name | Affiliation | Role |
|---|---|---|
| John Kitchens, MD | Retina Associates of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retina Associates of Kentucky | Recruiting | Lexington | Kentucky | 40509 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | May 31, 2013 | |
| Reset | Jul 31, 2013 | |
| Release | Aug 7, 2013 | |
| Reset | Oct 11, 2013 | |
| Release | Jun 13, 2014 | |
| Unrelease | Yes | |
| Release | Sep 23, 2014 | |
| Reset | Sep 23, 2014 | |
| Release | Sep 23, 2014 | |
| Reset | Sep 24, 2014 | |
| Release | Jun 9, 2015 | |
| Reset | Jun 11, 2015 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 31, 2013 | Jul 31, 2013 | |||
| Aug 7, 2013 |
| ID | Term |
|---|---|
| D006660 | Histoplasmosis |
| ID | Term |
|---|---|
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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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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| ranibizumab | Drug | prn injections of ranibizumab throughout the study |
|
|
| change in fluorescein angiographic outcomes |
| 12 months |
| mean number of injections | 12 mos |
| Oct 11, 2013 |
| Jun 13, 2014 | Yes |
| Sep 23, 2014 | Sep 23, 2014 |
| Sep 23, 2014 | Sep 24, 2014 |
| Jun 9, 2015 | Jun 11, 2015 |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |