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The purpose of this study is to evaluate the safety and tolerability of Ranibizumab in patients with Clinically Significant Diabetic Macular Edema (CSDME). It will also compare treatment outcomes for patients receiving 0.5mg Ranibizumab and higher doses of 1.0mg and 2.0mg Ranibizumab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.5mg transitioning to 2.0mg | Active Comparator | Ranibizumab-intravitreal injection |
|
| 1.0 mg transitioning to 2.0mg | Active Comparator | Ranibizumab-intravitreal injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ranibizumab | Drug | 0.5mg or 1.0mg intravitreal injection given monthly for 3 months then every other month if needed, for the first year.Patients may be treated monthly as needed. Patients in Cohort 1(the first 30 patients)will be eligible to receive treatment as needed with 2.0mg ranibizumab starting at month 24. Patients in Cohort 2(the remaining 20)will be eligible to receive treatment as needed with 2.0mg ranibizumab starting at month 12.Patients may receive 2.0mg ranibizumab for a period limited to 24 months following administration of the first 2.0mg dose. Patients completing 36 months will be eligible to be followed for an additional 24 months. Starting at Month 36, patients will be able to receive monthly, the assigned dose that they received/or could have received(if re-treatment criteria was met)at Month 35. 2/1/12 - the 2.0mg dose has been discontinued, all subjects will transition to the 0.5mg dose. |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate safety and tolerability of ranibizumab in patients with clinically significant diabetic macular edema | month 12 | |
| To compare the treatment of clinically significant diabetic macular edema with 0.5 mg of ranibizumab to 1.0 mg ranibizumab | month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in visual acuity as measured by ETDRS from baseline to month 12, 24 36,48 and 60 in each arm. | month 12, 24, 36, 48 and 60 | |
| Mean change in central retinal thickness on OCT from baseline to month 12, 24, 36, 48 and 60 in each arm | month 12, 24, 36,48 and 60 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philip J. Ferrone, MD | Long Island Vitreoretinal Consultants | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Long Island Vitreoretinal Consultants | Great Neck | New York | 11021 | United States | ||
| Long Island Vitreoretinal Consultants |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 30, 2015 | |
| Reset | Apr 10, 2015 | |
| Release | Mar 17, 2016 | |
| Reset | Apr 18, 2016 | |
| Release | Aug 24, 2017 | |
| Reset | Sep 20, 2017 | |
| Release | Sep 25, 2017 | |
| Reset | Oct 23, 2017 | |
| Release | Mar 18, 2019 | |
| Reset | Apr 8, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 30, 2015 | Apr 10, 2015 | |||
| Mar 17, 2016 |
| ID | Term |
|---|---|
| D000069579 | Ranibizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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|
| Changes observed on the fluorescein angiogram in each arm | Month 60 |
| Mean number of ranibizumab injections required in each arm | Month 60 |
| The need for "rescue therapy" with laser in each arm | Month 60 |
| Evaluate the efficacy and safety of ranibizumab in the fellow eye in the sub-group of patients who require treatment for clinically significant diabetic macular edema in the fellow eye | Month 60 |
| Hauppauge |
| New York |
| 11749 |
| United States |
| Apr 18, 2016 |
| Aug 24, 2017 | Sep 20, 2017 |
| Sep 25, 2017 | Oct 23, 2017 |
| Mar 18, 2019 | Apr 8, 2019 |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |