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| Name | Class |
|---|---|
| Novartis | INDUSTRY |
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To evaluate the safety of intravitreal ranibizumab repeated injections in patients with diabetic macular edema regarding maintenance of retinal ganglion cell function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ranibizumab | Experimental | monthly ranibizumab (0,5 mg injected intravitreally in a standard fashion) until maximum visual acuity (VA) is achieved and remains stable for three consecutive months (for a minimum of 3 initial injections). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ranibizumab | Drug | monthly ranibizumab (0,5 mg injected intravitreally in a standard fashion) until maximum visual acuity (VA) is achieved and remains stable for three consecutive months (for a minimum of 3 initial injections). |
| Measure | Description | Time Frame |
|---|---|---|
| focal macular changes in full-field and photopic negative response (PhRN) amplitude (in µV) | The photopic negative response (PhNR) of the full-field cone electroretinograms (ERGs) is a functional indicator of retinal ganglion. The PhNR consists of a negative-going wave that follows the photopic cone b wave. The PhNR is selectively attenuated in patients with optic nerve disease and glaucoma, indicating that the PhNR can be an objective functional measure reflecting the sum of the total response of the retinal ganglion cells in the entire retina. | at Baseline and Months 3, 6, 9, 12 |
| Measure | Description | Time Frame |
|---|---|---|
| The mean change in BCVA | The mean change in best corrected visual acuity (BCVA) from baseline to month 12 | monthly, from baseline to Month 12 |
| the mean change in central macular thickness (CMT) |
| Measure | Description | Time Frame |
|---|---|---|
| assess adverse events | To assess adverse events during the twelve months of the study. | monthly, from Month 1 to Month 12 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mauricio Maia, MD | UNIFESP / HOSPITAL SÃO PAULO | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept of Ophthalmology - UNIFESP/Hospital São Paulo | São Paulo | São Paulo | 04023-062 | Brazil |
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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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To assess the mean change in central macular thickness (CMT), measured in spectral-domain optical coherence tomography (SD-OCT) from baseline to month 12
| monthly, from baseline to Month 12 |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |