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The purpose of this study is to identify Diabetic Macular Edema (DME) characteristics in eyes that show different response to treatment with anti-VEGF (vascular endothelial growth factor) injections of Lucentis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with DME | Patients with DME who need treatment with anti-VEGF injections of Lucentis. |
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| Measure | Description | Time Frame |
|---|---|---|
| Central Retinal Thickness (Change from screening) | Measured by Spectral Domain Optical Coherence Tomography (OCT) | Change from Screening at 3 Months |
| Presence of OCT diffuse macular edema (without cyst formation) (change from screening) | Change from Screening at 3 Months | |
| Presence of neurosensorial retinal detachment. (change from screening) | Change from Screening at 3 Months | |
| Degree of integrity of the photoreceptors in the inner/outer segments layer in the 1 mm centered in the fovea (change from screening) | Change from Screening at 3 Months | |
| Presence and extension of capillary occlusion (change from screening) | Change from Screening at 3 Months | |
| Area of macular leakage (intraretinal fluid volume and retinal thickness) (change frmo screening) | Change from Screening at 3 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Best Corrected Visual Acuity (BCVA) (Change from screening) | Change from Screening at 3 Months | |
| Central Retinal Thickness (change from screening) | Measured by Spectral Domain Optical Coherence Tomography (OCT) |
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Inclusion Criteria:
Exclusion Criteria:
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Diabetic Type 2 patients with clinically significant Diabetic Macular Edema with therapeutic indication for treatment with intravitreal injections of anti-VEGF Lucentis.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Clinical Trials - Association for Innovation and Biomedical Research on Light and Image | Coimbra | 3000-548 | Portugal |
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| Change from Screening at 6 Months |
| Presence (and location) of cysts in the retinal layers (change from screening) | Change from Screening at 6 Months |
| Presence of OCT diffuse macular edema (without cyst formation) (change from screening) | Change from Screening at 6 months |
| Presence of neurosensorial retinal detachment. (change from screening) | Change from Screening at 6 Months |
| Degree of integrity of the photoreceptors in the inner/outer segments layer in the 1 mm centered in the fovea (change from screening) | Change from Screening at 6 months |
| Presence and extension of capillary occlusion (change from screening) | Change from Screening at 6 Months |
| Area of macular leakage (intraretinal fluid volume and retinal thickness) (change from screening) | Change from Screening at 6 Months |
| Best Corrected Visual Acuity (change from screening) | Change from Screening at 6 Months |