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The purpose of this protocol is to determine wether the initial protocol in the treatment of subfoveal choroidal neovascularization associated to High Myopia with bevacizumab intravitreal injections is more effective when using 3 doses vs using 1 single dose in the load period
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3 Month Load with 9 month p.r.n. | Active Comparator | 3 Monthly bevacizumab injections with 9 p.r.n. monthly doses if patient meets the treatment criteria for each monthly visit |
|
| Single Dose Load Phase | Experimental | Single dose treatment with bevacizumab, followed by 2 sham injections if conditions are met in the months 2 and 3, and followed with bevacizumab monthly p.r.n. as per protocol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevazizumab intravitreal injection | Drug | Intravitreal injection of bevacizumab |
|
| Measure | Description | Time Frame |
|---|---|---|
| Early Treatment Diabetic Retinopathy Study (ETDRS) Best corrected visual acuity | Differences in best corrected visual acuity in the exit visit compared to the one obtained at screening visit | 1 Year |
| Retinal thickness | Retinal thickness assessed by Spectral Domain Optical Coherence Tomography | 1 Year |
| Number of total injections during study | Total count of bevacizumab intravitreal injections during the whole study | 1 Year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jose Maria Ruiz-Moreno, MD PhD | University of Castilla-La Mancha | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHUS - Fundacion IDICHUS | Santiago de Compostela | La Coruña | 15706 | Spain | ||
| Clinica Universitaria de Navarra |
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| Pamplona |
| Navarre |
| 31080 |
| Spain |
| Complejo Hospitalario de Albacete | Albacete | 02006 | Spain |
| Hospital Clinico Universitario San Carlos | Madrid | 28010 | Spain |
| Hospital Universitario Ramón y Cajal | Madrid | 28031 | Spain |
| Hospital Reina Sofia | Murcia | 30100 | Spain |
| Hospital Virgen de Valme | Seville | 41013 | Spain |
| Hospital Virgen de la Macarena | Seville | 41071 | Spain |
| Hospital General Universitario de Valencia | Valencia | Spain |
| IOBA - Instituto Universitario de Oftalmobiologia Aplicada | Valladolid | 47011 | Spain |
| Hospital Universitario Rio Hortega | Valladolid | 47012 | Spain |
| ID | Term |
|---|---|
| D020256 | Choroidal Neovascularization |
| ID | Term |
|---|---|
| D015862 | Choroid Diseases |
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
| D009389 | Neovascularization, Pathologic |
| D008679 | Metaplasia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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