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| ID | Type | Description | Link |
|---|---|---|---|
| EUDRA CT 2007-006785-15 |
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| Name | Class |
|---|---|
| Fondo de Investigacion Sanitaria | OTHER |
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The purpose of this study is to determine the efficacy and safety of intravitreal injections of bevacizumab in High Myopia´s choroidal neovascularization versus the standard treatment of Photodynamic therapy.
Bad response in choroidal neovascularization in High myopia to Photodynamic therapy, which is the current approved treatment for that pathology, and the high incidence of this pathology in these patients, together with the great functional impact in their vision has fostered the search for new therapeutic strategies.
Intravitreal bevacizumab has already been tested in small series of patients with choroidal neovascularization associated to high myopia, whether as first treatment option or after the failure of photodynamic therapy with good results. In the published series an improvement of visual acuity is described after 1-2 injections, with a reduction in the macular edema and a good safety profile.
The lack of published trials that describe the efficacy of frequency of treatment in this pathology is the main reason for this trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravitreal Bevacizumab | Experimental | Intravitreal injections of bevacizumab |
|
| Visudyne | Active Comparator | Photodynamic Therapy with Visudyne |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravitreal Injection | Drug | Intravitreal injection of 1,25 mg in 0,05 ml |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in Visual Acuity assessed by ETDRS | Every month during first year - Every three months during the second year |
| Measure | Description | Time Frame |
|---|---|---|
| Central macular thickness with Ocular Coherence Tomography | Every month during first year - Every three months during the second year | |
| Complications that may arise from intravitreal injection | Every treatment visit - Once per month during the first 3 months. Reteatments depending on Visual acuitiy evolution and retinal thickness |
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Inclusion Criteria:
Patient at least 18 years old
High Myopia with one of the following:
Active subfoveal/juxtafoveal choroidal neovascularization confirmed by Fluorescein angiography and Ocular coherence tomography.
Visual acuity loss of less than 6 months of evolution related to the neovascular lesion, as stated by investigator´s opinion.
Patients previously treated with Photodynamic therapy are allowed to participate as long as the last treatment has been performed more than 3 months upon entering the study.
Signed informed consent.
Signed data protection consent.
Women of childbearing potential must provide a negative pregnancy test at inclusion and must commit to the use of a contraceptive treatment during the whole study.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| José Carlos Pastor Jimeno, MD, PhD | IOBA - Instituto Universitario de Oftalmobiología Aplicada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| INGO | Santiago de Compostela | La Coruña | 15706 | Spain | ||
| Hospital General Reina Sofía |
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| Photodynamic Therapy (Visudyne) | Drug | Photodynamic therapy on day 1 as described in standard clinical guidelines. |
|
| Espinardo |
| Murcia |
| 30100 |
| Spain |
| Clínica Universitaria de Navarra | Pamplona | Navarre | 31080 | Spain |
| Instituto Oftalmológico de Alicante | Alicante | 03015 | Spain |
| Hospital de la Vall d´Hebron | Barcelona | 08022 | Spain |
| Hospital Clínico San Carlos | Madrid | 28010 | Spain |
| IOBA - Instituto Universitario de Oftalmobiología Aplicada | Valladolid | 47011 | Spain |
| ID | Term |
|---|---|
| D009216 | Myopia |
| D020256 | Choroidal Neovascularization |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
| D015862 | Choroid Diseases |
| D014603 | Uveal Diseases |
| D009389 | Neovascularization, Pathologic |
| D008679 | Metaplasia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D058449 | Intravitreal Injections |
| D000068258 | Bevacizumab |
| D010778 | Photochemotherapy |
| D000077362 | Verteporfin |
| ID | Term |
|---|---|
| D056965 | Injections, Intraocular |
| D007267 | Injections |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| 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 |
| D003131 | Combined Modality Therapy |
| D010789 | Phototherapy |
| D011166 | Porphyrins |
| D045725 | Tetrapyrroles |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
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