Intravitreal injection
DrugIntravitreal injection of 1,25 mg in 0,05 ml
Other names: Avastin
NCT Number: NCT00967850
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 3
INGO, Santiago de Compostela, La Coruña, Spain
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intravitreal injection of 1,25 mg in 0,05 ml
Other names: Avastin
Photodynamic therapy on day 1 as described in standard clinical guidelines.
Time frame: Every month during first year - Every three months during the second year
Time frame: Every month during first year - Every three months during the second year
Time frame: Every treatment visit - Once per month during the first 3 months. Reteatments depending on Visual acuitiy evolution and retinal thickness
Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
Other
Phase III Study of Efficacy and Safety of Intravitreal Bevacizumab in the Treatment of Choroidal Neovascular Membranes Associated to High Myopia
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