Choroidal Neovascularization, Myopia
Conditions
Keywords
High Myopia, Bevacizumab, Photodynamic therapy
Brief summary
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.
Detailed description
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.
Interventions
DRUGIntravitreal Injection
Intravitreal injection of 1,25 mg in 0,05 ml
DRUGPhotodynamic Therapy (Visudyne)
Photodynamic therapy on day 1 as described in standard clinical guidelines.
Sponsors
Fondo de Investigacion Sanitaria
Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient at least 18 years old * High Myopia with one of the following: * 6 or more sphere diopters in the study eye * Axial length of the eye greater than 26 millimeters * 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
* Previous vitrectomy surgery in the study eye. * Tractional maculopathy and/or epiretinal membrane evaluated by Ocular coherence tomography. * Opacities that may not allow correct fundus assessment. * Lack of integrity of the posterior lens capsule in pseudoaphakic patients. * Patients that may not want/be able to complete the study, based in the investigator opinion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in Visual Acuity assessed by ETDRS | Every month during first year - Every three months during the second year |
Secondary
| Measure | 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 |
Countries
Spain
Outcome results
None listed