Initial Treatment With Bevacizumab in Choroidal Neovascularization Associated to High Myopia (NCT01716026) | Clinical Trial Compass
CompletedPhase 3
Initial Treatment With Bevacizumab in Choroidal Neovascularization Associated to High Myopia
Spain66 participantsStarted 2012-10
Plain-language summary
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
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Active subfoveal/juxtafoveal choroidal neovascularization in high myopia confirmed by Fundus Fluorescein angiography and Optical Coherence Tomography
* Best corrected visual acuity loss with less than 6 months of evolution, caused mainly by the neovascular lesion (based in investigator´s criteria)
* No atrophy or fibrotic component that may prevent visual acuity improvement
* Patients previously treated with Photodynamic Therapy are allowed to participate in this study
* Signed informed consent
* Signed data protection consent
* Negative pregnancy test in potential childbearing women at screening, with accepted contraceptive method during the whole study
Exclusion Criteria:
* Previous vitreous surgery in study eye
* Tractional maculopathy or epiretinal membrane found in Optical Coherence Tomography
* Media opacities that may prevent correct fundus assessment
* Lack of posterior capsule integrity in pseudophakic patients
* Patients with great possibilities of not being able to attend to study visits / follow visit procedures (investigator´s criteria)
* Patients previously treated with intravitreal antiangiogenic injections
What they're measuring
1
Early Treatment Diabetic Retinopathy Study (ETDRS) Best corrected visual acuity
Timeframe: 1 Year
2
Retinal thickness
Timeframe: 1 Year
3
Number of total injections during study
Timeframe: 1 Year
Trial details
NCT IDNCT01716026
SponsorInstituto Universitario de OftalmobiologĂa Aplicada (Institute of Applied Ophthalmobiology) - IOBA