Efficacy and Safety of Intravitreal Bevacizumab in the Treatment of Choroidal Neovascular Membran… (NCT00967850) | Clinical Trial Compass
CompletedPhase 3
Efficacy and Safety of Intravitreal Bevacizumab in the Treatment of Choroidal Neovascular Membranes Associated to High Myopia
Spain56 participantsStarted 2008-04
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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.
What they're measuring
1
Improvement in Visual Acuity assessed by ETDRS
Timeframe: Every month during first year - Every three months during the second year
Trial details
NCT IDNCT00967850
SponsorInstituto Universitario de OftalmobiologĂa Aplicada (Institute of Applied Ophthalmobiology) - IOBA