Status:
COMPLETED
Efficacy and Safety of Intravitreal Bevacizumab in the Treatment of Choroidal Neovascular Membranes Associated to High Myopia
Lead Sponsor:
Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
Collaborating Sponsors:
Fondo de Investigacion Sanitaria
Conditions:
Myopia
Choroidal Neovascularization
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ...
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 patie...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00967850
Start Date
April 1 2008
End Date
June 1 2011
Last Update
October 31 2024
Active Locations (7)
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1
INGO
Santiago de Compostela, La Coruña, Spain, 15706
2
Hospital General Reina Sofía
Espinardo, Murcia, Spain, 30100
3
Clínica Universitaria de Navarra
Pamplona, Navarre, Spain, 31080
4
Instituto Oftalmológico de Alicante
Alicante, Spain, 03015