Efficacy and Safety of Intravitreal Bevacizumab in the Treatment of Choroidal Neovascular Membranes Associated to High Myopia

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
• Collaborator: Fondo de Investigacion Sanitaria
• Treatments: Bevacizumab; Verteporfin

Criteria

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.