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

Myopia Clinical Trial

Official title: Phase III Study of Efficacy and Safety of Intravitreal Bevacizumab in the Treatment of Choroidal Neovascular Membranes Associated to High Myopia

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Choroidal Neovascularization
• Myopia
• Neovascularization, Pathologic

• NCT number: NCT00967850
• Study type: Interventional
• Source: Instituto Universitario de Oftalmobiología Aplicada
• Status: Completed
• Phase: Phase 3
• Start date: April 2008
• Completion date: June 2011