NCT00967850

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 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.

Conditions

• Myopia
• Choroidal Neovascularization

Interventions

Type	Name	Description
DRUG	Intravitreal Injection	Intravitreal injection of 1,25 mg in 0,05 ml
DRUG	Photodynamic Therapy (Visudyne)	Photodynamic therapy on day 1 as described in standard clinical guidelines.

Timeline

• Start date: 2008-04-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2009-08-28
• Last updated: 2024-10-31

Locations

7 sites across 1 country: Spain