NCT00970957

Safety and Effectiveness of Bevacizumab Intravitreal Injections in the Treatment of Macular Edema Secondary to Retinal Vein Occlusion

Study of the Safety and Efficacy of Bevacizumab Intravitreal Injections for the Treatment of Macular Edema Secondary to Retinal Vein Occlusions

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 107 (actual)
• Sponsor: Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Lack of an effective treatment for macular edema secondary to central retinal vein occlusion and the bad response to grid laser treatment in patients with macular edema secondary to branch retinal vein occlusion, together with the high incidence of the pathology and the great functional loss in the patients that suffer from it has motivated the search for new therapeutic approaches. In recent times, intravitreal bevacizumab has been tested in clinical practice in small series of patients with this pathology, whether as first treatment or after failure of grid laser treatment with good functional results in short series. However, no retreatment information is available, although preliminary results from published series are good.

Conditions

• Macular Edema
• Retinal Vein Occlusion

Interventions

Type	Name	Description
DRUG	Avastin Intravitreal Injection	Intravitreal injection of 1.25mg Avastin (Bevacizumab) per month, during the first 3 months. Retreatments will be required if visual acuity or macular edema thickness worsen as defined per protocol
DRUG	Sham Avastin Intravitreal Injection	Intravitreal Injection simulation with a syringe without needle. The rest of the procedure remains the same as if intravitreal injection were to be performed (antibiotic prophylaxis, local anesthesia, ...).

Timeline

• Start date: 2009-09-01
• Primary completion: 2013-02-01
• Completion: 2013-02-01
• First posted: 2009-09-03
• Last updated: 2014-03-19

Locations

13 sites across 1 country: Spain