NCT01831947

Efficacy Study of Ranibizumab on Patients With Age-related Macular Degeneration.

Efficacy of Ranibizumab Treatment Every 2 Month Compared to Treatment on Demand on Patients With Choroidal Neo-vascularization (CNV) as a Consequence of Age-related Macular Degeneration (AMD)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial investigates the impact of intravitreal injection of Ranibizumab antibody on the acuteness of vision. Patients included are suffering from choroidal neo-vascularization (CNV) as a consequence of age-related macular degeneration (AMD). Initially, all patients get injections of 0.5 mg Ranibizumab in monthly intervals for 3 months. Subsequently, one group gets Ranibizumab in intervals of 2 months, whereas a second group is treated on demand. The primary end point of the study is the change of best-corrected visual acuity after 12 month. Secondary end points include the impact of Ranibizumab on morphological changes of the retina, the number of patients with gain or loss of 15 or more letters visual acuity after 12 months, changes in quality of life and the number of injections required during the first 12 months of treatment.

Conditions

• Macular Degeneration

Interventions

Type	Name	Description
BIOLOGICAL	Ranibizumab

Timeline

• Start date: 2010-04-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2013-04-15
• Last updated: 2013-04-15

Locations

1 site across 1 country: Germany