NCT02140411

Efficacy and Safety of Lucentis® (Ranibizumab Intravitreal Injections) in Chilean Patients With Diabetic Macular Edema.

Chilean Interventional Open Label Pilot Study, to Assess the Efficacy and Safety of Lucentis® (Ranibizumab Intravitreal Injections) in Patients With Visual Impairment Due to Diabetic Macular Edema.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Ranibizumab is a humanized anti-vascular endothelial growth factor (VEGF) monoclonal antibody fragment approved in Chile by the Instituto de Salud Pública for the treatment of diabetic macular edema (DME), retinal vein occlusion and age-related macular degeneration. Currently, there is limited epidemiologic information in Chile regarding the incidence of DME and limited experience of anti-VEGF hospital therapy. This study will evaluate the efficacy of intravitreal ranibizumab in Chilean DME patients, to investigate the anatomical and functional improvement following this treatment and to increase the local experience regarding the use of anti-VEGF in the treatment of diabetic macular edema.

Conditions

• Retinal Vein Occlusion
• Age Related Macular Degeneration

Interventions

Type	Name	Description
DRUG	Ranibizumab Intravitreal injections	Ranibizumab intravitreal injections 3 months 1 per month and after PRN treatment.

Timeline

• Start date: 2015-04-25
• Primary completion: 2016-12-21
• Completion: 2016-12-21
• First posted: 2014-05-16
• Last updated: 2019-02-20
• Results posted: 2019-02-20

Locations

1 site across 1 country: Chile