Compare Safety/Efficacy of Labeled vs Wait-Extend Regimen of Lucentis in Turkish Patients With VI Due to DME — SALUTE-D  

Diabetic Macular Edema Clinical Trial

Official title: A Randomized, Open-label Non-inferiority Study to Compare Safety and Efficacy of Labeled Versus Wait and Extend Regimen of Lucentis (Ranibizumab) in Turkish Patients With Visual Impairment Due to Diabetic Macular Edema.

Status Completed

Clinical Trial Summary

To explore a more clinical feasible treatment regime with ranibizumab for DME to provide satisfactory treatment effect with a lower number of visits and injections.

Clinical Trial Description

Diabetes mellitus (DM) is the most common endocrine disease in developed countries, with prevalence estimates ranging between 2 to 5% of the world's population. Diabetic retinopathy (DR) and diabetic macular edema (DME) are common microvascular complications in patients with diabetes and may have a sudden and debilitating impact on visual acuity (VA), eventually leading to blindness. DME is a frequent manifestation of DR and is the major cause of visual loss in patients with DR. If left untreated, >50% of patients lose >2 lines of visual acuity (VA) within 2 years. DME mostly affects the working-age population, imposing a significant burden both on society and on individual patients - a burden that is expected to increase with the rising prevalence of diabetes. ;

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema

• NCT number: NCT02262260
• Study type: Interventional
• Source: Novartis
• Status: Completed
• Phase: Phase 3
• Start date: December 12, 2014
• Completion date: September 12, 2017