Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2026-02-23 @ 11:34 AM
Study NCT ID:
NCT02262260
Status:
COMPLETED
Last Update Posted:
2019-06-24
First Post:
2014-08-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Compare Safety/Efficacy of Labeled vs Wait-Extend Regimen of Lucentis in Turkish Patients With VI Due to DME
Sponsor:
Novartis Pharmaceuticals
Organization:
Study Overview
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
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SALUTE-D
Brief 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.
Detailed 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: