Ignite Creation Date:
2024-05-06 @ 6:52 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05815212
Status:
COMPLETED
Last Update Posted:
2023-04-18
First Post:
2023-04-04
Brief Title:
Ranibizumab 05 mg for Diabetic Macular Edema With Initial Intensive Treatment in the Real World Clinical Setting in Korea Rising K
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
Ranibizumab 05 mg for Diabetic Macular Edema With Initial Intensive Treatment in the Real World Clinical Setting in Korea Rising K
Status:
COMPLETED
Status Verified Date:
2023-04
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:
None
Brief Summary:
This study was a multicenter non-interventional retrospective chart review of patients with DME who received ranibizumab 05 mg as initial intensive treatment in real-world clinical setting in Korea
Enrolled patients started receiving ranibizumab between 01 December 2019 and 31 October 2020 with records of receiving at least 3 doses in the first 4 months after starting treatment in the data collected until 30 April 2021 Subsequent dosing interval was determined by the treating physician based on the patients condition Data were collected for up to 24 weeks 2 weeks from the date of first dose of ranibizumab including best-corrected visual acuity BCVA and optical coherence tomography OCT results at Week 24 Subjects were identified by review of patient medical records and those who met the inclusionexclusion criteria were enrolled
The primary objective of this study was to evaluate the effectiveness of ranibizumab in patients with DME who received initial intensive treatment by analyzing the mean change in BCVA using data collected during the 24-week follow-up period Central subfield thickness CST intra-retinal fluid IRF sub-retinal fluid SRF edema improvement and Diabetic Retinopathy Severity Scale DRSS results were also assessed to further analyze the effectiveness of ranibizumab The total number of ranibizumab doses administered was obtained to determine the pattern of ranibizumab treatment in real-world clinical setting
All decisions regarding the clinical management and treatment of patients were made by the treating physician according to real-world routine practice independently of the study All data collected in this study were extracted from the patient medical records recorded in the process
Enrolled patients started receiving ranibizumab between 01 December 2019 and 31 October 2020 with records of receiving at least 3 doses in the first 4 months after starting treatment in the data collected until 30 April 2021 Subsequent dosing interval was determined by the treating physician based on the patients condition Data were collected for up to 24 weeks 2 weeks from the date of first dose of ranibizumab including best-corrected visual acuity BCVA and optical coherence tomography OCT results at Week 24 Subjects were identified by review of patient medical records and those who met the inclusionexclusion criteria were enrolled
The primary objective of this study was to evaluate the effectiveness of ranibizumab in patients with DME who received initial intensive treatment by analyzing the mean change in BCVA using data collected during the 24-week follow-up period Central subfield thickness CST intra-retinal fluid IRF sub-retinal fluid SRF edema improvement and Diabetic Retinopathy Severity Scale DRSS results were also assessed to further analyze the effectiveness of ranibizumab The total number of ranibizumab doses administered was obtained to determine the pattern of ranibizumab treatment in real-world clinical setting
All decisions regarding the clinical management and treatment of patients were made by the treating physician according to real-world routine practice independently of the study All data collected in this study were extracted from the patient medical records recorded in the process
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None