Ranibizumab 0.5 mg for Diabetic Macular Edema With Initial Intensive Treatment in the Real World Clinical Setting in Korea (Rising K) - Trial NCT05815212
Access comprehensive clinical trial information for NCT05815212 through Pure Global AI's free database. This phase not specified trial is sponsored by Novartis Pharmaceuticals and is currently Completed. The study focuses on Diabetic Macular Edema. Target enrollment is 87 participants.
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Study Focus
Observational
Sponsor & Location
Novartis Pharmaceuticals
Novartis
Timeline & Enrollment
N/A
Jun 11, 2021
Apr 04, 2022
Primary Outcome
Mean change from baseline in BCVA at Week 24 (±2 weeks)
Summary
This study was a multicenter, non-interventional, retrospective chart review of patients with
 DME who received ranibizumab 0.5 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 patient's 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 inclusion/exclusion 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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT05815212
Non-Device Trial