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NCT05815212
Ranibizumab 0.5 mg for Diabetic Macular Edema With Initial Intensive Treatment in the Real World Clinical Setting in Korea (Rising K)
trial in Diabetic Macular Edema in 87 participants. Completed in 4 April 2022.
4 April 2022
Quick facts
| Lead sponsor | Novartis Pharmaceuticals |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 87 |
| Start date | 11 June 2021 |
| Primary completion | 4 April 2022 |
| Estimated completion | 4 April 2022 |
| Sites | 1 location across South Korea |
Conditions studied
- Diabetic Macular Edema — all drugs for Diabetic Macular Edema →
Sponsor
Novartis Pharmaceuticals — full company profile →
Who can join
18 and older, any sex, with Diabetic Macular Edema. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05815212
- Europe PMC full search
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Related trials
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Other Novartis Pharmaceuticals trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05815212 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
- Last refreshed: 18 April 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05815212.
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