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Completed

NCT Number: NCT05815212

Ranibizumab 0.5 mg for Diabetic Macular Edema With Initial Intensive Treatment in the Real World Clinical Setting in Korea (Rising K)

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.

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Key information

Conditions

Diabetic Macular Edema

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Investigative Site

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged ≥18 years at the start of ranibizumab treatment
  • Diagnosed with diabetes mellitus (type 1 or type 2)
  • Diagnosed with diabetic macular edema (DME)
  • Vision loss due to DME as judged by treating physician
  • Medical records of receiving at least 3 doses in 4 months (initial intensive treatment) since the first dose of ranibizumab between 01 December 2019 and 31 October 2020 (data up to 30 April 2021 were collected)
  • Records of BCVA and OCT at baseline and Week 24 (±2 weeks) after treatment with ranibizumab

Exclusion criteria

  • Contraindications to ranibizumab according to local label information
  • History of systemic or ocular anti-VEGF therapy or loser photocoagulation in the last 90 days before the first dose of ranibizumab
  • History of intraocular or periocular corticosteroids in the last 120 days before the first dose of ranibizumab
  • History of vitrectomy

Treatment and study plan

Primary outcomes

  1. Mean change from baseline in BCVA at Week 24 (±2 weeks)

    Time frame: Baseline and Week 24 (±2 weeks)

Secondary outcomes

  1. Mean change from baseline in CST at Week 24

    Time frame: Baseline and Week 24

  2. Percent change in IRF or SRF status from baseline to Week 24

    Time frame: Baseline and Week 24

  3. Percentage of patients with ≥5-, ≥10- and ≥15-letter gains from baseline to Week 24

    Time frame: Baseline and Week 24

  4. Percentage of patients with improved edema from baseline to Week 24

    Time frame: Baseline and Week 24

  5. Percentage of patients with ≥2-step DRSS improvement from baseline to Week 24

    Time frame: Baseline and Week 24

  6. Percentage of patients with ≥2-step DRSS worsening from baseline to Week 24

    Time frame: Baseline and Week 24

  7. Mean change from baseline in BCVA at Week 24 according to the quartile of CST change

    Time frame: Baseline and Week 24

  8. Mean change from baseline in BCVA at Week 24 according to the IRF or SRF status change

    Time frame: Baseline and Week 24

  9. Total number of ranibizumab doses administered during the 24-week follow-up period

    Time frame: 24 weeks

  10. Change from baseline in BCVA at Week 24 for patients with and without prior history of anti-VEGF therapy

    Time frame: Baseline and Week 24

  11. Change from baseline in CST at Week 24 for patients with and without prior history of anti-VEGF therapy

    Time frame: Baseline and Week 24

  12. Percent change in IRF status from baseline to Week 24 for patients with and without prior history of anti-VEGF therapy

    Time frame: Baseline and Week 24

  13. Percent change in SRF status from baseline to Week 24 for patients with and without prior history of anti-VEGF therapy

    Time frame: Baseline and Week 24

  14. Percentage of patients with ≥5-, ≥10- and ≥15-letter gains from baseline to Week 24 for patients with and without prior history of anti-VEGF therapy

    Time frame: Baseline and Week 24

  15. Percentage of patients with ≥15 and ≥30 improvement in CST from baseline to Week 24 for patients with and without prior history of anti-VEGF therapy

    Time frame: Baseline and Week 24

  16. Percentage of patients with ≥2-step DRSS improvement and worsening from baseline to Week 24 for patients with and without prior history of anti-VEGF therapy

    Time frame: Baseline and Week 24

  17. Change from baseline in BCVA at Week 24 according to the quartile of CST change for patients with and without prior history of anti-VEGF therapy

    Time frame: Baseline and Week 24

  18. Change from baseline in BCVA at Week 24 according to the IRF status change for patients with and without prior history of anti-VEGF therapy change

    Time frame: Baseline and Week 24

  19. Change from baseline in BCVA at Week 24 according to the SRF status change for patients with and without prior history of anti-VEGF therapy change

    Time frame: Baseline and Week 24

  20. Total number of ranibizumab doses administered during the 24-week follow-up for patients with and without prior history of anti-VEGF therapy

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 18, 2023
Registry last updated
Apr 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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