Diabetic Macular EdemaNCT05815212
Ranibizumab 0.5 mg for Diabetic Macular Edema With Initial Intensive Treatment in the Real World Clinical Setting in Korea (Rising K)
An observational study of Diabetic Macular Edema, run by Novartis Pharmaceuticals at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Macular Edema
- How many people
- 87 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 Jun 2021to 4 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This was a retrospective, noninterventional cohort study
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Diabetic Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with DME | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline in BCVA at Week 24 (±2 weeks)
Measured: Baseline and Week 24 (±2 weeks)
Secondary outcomes (20)
Mean change from baseline in CST at Week 24
Measured: Baseline and Week 24
Percent change in IRF or SRF status from baseline to Week 24
Measured: Baseline and Week 24
Percentage of patients with ≥5-, ≥10- and ≥15-letter gains from baseline to Week 24
Measured: Baseline and Week 24
Percentage of patients with improved edema from baseline to Week 24
Measured: Baseline and Week 24
Percentage of patients with ≥2-step DRSS improvement from baseline to Week 24
Measured: Baseline and Week 24
Percentage of patients with ≥2-step DRSS worsening from baseline to Week 24
Measured: Baseline and Week 24
Mean change from baseline in BCVA at Week 24 according to the quartile of CST change
Measured: Baseline and Week 24
Mean change from baseline in BCVA at Week 24 according to the IRF or SRF status change
Measured: Baseline and Week 24
Total number of ranibizumab doses administered during the 24-week follow-up period
Measured: 24 weeks
Change from baseline in BCVA at Week 24 for patients with and without prior history of anti-VEGF therapy
Measured: Baseline and Week 24
Change from baseline in CST at Week 24 for patients with and without prior history of anti-VEGF therapy
Measured: Baseline and Week 24
Percent change in IRF status from baseline to Week 24 for patients with and without prior history of anti-VEGF therapy
Measured: Baseline and Week 24
Percent change in SRF status from baseline to Week 24 for patients with and without prior history of anti-VEGF therapy
Measured: Baseline and Week 24
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
Measured: Baseline and Week 24
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
Measured: Baseline and Week 24
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
Measured: Baseline and Week 24
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
Measured: Baseline and Week 24
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
Measured: Baseline and Week 24
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
Measured: Baseline and Week 24
Total number of ranibizumab doses administered during the 24-week follow-up for patients with and without prior history of anti-VEGF therapy
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start11 Jun 2021
- Primary completion4 Apr 2022
- Study completion4 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Macular EdemaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05815212
- Sponsor's protocol ID
- CRFB002DKR04
- Status last verified
- Apr 2023
- First submitted
- 4 Apr 2023
- Last updated
- 18 Apr 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ranibizumab 0.5 mg for Diabetic Macular Edema With Initial Intensive Treatment in the Real World Clinical Setting in Korea (Rising K)
- ClinicalTrials.gov ID
- NCT05815212
- Acronym / sponsor ID
- CRFB002DKR04
- Conditions
- Diabetic Macular Edema
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 11 Jun 2021 (actual)
- Primary completion
- 4 Apr 2022 (actual)
- Study completion
- 4 Apr 2022 (actual)
- First posted
- 18 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with DME | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This was a retrospective, noninterventional cohort study
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mean change from baseline in BCVA at Week 24 (±2 weeks)
Time frame: Baseline and Week 24 (±2 weeks)
20 secondary outcomes
Mean change from baseline in CST at Week 24
Time frame: Baseline and Week 24
Percent change in IRF or SRF status from baseline to Week 24
Time frame: Baseline and Week 24
Percentage of patients with ≥5-, ≥10- and ≥15-letter gains from baseline to Week 24
Time frame: Baseline and Week 24
Percentage of patients with improved edema from baseline to Week 24
Time frame: Baseline and Week 24
Percentage of patients with ≥2-step DRSS improvement from baseline to Week 24
Time frame: Baseline and Week 24
Percentage of patients with ≥2-step DRSS worsening from baseline to Week 24
Time frame: Baseline and Week 24
Mean change from baseline in BCVA at Week 24 according to the quartile of CST change
Time frame: Baseline and Week 24
Mean change from baseline in BCVA at Week 24 according to the IRF or SRF status change
Time frame: Baseline and Week 24
Total number of ranibizumab doses administered during the 24-week follow-up period
Time frame: 24 weeks
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
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
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
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
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
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Macular Edema, run by Novartis Pharmaceuticals at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change from baseline in BCVA at Week 24 (±2 weeks) (time frame: Baseline and Week 24 (±2 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023.