Diabetic Macular EdemaNCT06179030
Systemic and Local Inflammatory Biomarkers in the Treatment of Refractory Diabetic Macular Edema
An observational study of Diabetic Macular Edema and Inflammation, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
The current study aims to investigate the relationship between systemic inflammatory biomarkers and local inflammatory biomarkers on OCT in patients with treatment resistant diabetic macular edema(DME) and further explore the associations with treatment outcomes. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Diabetic Macular Edema, Inflammation
- What is being tested?
- serum samples and dexamethasone implant versus ranibizumab
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2022to 17 Oct 2023
- 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 to 90 years
- All sexes
- Adult, Older adult
Study population: treatment naive patients who were diagnosed with diabetic macular edema and had poor response to the 3 consecutive bevacizumab intravitreal injection loading phase.
Who may be able to join
- who had refractory DME after 3 consecutive initial bevacizumab therapy
- treatment-naive
Who cannot join
- who had underwent anti-vegf treatment previously
- systemic inflammatory disease
- who had ocular surgery 6 months prior to enrollment
- uncontrolled hypertension
- <18 years old
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Prof. Dr. Cemil Tascioglu City Hospital
Istanbul, Sisli, 34384
About this study
The current study aims to investigate the relationship between systemic inflammatory biomarkers and local inflammatory biomarkers on OCT in patients with treatment resistant diabetic macular edema(DME) and further explore the associations with treatment outcomes.
Read the detailed description
This study was designed as a prospective open-label non rondomised observational study. The study was registered between April 18, 2022 and October 18, 2023. It is planned to include 80 volunteer patients over the age of 18 who are being followed up with the diagnosis of naive DME in the Retina Department of Prof Dr Cemil Tascioglu City Hospital and had poor response to the 3 consecutive initial monthly intravitreal bevacizumab loading dose. It was planned to evaluate systemic and local(OCT biomarker) inflammatory biomarker levels before swiching intravitreal agents, which may include intravitreal ranibizumab or intravitreal dexamethasone implant. The markers planned to be checked in blood samples are: IL-6, IL-8, TNF-a, ICAM-1, MCP-1, VEGF, HbA1c, CRP, ESR, haemogram, creatinine, AST, ALT, cholesterol. Patients were followed up monthly for 3 months after the switching. It was aimed to evaluate the level of systemic inflammatory biomarkers and the associations with treatment effectiveness. In addition, local OCT biomarkers (serous macular detachment and hyperreflective foci, etc.) and their relationship with treatment results were examined.
- Conditions
- Diabetic Macular Edema, Inflammation
- Being tested
- serum samples, dexamethasone implant versus ranibizumab
- Keywords
- diabetic macular edema, biomarkers, inflammation, optical coherence tomography
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serum samplesDiagnostic test
The serum samples were taken from the patients at the 3rd month (switch point)
dexamethasone implant versus ranibizumabDrug
dexamethasone implant versus ranibizumab will be studied as a secondary outcome
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | switched from bevacizumab to ranibizumab 0.5 Receives: Diagnostic Test: serum samples; Drug: dexamethasone implant versus ranibizumab | |
| Group 2 | switched from bevacizumab to dexamethasone implant Receives: Diagnostic Test: serum samples; Drug: dexamethasone implant versus ranibizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
systemic inflammatory biomarkes correlates with OCT biomarkers and higher in poor responders
serum inflammatory biomarkers such as ICAM-1, MCP-1 , Il-6, IL-8, VEGF-A and TNFa will be studied. then, the levels of the aferometioned parameters will be compared with the treatment response and OCT parameters.
Measured: 6 months
Secondary outcomes (1)
The anatomical and visual recovery will be compared to dexamethasone versus ranibizumab
The groups will be compared regarding to anatomical and visual improvement. The anatomical improvement wil be assessed by central macular thickness measured by spectral domain OCT. The best corrected visual acuity change will be assessed by snellen and LogMAR.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2023
- Study start1 May 2022
- Primary completion17 Oct 2023
- Study completion17 Oct 2023
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 Saglik Bilimleri UniversitesiThe 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
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Büşra Çoban, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06179030
- Sponsor's protocol ID
- E-48670771
- Status last verified
- Dec 2023
- First submitted
- 5 Dec 2023
- Last updated
- 2 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systemic and Local Inflammatory Biomarkers in the Treatment of Refractory Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT06179030
- Acronym / sponsor ID
- E-48670771
- Conditions
- Diabetic Macular Edema, Inflammation
- Keywords
- diabetic macular edema, biomarkers, inflammation, optical coherence tomography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 17 Oct 2023 (actual)
- Study completion
- 17 Oct 2023 (actual)
- First posted
- 21 Dec 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.
The current study aims to investigate the relationship between systemic inflammatory biomarkers and local inflammatory biomarkers on OCT in patients with treatment resistant diabetic macular edema(DME) and further explore the associations with treatment outcomes.
Detailed description
This study was designed as a prospective open-label non rondomised observational study. The study was registered between April 18, 2022 and October 18, 2023. It is planned to include 80 volunteer patients over the age of 18 who are being followed up with the diagnosis of naive DME in the Retina Department of Prof Dr Cemil Tascioglu City Hospital and had poor response to the 3 consecutive initial monthly intravitreal bevacizumab loading dose. It was planned to evaluate systemic and local(OCT biomarker) inflammatory biomarker levels before swiching intravitreal agents, which may include intravitreal ranibizumab or intravitreal dexamethasone implant. The markers planned to be checked in blood samples are: IL-6, IL-8, TNF-a, ICAM-1, MCP-1, VEGF, HbA1c, CRP, ESR, haemogram, creatinine, AST, ALT, cholesterol. Patients were followed up monthly for 3 months after the switching. It was aimed to evaluate the level of systemic inflammatory biomarkers and the associations with treatment effectiveness. In addition, local OCT biomarkers (serous macular detachment and hyperreflective foci, etc.) and their relationship with treatment results were examined.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Diagnostic Test: serum samples, Drug: dexamethasone implant versus ranibizumabswitched from bevacizumab to ranibizumab 0.5 |
| Group 2 | – | Diagnostic Test: serum samples, Drug: dexamethasone implant versus ranibizumabswitched from bevacizumab to dexamethasone implant |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- treatment naive patients who were diagnosed with diabetic macular edema and had poor response to the 3 consecutive bevacizumab intravitreal injection loading phase.
Key inclusion criteria (2 listed)
- who had refractory DME after 3 consecutive initial bevacizumab therapy
- treatment-naive
Key exclusion criteria (5 listed)
- who had underwent anti-vegf treatment previously
- systemic inflammatory disease
- who had ocular surgery 6 months prior to enrollment
- uncontrolled hypertension
- <18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| serum samplesThe serum samples were taken from the patients at the 3rd month (switch point) | Diagnostic test | Group 1, Group 2 |
| dexamethasone implant versus ranibizumabdexamethasone implant versus ranibizumab will be studied as a secondary outcome | Drug | Group 1, Group 2 |
Primary outcome
systemic inflammatory biomarkes correlates with OCT biomarkers and higher in poor responders
Time frame: 6 months
serum inflammatory biomarkers such as ICAM-1, MCP-1 , Il-6, IL-8, VEGF-A and TNFa will be studied. then, the levels of the aferometioned parameters will be compared with the treatment response and OCT parameters.
1 secondary outcome
The anatomical and visual recovery will be compared to dexamethasone versus ranibizumab
Time frame: 6 months
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 2 Jan 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Inflammation, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
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 2 inclusion and 5 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 2 Jan 2024. 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 Turkey (Türkiye). 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?
systemic inflammatory biomarkes correlates with OCT biomarkers and higher in poor responders (time frame: 6 months). 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 2 Jan 2024.