Evaluation of Serum- and OCT Biomarkers in Patients With DME Treated With Anti-VEGF or Dexamethas… (NCT06984822) | Clinical Trial Compass
RecruitingNot Applicable
Evaluation of Serum- and OCT Biomarkers in Patients With DME Treated With Anti-VEGF or Dexamethasone Implant
Sweden150 participantsStarted 2025-08-01
Plain-language summary
This study aims to investigate the association between serum biomarkers and clinical response to anti-VEGF or dexamethasone implant by assessing OCT-biomarkers in patients with diabetic macular edema, DME, and to compare these with a group of naive patients (those not previously treated for DME).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Type I or type II DM.
* DME involving the center of the fovea with CFT more than 280 microns and the presence of intraretinal cysts.
Exclusion Criteria:
* Prior history of any other macular disease.
* Previous treatment with dexamethasone implants in the last six months for those in the anti-VEGF group.
* Previous treatment with anti-VEGF in the last two months for those in the dexamethasone implant group.
* Prior vitreoretinal surgery.
* Previous laser treatment of the macula.
* Previous panretinal photocoagulation.
* Ocular surgery in the previous 3 months.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Serum levels of Vascular Endothelial Growth Factor (VEGF)
Timeframe: At baseline (and for group 3. naive patients also after 4 weeks)
2
Serum levels of interleukin 6 (IL-6)
Timeframe: At baseline (and for group 3. naive patients also after 4 weeks)
3
Serum levels of interleukin 8 (IL-8)
Timeframe: At baseline (and for group 3. naive patients also after 4 weeks)
4
Serum levels of monocyte chemoattractant protein 1 (MCP-1)
Timeframe: At baseline (and for group 3. naive patients also after 4 weeks)
5
Serum levels of angiopoietin 2 (Ang-2)
Timeframe: At baseline (and for group 3. naive patients also after 4 weeks)
6
Serum levels of placental growth factor (PlGF)
Timeframe: At baseline (and for group 3. naive patients also after 4 weeks)
7
Serum levels of tumor necrosis factor alpha (TNF-a)