Blood and OCT biomarkers in people with diabetic macular edema receiving anti-VEGF or dexamethasone implant
Official title: Evaluation of Serum and Ocular Coherence Tomography Biomarkers in Patients With Diabetic Macular Edema Treated With Anti-VEGF or Dexamethasone Implant
Run by Vastra Gotaland Region · NCT06984822 · Data updated 2026-11-12
This project will test whether blood markers and OCT imaging signs can predict how people with diabetic macular edema respond to anti-VEGF injections or a dexamethasone eye implant.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | Vastra Gotaland Region Government |
| Locations | 2 sites (Mölndal and 1 other locations) |
| Status | Recruiting |
| Started | August 1, 2025 |
| Main results expected | December 31, 2028 |
| Study ends | December 31, 2028 |
| Registry record updated | November 21, 2025 |
| Trial ID | NCT06984822 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with type 1 or type 2 diabetes who have center-involving DME with central foveal thickness over 280 microns and intraretinal cysts are ideal candidates.
✕Probably not a fit
Patients with other macular diseases, recent vitreoretinal surgery, recent macular laser or recent intraocular surgery are excluded and unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, observational, non-randomized single-center study at Sahlgrenska University Hospital that compares three groups: patients on anti-VEGF, patients on dexamethasone implant, and treatment-naive patients. Blood will be sampled for circulating biomarkers (VEGF, IL-6, IL-8, MCP-1, Ang-2, PlGF, TNF-α, ICAM-1) at baseline and at four weeks for the naive group after initiating treatment. OCT scans at baseline and four weeks will be analyzed for retinal and choroidal imaging biomarkers including DRIL, DROL, hyperreflective foci, and subretinal fluid. Patients will be categorized as responders or non-responders and correlations between serum and imaging biomarkers and clinical response will be examined.
Why it matters
Potential benefit: If successful, the findings could help doctors predict which patients will respond better to anti-VEGF versus dexamethasone implant, allowing more personalized DME treatment.
How similar studies have gone: Previous studies have reported associations between some serum or OCT markers and treatment response in DME, but results have been inconsistent and the head-to-head comparison across anti-VEGF and steroid implants is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Sahlgrenska University Hospital, Department of Ophthalmology
Mölndal, Sweden Recruiting -
Ögonmottagning Mölndal/SU
Mölndal, Sweden Not yet recruiting
Study contacts
- Principal investigator: Marita Grönlund, M.D. Prof — Göteborg University
- Study coordinator: Imadeddin Abu Ishkheidem, M.D.
- Email: imadeddin.abu.ishkheidem@vgregion.se
- Phone: +46738744867
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.