NCT06984822 Evaluation of Serum- and OCT Biomarkers in Patients With DME Treated With Anti-VEGF or Dexamethasone Implant
| NCT ID | NCT06984822 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Vastra Gotaland Region |
| Condition | Diabetic Macular Edema |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2025-08-01 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2025-08-01 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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).
Eligibility 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.
Contact & Investigator
Marita Grönlund, M.D. Prof
PRINCIPAL INVESTIGATOR
Göteborg University
Frequently Asked Questions
Who can join the NCT06984822 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Diabetic Macular Edema. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06984822 currently recruiting?
Yes, NCT06984822 is actively recruiting participants. Contact the research team at imadeddin.abu.ishkheidem@vgregion.se for enrollment information.
Where is the NCT06984822 trial being conducted?
This trial is being conducted at Mölndal, Sweden, Mölndal, Sweden.
Who is sponsoring the NCT06984822 clinical trial?
NCT06984822 is sponsored by Vastra Gotaland Region. The principal investigator is Marita Grönlund, M.D. Prof at Göteborg University. The trial plans to enroll 150 participants.