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Search / Trial NCT06984822

Evaluation of Serum- and OCT Biomarkers in Patients With DME Treated With Anti-VEGF or Dexamethasone Implant

Launched by VASTRA GOTALAND REGION · May 19, 2025

Trial Information

Current as of July 21, 2025

Not yet recruiting

Keywords

Optical Coherence Tomography

ClinConnect Summary

This clinical trial is studying how certain biological markers in the blood and eye scans relate to how well patients with diabetic macular edema (DME) respond to two types of treatments: an anti-VEGF injection or a dexamethasone implant. Diabetic macular edema is a condition that can cause vision problems in people with diabetes. The researchers want to see if these markers can help predict how well patients will do with these treatments. They will also compare results from patients who have not received any treatment for DME before.

To participate in the trial, individuals need to be between 65 and 74 years old and diagnosed with type I or type II diabetes. They must have DME that affects the center of their vision and certain specific conditions in their eyes. However, people who have had other eye diseases, recent treatments for DME, or certain eye surgeries may not be eligible. Participants can expect to undergo tests to check their eye health and blood samples will be taken to analyze the biomarkers. This study may help improve understanding and treatment options for DME in the future.

Gender

ALL

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.

About Vastra Gotaland Region

Vastra Gotaland Region is a prominent healthcare organization in Sweden, dedicated to advancing medical research and improving patient care through innovative clinical trials. As a sponsor, the region leverages its extensive network of hospitals and healthcare professionals to facilitate high-quality research initiatives that address pressing health challenges. With a commitment to ethical standards and patient safety, Vastra Gotaland Region strives to foster collaboration between researchers, clinicians, and patients, ensuring that clinical trials contribute valuable insights and advancements in medical science.

Locations

Mölndal, , Sweden

Patients applied

0 patients applied

Trial Officials

Marita Grönlund, M.D. Prof

Principal Investigator

Göteborg University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported