Evaluation of Serum- and OCT Biomarkers in Patients With DME Treated With Anti-VEGF or Dexamethasone Implant
NCT ID: NCT06984822
Last Updated: 2025-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
150 participants
INTERVENTIONAL
2025-08-01
2028-12-31
Brief Summary
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Detailed Description
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Patients will be segregated into three primary cohorts: 1. patients currently treated with anti-VEGF, 2. patients currently treated with dexamethasone implants, and 3. patients not previously treated for DME (naive patients).
Patients blood will be analyzed for serum biomarkers known to correlate with DME: VEGF, IL-6, IL-8, MCP-1, Ang-2, PlGF, TNF-a, and ICAM-1. Blood will be drawn at study entry/baseline for all three groups, and for group 3. naive patients, blood will also be drawn after 4 weeks of treatment.
OCT scans will be performed at study entry/baseline and after 4 weeks of treatment for qualitative and quantitative assessment of the retina and choroid and scans will be analyzed for the following markers: DRIL, DROL, HRF, and subretinal fluid (SRF).
Based on the response to treatment, investigators plan to further divide patients into two subcategories: responders vs non-responders.
The investigators intent is to scrutinize any correlation between circulating serum biomarkers and imaging biomarkers.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Anti-VEGF treated patients
Patients with ongoing anti-VEGF treatment
Anti-VEGF treatment
Treatment with intravitreal anti-VEGF treatment
Dexamethasone treated patients
Patients with ongoing Dexamethasone implant treatment
Dexamethasone implant
Treatment with Dexamethasone implant
Patients not previously treated for DME
Treatment-naive patients (neither anti-VEGF treatment nor Dexamethasone implant treatment)
Treatment with intravitreal anti-VEGF OR Dexamethasone implant
Treatment with intravitreal anti-VEGF OR treatment with Dexamethasone implant
Interventions
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Anti-VEGF treatment
Treatment with intravitreal anti-VEGF treatment
Dexamethasone implant
Treatment with Dexamethasone implant
Treatment with intravitreal anti-VEGF OR Dexamethasone implant
Treatment with intravitreal anti-VEGF OR treatment with Dexamethasone implant
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* DME involving the center of the fovea with CFT more than 280 microns and the presence of intraretinal cysts.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Vastra Gotaland Region
OTHER_GOV
Responsible Party
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Principal Investigators
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Marita Grönlund, M.D. Prof
Role: PRINCIPAL_INVESTIGATOR
Göteborg University
Locations
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Sahlgrenska University Hospital, Department of Ophthalmology
Mölndal, , Sweden
Ögonmottagning Mölndal/SU
Mölndal, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Imadeddin Abu Ishkheidem, M.D.
Role: primary
Other Identifiers
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BiomarkerOCT
Identifier Type: -
Identifier Source: org_study_id
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