Diabetic Macular EdemaBiomarkerOCTNCT06984822
Evaluation of Serum- and OCT Biomarkers in Patients With DME Treated With Anti-VEGF or Dexamethasone Implant
A study testing Anti-VEGF treatment, Dexamethasone implant and Treatment with intravitreal anti-VEGF OR Dexamethasone implant in people with Diabetic Macular Edema and Visual Impairment, run by Vastra Gotaland Region at 2 sites in Sweden.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Macular Edema, Visual Impairment, Diabetes Mellitus
- What is being tested?
- Anti-VEGF treatment, Dexamethasone implant and Treatment with intravitreal anti-VEGF OR Dexamethasone implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesSweden
- Study dates
- 1 Aug 2025to 31 Dec 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden2 sites, 2 recruiting
- Recruiting
Sahlgrenska University Hospital, Department of Ophthalmology
Mölndal, 431 80
Sofia T Silfverswärd, PhD, MSc, +46761283085 ext. +46, sofia.toyra.silfversward@vgregion.se
- Not yet recruiting
Ögonmottagning Mölndal/SU
Mölndal, 43130
Imadeddin Abu Ishkheidem, M.D., +46738744867
Sofia Töyrä Silfverswärd, PhD, +46761283085, sofia.toyra.silfversward@vgregion.se
About this study
Official title: Evaluation of Serum and Ocular Coherence Tomography Biomarkers in Patients With Diabetic Macular Edema Treated With Anti-VEGF or Dexamethasone Implant
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).
Read the detailed description
This prospective, observational, controlled, non-randomized, monocenter study will include patients with DME at the Sahlgrenska University Hospital in Gothenburg, Sweden undergoing treatment with either anti-VEGF or dexamethasone implant, or those being previously untreated.
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
- Diabetic Macular Edema, Visual Impairment, Diabetes Mellitus, Hyperglycaemia (Diabetic), Oxidative Stress, Vascular Endothelial Growth Factor
- Being tested
- Anti-VEGF treatment, Dexamethasone implant, Treatment with intravitreal anti-VEGF OR Dexamethasone implant
- Keywords
- optical coherence tomography
- Medical subject headings
- Vision Disorders, Diabetes Mellitus, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-VEGF treatmentDrug
Treatment with intravitreal anti-VEGF treatment
Dexamethasone implantDevice
Also called Dexamethasone treatment
Treatment with Dexamethasone implant
Treatment with intravitreal anti-VEGF OR Dexamethasone implantOther
Also called Anti-VEGF OR Dexamethasone treatment
Treatment with intravitreal anti-VEGF OR treatment with Dexamethasone implant
| Study group | Role | What they receive |
|---|---|---|
| Anti-VEGF treated patients | Experimental | Patients with ongoing anti-VEGF treatment Receives: Drug: Anti-VEGF treatment |
| Dexamethasone treated patients | Experimental | Patients with ongoing Dexamethasone implant treatment Receives: Device: Dexamethasone implant |
| Patients not previously treated for DME | Experimental | Treatment-naive patients (neither anti-VEGF treatment nor Dexamethasone implant treatment) Receives: Other: Treatment with intravitreal anti-VEGF OR Dexamethasone implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum levels of Vascular Endothelial Growth Factor (VEGF)
Serum levels of VEGF
Measured: At baseline (and for group 3. naive patients also after 4 weeks)
Serum levels of interleukin 6 (IL-6)
Serum levels of IL-6
Measured: At baseline (and for group 3. naive patients also after 4 weeks)
Serum levels of interleukin 8 (IL-8)
Serum levels of IL-8
Measured: At baseline (and for group 3. naive patients also after 4 weeks)
Serum levels of monocyte chemoattractant protein 1 (MCP-1)
Serum levels of MCP-1
Measured: At baseline (and for group 3. naive patients also after 4 weeks)
Serum levels of angiopoietin 2 (Ang-2)
Serum levels of Ang-2
Measured: At baseline (and for group 3. naive patients also after 4 weeks)
Serum levels of placental growth factor (PlGF)
Serum levels of PIGF
Measured: At baseline (and for group 3. naive patients also after 4 weeks)
Serum levels of tumor necrosis factor alpha (TNF-a)
Serum levels of TNF-a
Measured: At baseline (and for group 3. naive patients also after 4 weeks)
Serum levels of intercellular adhesion molecule 1 (ICAM-1)
Serum levels of ICAM-1
Measured: At baseline (and for group 3. naive patients also after 4 weeks)
Secondary outcomes (4)
Incidence of OCT-biomarker disorgani-zation of retinal inner layers (DRIL)
Differences in frequencies for DRIL
Measured: At baseline and after 4 weeks
Incidence of OCT-biomarker disruption of retinal outer layers (DROL)
Differences in frequencies for OCT-biomarker DROL
Measured: At baseline and after 4 weeks
Incidence of OCT-biomarker hyper-reflective foci (HRF)
Differences in frequencies for OCT-biomarker HRF
Measured: At baseline and after 4 weeks
Incidence of OCT-biomarker subretinal fluid (SRF)
Differences in frequencies for OCT-biomarker SRF
Measured: At baseline and after 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2025
- Study start1 Aug 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Macular EdemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, observational, controlled, non-randomized, monocenter study.
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Marita Grönlund, M.D. Prof, Principal investigator, Göteborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06984822
- Sponsor's protocol ID
- BiomarkerOCT
- Acronym
- BiomarkerOCT
- Status last verified
- Apr 2025
- First submitted
- 5 May 2025
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No