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
- Are there results?
- Not yet: the study is under way
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.
- More trials run by Vastra Gotaland RegionThe sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Serum and Ocular Coherence Tomography Biomarkers in Patients With Diabetic Macular Edema Treated With Anti-VEGF or Dexamethasone Implant
- ClinicalTrials.gov ID
- NCT06984822
- Acronym / sponsor ID
- BiomarkerOCT / BiomarkerOCT
- Conditions
- Diabetic Macular Edema, Visual Impairment, Diabetes Mellitus, Hyperglycaemia (Diabetic), Oxidative Stress, Vascular Endothelial Growth Factor
- Keywords
- optical coherence tomography
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 22 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Prospective, observational, controlled, non-randomized, monocenter study.
| Arm | Type | Receives |
|---|---|---|
| Anti-VEGF treated patients | Experimental | Drug: Anti-VEGF treatmentPatients with ongoing anti-VEGF treatment |
| Dexamethasone treated patients | Experimental | Device: Dexamethasone implantPatients with ongoing Dexamethasone implant treatment |
| Patients not previously treated for DME | Experimental | Other: Treatment with intravitreal anti-VEGF OR Dexamethasone implantTreatment-naive patients (neither anti-VEGF treatment nor Dexamethasone implant treatment) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anti-VEGF treatmentTreatment with intravitreal anti-VEGF treatment | Drug | Anti-VEGF treated patients |
| Dexamethasone implantAlso: Dexamethasone treatmentTreatment with Dexamethasone implant | Device | Dexamethasone treated patients |
| Treatment with intravitreal anti-VEGF OR Dexamethasone implantAlso: Anti-VEGF OR Dexamethasone treatmentTreatment with intravitreal anti-VEGF OR treatment with Dexamethasone implant | Other | Patients not previously treated for DME |
Primary outcome
Serum levels of Vascular Endothelial Growth Factor (VEGF)
Time frame: At baseline (and for group 3. naive patients also after 4 weeks)
Serum levels of VEGF
Serum levels of interleukin 6 (IL-6)
Time frame: At baseline (and for group 3. naive patients also after 4 weeks)
Serum levels of IL-6
Serum levels of interleukin 8 (IL-8)
Time frame: At baseline (and for group 3. naive patients also after 4 weeks)
Serum levels of IL-8
Serum levels of monocyte chemoattractant protein 1 (MCP-1)
Time frame: At baseline (and for group 3. naive patients also after 4 weeks)
Serum levels of MCP-1
Serum levels of angiopoietin 2 (Ang-2)
Time frame: At baseline (and for group 3. naive patients also after 4 weeks)
Serum levels of Ang-2
Serum levels of placental growth factor (PlGF)
Time frame: At baseline (and for group 3. naive patients also after 4 weeks)
Serum levels of PIGF
Serum levels of tumor necrosis factor alpha (TNF-a)
Time frame: At baseline (and for group 3. naive patients also after 4 weeks)
Serum levels of TNF-a
Serum levels of intercellular adhesion molecule 1 (ICAM-1)
Time frame: At baseline (and for group 3. naive patients also after 4 weeks)
Serum levels of ICAM-1
4 secondary outcomes
Incidence of OCT-biomarker disorgani-zation of retinal inner layers (DRIL)
Time frame: At baseline and after 4 weeks
Incidence of OCT-biomarker disruption of retinal outer layers (DROL)
Time frame: At baseline and after 4 weeks
Incidence of OCT-biomarker hyper-reflective foci (HRF)
Time frame: At baseline and after 4 weeks
Incidence of OCT-biomarker subretinal fluid (SRF)
Time frame: At baseline and after 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marita Grönlund, M.D. Prof principal investigator
Göteborg University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Imadeddin Abu Ishkheidem, M.D. (+46738744867, imadeddin.abu.ishkheidem@vgregion.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum levels of Vascular Endothelial Growth Factor (VEGF) (time frame: At baseline (and for group 3. naive patients also after 4 weeks)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.