Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anti-VEGF treated patients | Experimental | Patients with ongoing anti-VEGF treatment |
|
| Dexamethasone treated patients | Experimental | Patients with ongoing Dexamethasone implant treatment |
|
| Patients not previously treated for DME | Experimental | Treatment-naive patients (neither anti-VEGF treatment nor Dexamethasone implant treatment) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anti-VEGF treatment | Drug | Treatment with intravitreal anti-VEGF treatment |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Serum levels of Vascular Endothelial Growth Factor (VEGF) | Serum levels of VEGF | At baseline (and for group 3. naive patients also after 4 weeks) |
| Serum levels of interleukin 6 (IL-6) | Serum levels of IL-6 | At baseline (and for group 3. naive patients also after 4 weeks) |
| Serum levels of interleukin 8 (IL-8) | Serum levels of IL-8 | 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 | At baseline (and for group 3. naive patients also after 4 weeks) |
| Serum levels of angiopoietin 2 (Ang-2) | Serum levels of Ang-2 | At baseline (and for group 3. naive patients also after 4 weeks) |
| Serum levels of placental growth factor (PlGF) | Serum levels of PIGF | 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 | At baseline (and for group 3. naive patients also after 4 weeks) |
| Serum levels of intercellular adhesion molecule 1 (ICAM-1) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of OCT-biomarker disorgani-zation of retinal inner layers (DRIL) | Differences in frequencies for DRIL | At baseline and after 4 weeks |
| Incidence of OCT-biomarker disruption of retinal outer layers (DROL) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Imadeddin Abu Ishkheidem, M.D. | Contact | +46738744867 | imadeddin.abu.ishkheidem@vgregion.se | |
| Sofia Töyrä Silfverswärd, PhD | Contact | 0761283085 | sofia.toyra.silfversward@vgregion.se |
| Name | Affiliation | Role |
|---|---|---|
| Marita Grönlund, M.D. Prof | Göteborg University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sahlgrenska University Hospital, Department of Ophthalmology | Recruiting | Mölndal | 431 80 | Sweden |
Not provided
Prospective, observational, controlled, non-randomized, monocenter study.
Not provided
Not provided
Not provided
Not provided
| Dexamethasone implant |
| Device |
Treatment with Dexamethasone implant |
|
|
| Treatment with intravitreal anti-VEGF OR Dexamethasone implant | Other | Treatment with intravitreal anti-VEGF OR treatment with Dexamethasone implant |
|
|
Serum levels of ICAM-1 |
| At baseline (and for group 3. naive patients also after 4 weeks) |
Differences in frequencies for OCT-biomarker DROL
| At baseline and after 4 weeks |
| Incidence of OCT-biomarker hyper-reflective foci (HRF) | Differences in frequencies for OCT-biomarker HRF | At baseline and after 4 weeks |
| Incidence of OCT-biomarker subretinal fluid (SRF) | Differences in frequencies for OCT-biomarker SRF | At baseline and after 4 weeks |
| Ögonmottagning Mölndal/SU | Not yet recruiting | Mölndal | 43130 | Sweden |
|
| ID | Term |
|---|---|
| D014786 | Vision Disorders |
| D003920 | Diabetes Mellitus |
| D006943 | Hyperglycemia |
| ID | Term |
|---|---|
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D005128 | Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
Not provided
Not provided