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Expiry of study drug - no replacement available.
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| Name | Class |
|---|---|
| Araim Pharmaceuticals, Inc. | INDUSTRY |
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ARA 290-DMO is a prospective, open label, interventional, single centre, investigator led, phase II trial to examine the effect of ARA 290 on diabetic macular oedema in patients with type 1 or 2 diabetes.
The aim or primary objective of the study was to determine whether ARA 290 administered at a daily dose of 4mg subcutaneously for 12 weeks to patients with diabetes mellitus (DM) and DMO would have a beneficial effect on mean change in best corrected visual acuity (BCVA) from baseline values to week 12.
Diabetic retinopathy a very most common cause of sight loss in people of working age. Sight loss occurs in diabetes because of diabetic macular oedema (DMO) and/or proliferative diabetic retinopathy (PDR), both are complications of diabetes in the eye.
In DMO fluid accumulates in the macula, the area responsible for our central sight. As the fluid accumulates the sight drops. The current treatments for DMO include laser and anti VEGF drugs and steroids. Anti VEGF drugs have been very helpful in the treatment of DMO. However, anti VEGF drugs need to be given by an injection into the eye, an Ophthalmologist (eye specialist) or a specialist nurse (a nurse trained for this purpose) will need to deliver this treatment to patients with DMO in the hospital.
Furthermore, patients require injections every four weeks during the first months of treatment and long term treatment is required. Moreover, not all patients respond to anti VEGFs: In 40% of patients the sight may not improve despite these injections. Because many patients with DMO have DMO in both eyes, injections need to be given in both eyes to many patients.
Given the above facts there appeared a clear need to develop new treatments for people with DMO. ARA 290 is a drug that has marked anti-inflammatory properties and has an effect in preventing the death of cells. As inflammation is known to play a role in the occurrence of DMO, it was thought that ARA 290 could potentially be helpful in treating patients with this condition. In light of this, the Investigators carried out this study to find out if ARA 290 was effective in drying the fluid in DMO. If this treatment was successful, benefits may have included a reduction of the demands on health care services and patient benefits of: self administration of the drug at home by the patients; a reduction in hospital visits; treatment of both eyes at once, reduced risks associated with injections; a more pleasant treatment (subcutaneous injection versus an injection into the eye).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Other | Subcutaneous daily injection of ARA 290 at a dose of 4mg for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ARA290 | Drug | 4 mg subcutaneous injections of ARA290 over an 84 day period |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Outcome - Best corrected distance visual acuity. | Best corrected distance visual acuity will be obtained in both eyes by a trained optometrist using the Early Treatment Diabetic Retinopathy Study (ETDRS) charts at baseline and at week 12. The EDTRS total score will be recorded and used for the analysis. | From baseline to week 12 (+/- 7 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Outcome - Central subfield thickness | Central subfield retinal thickness (CST), as obtained in the central 1 mm area, will be determined by spectral domain optical coherence tomography (SD-OCT) and used for the analysis. | Changes from baseline to week 12 (+/- 7 days). |
| Secondary Outcome - Central retinal sensitivity |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory Outcome - Change in Adenosine Deaminase (ADA) | Inflammatory markers will be evaluated to investigate the potential anti-inflammatory effect of this treatment. | Baseline to week 12 (+/- 7 days) |
| Exploratory Outcome - Change in Artemin (ARTN) |
Inclusion Criteria:
Exclusion Criteria:
Any patient showing a clinically significant improvement between the initial screening and presenting for the first screening/baseline visit may no longer be eligible for the study and will be recorded as a screen failure and will not be entered on to the study.
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| Name | Affiliation | Role |
|---|---|---|
| Noemi Lois | Belfast Health & Social Care Trust and Queen's University Belfast | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Belfast Health & Social Care Trust | Belfast | Co Antrim | BT12 6BA | United Kingdom |
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| ID | Term |
|---|---|
| C576178 | cibinetide |
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Retinal sensitivity will be determined by macular microperimetry in both eyes. |
| Changes from baseline to week 12 (+/- 7 days) |
| Secondary Outcome - Retinal perfusion | Retinal perfusion will be assessed by wide angle fundus fluorescein angiography (FFA). | Changes from baseline to week 12 (+/- 7 days) |
| Secondary Outcome - Tear production | The Schirmer test will be performed to measure tear production. | Changes from baseline to week 12 (+/- 7 days) |
| Secondary Outcome - Patient reported outcome | Patient reported outcomes will be evaluated by means of EQ-5D 5L questionnaires which will be administered to patients at baseline and at week 12 (and at week 16 if applicable). | Changes from baseline to week 12 (+/- 7 days) |
| Secondary Outcome - Change in inflammatory markers | A blood sample will be used to test for ARA 290 antibodies and to complete an exploratory analysis to determine levels of inflammatory markers and carbamylated and glycosylated albumin. | Changes from baseline to week 12 (+/- 7 days) |
| Secondary Outcome - Number of Adverse events | Adverse events | Changes from baseline to week 12 (+/- 7 days) |
| Secondary Outcome -% of participants with ≥ 15 ETDRS letter gain | using Best corrected distance visual acuity | baseline to week 12 |
| Secondary Outcome -% of participants with ≥ 10 ETDRS letter gain | using Best corrected distance visual acuity | baseline to week 12 |
| Secondary Outcome - Patient reported outcomes | Patient reported outcomes will be evaluated by means of NEI VFQ-25 questionnaires which will be administered to patients at baseline and at week 12 (and at week 16 if applicable). | Changes from baseline to week 12 (+/- 7 days) |
| Secondary Outcome - Change in glycosylated albumin | A blood sample will be used to test for ARA 290 antibodies and to complete an exploratory analysis to determine levels of inflammatory markers and carbamylated and glycosylated albumin. | Changes from baseline to week 12 (+/- 7 days) |
| Secondary Outcome - Change in carbamylated albumin | A blood sample will be used to test for ARA 290 antibodies and to complete an exploratory analysis to determine levels of inflammatory markers and carbamylated and glycosylated albumin. | Changes from baseline to week 12 (+/- 7 days) |
Inflammatory markers will be evaluated to investigate the potential anti-inflammatory effect of this treatment.
| Baseline to week 12 (+/- 7 days) |
| Exploratory Outcome - Axin-1 (AXIN1) | Inflammatory markers will be evaluated to investigate the potential anti-inflammatory effect of this treatment. | Baseline to week 12 (+/- 7 days) |
| Exploratory Outcome - Beta-nerve growth factor (BDNF) | Inflammatory markers will be evaluated to investigate the potential anti-inflammatory effect of this treatment. | Baseline to week 12 (+/- 7 days) |
| Exploratory Outcome - Caspase 8 (CASP-8) | Inflammatory markers will be evaluated to investigate the potential anti-inflammatory effect of this treatment. | Baseline to week 12 (+/- 7 days) |
| Exploratory Outcome - C-C motif chemokine 4 (CCL4) | Inflammatory markers will be evaluated to investigate the potential anti-inflammatory effect of this treatment. | Baseline to week 12 (+/- 7 days) |
| Exploratory Outcome - C-C motif chemokine 19 (CCL19) | Inflammatory markers will be evaluated to investigate the potential anti-inflammatory effect of this treatment. | Baseline to week 12 (+/- 7 days) |
| Exploratory Outcome - C-C motif chemokine 20 (CCL20) | Inflammatory markers will be evaluated to investigate the potential anti-inflammatory effect of this treatment. | Baseline to week 12 (+/- 7 days) |
| Exploratory Outcome - C-C motif chemokine 25 (CCL25) | Inflammatory markers will be evaluated to investigate the potential anti-inflammatory effect of this treatment. | Baseline to week 12 (+/- 7 days) |
| Exploratory Outcome - C-C motif chemokine 28 (CCL28) | Inflammatory markers will be evaluated to investigate the potential anti-inflammatory effect of this treatment. | Baseline to week 12 (+/- 7 days) |
| Exploratory Outcome - CD40L receptor (CD40) | Inflammatory markers will be evaluated to investigate the potential anti-inflammatory effect of this treatment. | Baseline to week 12 (+/- 7 days) |
| Exploratory Outcome - CUB domain-containing protein 1 (CDCP1) | Inflammatory markers will be evaluated to investigate the potential anti-inflammatory effect of this treatment. | Baseline to week 12 (+/- 7 days) |
| Exploratory Outcome - C-X-C motif chemokine 1 (CXCL1) | Inflammatory markers will be evaluated to investigate the potential anti-inflammatory effect of this treatment. | Baseline to week 12 (+/- 7 days) |
| Exploratory Outcome - C-X-C motif chemokine 5 (CXCL5) | Inflammatory markers will be evaluated to investigate the potential anti-inflammatory effect of this treatment. | Baseline to week 12 (+/- 7 days) |
| Exploratory Outcome -C-X-C motif chemokine 6 (CXCL6) | Inflammatory markers will be evaluated to investigate the potential anti-inflammatory effect of this treatment. | Baseline to week 12 (+/- 7 days) |
| Exploratory Outcome -C-X-C motif chemokine 9 (CXCL9) | Inflammatory markers will be evaluated to investigate the potential anti-inflammatory effect of this treatment. | Baseline to week 12 (+/- 7 days) |
| Exploratory Outcome -C-X-C motif chemokine 10 (CXCL10) | Inflammatory markers will be evaluated to investigate the potential anti-inflammatory effect of this treatment. | Baseline to week 12 (+/- 7 days) |
| Exploratory Outcome -C-X-C motif chemokine 11 (CXCL11) | Inflammatory markers will be evaluated to investigate the potential anti-inflammatory effect of this treatment. | Baseline to week 12 (+/- 7 days) |
| Exploratory Outcome -Cystatin D (CST5) | Inflammatory markers will be evaluated to investigate the potential anti-inflammatory effect of this treatment. | Baseline to week 12 (+/- 7 days) |
| Exploratory Outcome -Delta and Notch-like epidermal growth factor related recep (DNER) | Inflammatory markers will be evaluated to investigate the potential anti-inflammatory effect of this treatment. | Baseline to week 12 (+/- 7 days) |
| Exploratory Outcome -Eotaxin-1 (CCL11) | Inflammatory markers will be evaluated to investigate the potential anti-inflammatory effect of this treatment. | Baseline to week 12 (+/- 7 days) |
| Exploratory Outcome -karyotic translation initiation factor 4Ebinding protein 1 (4E-BP1) | Inflammatory markers will be evaluated to investigate the potential anti-inflammatory effect of this treatment. | Baseline to week 12 (+/- 7 days) |
| Exploratory Outcome -Fibroblast growth factor 5 (FGF-5) | Inflammatory markers will be evaluated to investigate the potential anti-inflammatory effect of this treatment. | Baseline to week 12 (+/- 7 days) |
| Exploratory Outcome -Fibroblast growth factor 19 (FGF-19) | Inflammatory markers will be evaluated to investigate the potential anti-inflammatory effect of this treatment. | Baseline to week 12 (+/- 7 days) |
| Exploratory Outcome -Fibroblast growth factor 21 (FGF-21) | Inflammatory markers will be evaluated to investigate the potential anti-inflammatory effect of this treatment. | Baseline to week 12 (+/- 7 days) |
| Exploratory Outcome -Fibroblast growth factor 23 (FGF-23) | Inflammatory markers will be evaluated to investigate the potential anti-inflammatory effect of this treatment. | Baseline to week 12 (+/- 7 days) |
| Exploratory Outcome -Fms-related tyrosine kinase 3 ligand (Flt3L) | Inflammatory markers will be evaluated to investigate the potential anti-inflammatory effect of this treatment. | Baseline to week 12 (+/- 7 days) |
| Exploratory Outcome -Fractalkine (CX3CL1) | Inflammatory markers will be evaluated to investigate the potential anti-inflammatory effect of this treatment. | Baseline to week 12 (+/- 7 days) |
| Exploratory Outcome -Glial cell line-derived neurotrophic factor (hGDNF) | Inflammatory markers will be evaluated to investigate the potential anti-inflammatory effect of this treatment. | Baseline to week 12 (+/- 7 days) |
| Exploratory Outcome -Hepatocyte growth factor (HGF) | Inflammatory markers will be evaluated to investigate the potential anti-inflammatory effect of this treatment. | Baseline to week 12 (+/- 7 days) |
| Exploratory Outcome -Interferon gamma (IFN-gamma) | Inflammatory markers will be evaluated to investigate the potential anti-inflammatory effect of this treatment. | Baseline to week 12 (+/- 7 days) |
| Exploratory Outcome -Interleukin-1 alpha (IL-1 alpha) | Inflammatory markers will be evaluated to investigate the potential anti-inflammatory effect of this treatment. | Baseline to week 12 (+/- 7 days) |
| Exploratory Outcome -Interleukin-2 (IL-2) | Inflammatory markers will be evaluated to investigate the potential anti-inflammatory effect of this treatment. | Baseline to week 12 (+/- 7 days) |
| Exploratory Outcome -Interleukin-2 receptor subunit beta (IL-2RB) | Inflammatory markers will be evaluated to investigate the potential anti-inflammatory effect of this treatment. | Baseline to week 12 (+/- 7 days) |
| Exploratory Outcome -Interleukin-4 (IL-4) | Inflammatory markers will be evaluated to investigate the potential anti-inflammatory effect of this treatment. | Baseline to week 12 (+/- 7 days) |
| Exploratory Outcome -Interleukin-5 (IL-5) | Inflammatory markers will be evaluated to investigate the potential anti-inflammatory effect of this treatment. | Baseline to week 12 (+/- 7 days) |
| Exploratory Outcome -Interleukin-6 (IL-6) | Inflammatory markers will be evaluated to investigate the potential anti-inflammatory effect of this treatment. | Baseline to week 12 (+/- 7 days) |
| Exploratory Outcome -Interleukin-7 (IL-7) | Inflammatory markers will be evaluated to investigate the potential anti-inflammatory effect of this treatment. | Baseline to week 12 (+/- 7 days) |
| Exploratory Outcome -Interleukin-8 (IL-8) | Inflammatory markers will be evaluated to investigate the potential anti-inflammatory effect of this treatment. | Baseline to week 12 (+/- 7 days) |
| Exploratory Outcome -Interleukin-10 (IL-10) | Inflammatory markers will be evaluated to investigate the potential anti-inflammatory effect of this treatment. | Baseline to week 12 (+/- 7 days) |
| Exploratory Outcome -Interleukin-10 receptor subunit alpha (IL-10RA) | Inflammatory markers will be evaluated to investigate the potential anti-inflammatory effect of this treatment. | Baseline to week 12 (+/- 7 days) |
| Exploratory Outcome -Interleukin-10 receptor subunit beta (IL-10RB) | Inflammatory markers will be evaluated to investigate the potential anti-inflammatory effect of this treatment. | Baseline to week 12 (+/- 7 days) |
| Exploratory Outcome -Interleukin-12 subunit beta (IL-12B) | Inflammatory markers will be evaluated to investigate the potential anti-inflammatory effect of this treatment. | Baseline to week 12 (+/- 7 days) |
| Exploratory Outcome -Interleukin-13 (IL-13) | Inflammatory markers will be evaluated to investigate the potential anti-inflammatory effect of this treatment. | Baseline to week 12 (+/- 7 days) |
| Exploratory Outcome -interleukin-15 receptor subunit alpha (IL-15RA) | Inflammatory markers will be evaluated to investigate the potential anti-inflammatory effect of this treatment. | Baseline to week 12 (+/- 7 days) |
| Exploratory Outcome -Interleukin-17A (IL-17A) | Inflammatory markers will be evaluated to investigate the potential anti-inflammatory effect of this treatment. | Baseline to week 12 (+/- 7 days) |
| Exploratory Outcome -Interleukin-17C (IL-17C) | Inflammatory markers will be evaluated to investigate the potential anti-inflammatory effect of this treatment. | Baseline to week 12 (+/- 7 days) |
| Exploratory Outcome -Interleukin-20 (IL-20) | Inflammatory markers will be evaluated to investigate the potential anti-inflammatory effect of this treatment. | Baseline to week 12 (+/- 7 days) |
| Exploratory Outcome -Interleukin-20 receptor subunit alpha (IL-20RA) | Inflammatory markers will be evaluated to investigate the potential anti-inflammatory effect of this treatment. | Baseline to week 12 (+/- 7 days) |
| Exploratory Outcome -Interleukin-23 (IL-24) | Inflammatory markers will be evaluated to investigate the potential anti-inflammatory effect of this treatment. | Baseline to week 12 (+/- 7 days) |
| Exploratory Outcome -Interleukin-22 receptor subunit alpha-1 (IL-22 RA1) | Inflammatory markers will be evaluated to investigate the potential anti-inflammatory effect of this treatment. | Baseline to week 12 (+/- 7 days) |
| Exploratory Outcome -Interleukin-33 (IL-33) | Inflammatory markers will be evaluated to investigate the potential anti-inflammatory effect of this treatment. | Baseline to week 12 (+/- 7 days) |
| Exploratory Outcome -Latency-associated peptide transforming growth factor beta 1 (LAP TGF-beta-1) | Inflammatory markers will be evaluated to investigate the potential anti-inflammatory effect of this treatment. | Baseline to week 12 (+/- 7 days) |
| Exploratory Outcome -Leukemia inhibitory factor receptor (LIF-R) | Inflammatory markers will be evaluated to investigate the potential anti-inflammatory effect of this treatment. | Baseline to week 12 (+/- 7 days) |
| Exploratory Outcome -Macrophage colony-stimulating factor 1 (CSF-1) | Inflammatory markers will be evaluated to investigate the potential anti-inflammatory effect of this treatment. | Baseline to week 12 (+/- 7 days) |
| Exploratory Outcome -Macrophage inflammatory protein 1-alpha (MIP1 alpha) | Inflammatory markers will be evaluated to investigate the potential anti-inflammatory effect of this treatment. | Baseline to week 12 (+/- 7 days) |
| Exploratory Outcome -Matrix metalloproteinase-1 (MMP-1) | Inflammatory markers will be evaluated to investigate the potential anti-inflammatory effect of this treatment. | Baseline to week 12 (+/- 7 days) |
| Exploratory Outcome -Matrix metalloproteinase-10 (MMP-10) | Inflammatory markers will be evaluated to investigate the potential anti-inflammatory effect of this treatment. | Baseline to week 12 (+/- 7 days) |
| Exploratory Outcome -Monocyte chemotactic protein 1 (MCP-1) | Inflammatory markers will be evaluated to investigate the potential anti-inflammatory effect of this treatment. | Baseline to week 12 (+/- 7 days) |
| Exploratory Outcome -Monocyte chemotactic protein 2 (MCP-2) | Inflammatory markers will be evaluated to investigate the potential anti-inflammatory effect of this treatment. | Baseline to week 12 (+/- 7 days) |
| Exploratory Outcome -Monocyte chemotactic protein 3 (MCP-3) | Inflammatory markers will be evaluated to investigate the potential anti-inflammatory effect of this treatment. | Baseline to week 12 (+/- 7 days) |
| Exploratory Outcome -Monocyte chemotactic protein 4 (MCP-4) | Inflammatory markers will be evaluated to investigate the potential anti-inflammatory effect of this treatment. | Baseline to week 12 (+/- 7 days) |
| Exploratory Outcome -Natural killer cell receptor 2B4 (CD244) | Inflammatory markers will be evaluated to investigate the potential anti-inflammatory effect of this treatment. | Baseline to week 12 (+/- 7 days) |
| Exploratory Outcome -Neurotrophin-3 (NT-3) | Inflammatory markers will be evaluated to investigate the potential anti-inflammatory effect of this treatment. | Baseline to week 12 (+/- 7 days) |
| Exploratory Outcome -Neurturin (NRTN) | Inflammatory markers will be evaluated to investigate the potential anti-inflammatory effect of this treatment. | Baseline to week 12 (+/- 7 days) |
| Exploratory Outcome -Oncostatin-M (OSM) | Inflammatory markers will be evaluated to investigate the potential anti-inflammatory effect of this treatment. | Baseline to week 12 (+/- 7 days) |
| Exploratory Outcome -Osteoprotegerin (OPG) | Inflammatory markers will be evaluated to investigate the potential anti-inflammatory effect of this treatment. | Baseline to week 12 (+/- 7 days) |
| Exploratory Outcome -Programmed cell death 1 ligand 1 (PD-L1) | Inflammatory markers will be evaluated to investigate the potential anti-inflammatory effect of this treatment. | Baseline to week 12 (+/- 7 days) |
| Exploratory Outcome -Protein S100-A12 (EN-RAGE) | Inflammatory markers will be evaluated to investigate the potential anti-inflammatory effect of this treatment. | Baseline to week 12 (+/- 7 days) |
| Exploratory Outcome -Signaling lymphocytic activation molecule (SLAMF1) | Inflammatory markers will be evaluated to investigate the potential anti-inflammatory effect of this treatment. | Baseline to week 12 (+/- 7 days) |
| Exploratory Outcome -SIR2-like protein 2 (SIRT2) | Inflammatory markers will be evaluated to investigate the potential anti-inflammatory effect of this treatment. | Baseline to week 12 (+/- 7 days) |
| Exploratory Outcome -STAM-binding protein (STAMPB) | Inflammatory markers will be evaluated to investigate the potential anti-inflammatory effect of this treatment. | Baseline to week 12 (+/- 7 days) |
| Exploratory Outcome -Stem cell factor (SCF) | Inflammatory markers will be evaluated to investigate the potential anti-inflammatory effect of this treatment. | Baseline to week 12 (+/- 7 days) |
| Exploratory Outcome -Sulfotransferase 1A1 (ST1A1) | Inflammatory markers will be evaluated to investigate the potential anti-inflammatory effect of this treatment. | Baseline to week 12 (+/- 7 days) |
| Exploratory Outcome -T-cell surface glycoprotein CD5 (CD5) | Inflammatory markers will be evaluated to investigate the potential anti-inflammatory effect of this treatment. | Baseline to week 12 (+/- 7 days) |
| Exploratory Outcome -T cell surface glycoprotein CD6 isoform (CD6) | Inflammatory markers will be evaluated to investigate the potential anti-inflammatory effect of this treatment. | Baseline to week 12 (+/- 7 days) |
| Exploratory Outcome -Thymic stromal lymphopoietin (TSLP) | Inflammatory markers will be evaluated to investigate the potential anti-inflammatory effect of this treatment. | Baseline to week 12 (+/- 7 days) |
| Exploratory Outcome -TNF-beta (TNFB) | Inflammatory markers will be evaluated to investigate the potential anti-inflammatory effect of this treatment. | Baseline to week 12 (+/- 7 days) |
| Exploratory Outcome -TNF-related activation-induced cytokine (TRANCE) | Inflammatory markers will be evaluated to investigate the potential anti-inflammatory effect of this treatment. | Baseline to week 12 (+/- 7 days) |
| Exploratory Outcome -TNF-related apoptosis-inducing ligand (TRAIL) | Inflammatory markers will be evaluated to investigate the potential anti-inflammatory effect of this treatment. | Baseline to week 12 (+/- 7 days) |
| Exploratory Outcome -Transforming growth factor alpha (TGF-alpha) | Inflammatory markers will be evaluated to investigate the potential anti-inflammatory effect of this treatment. | Baseline to week 12 (+/- 7 days) |
| Exploratory Outcome -Tumor necrosis factor (ligand) superfamily, member 12 (TWEAK) | Inflammatory markers will be evaluated to investigate the potential anti-inflammatory effect of this treatment. | Baseline to week 12 (+/- 7 days) |
| Exploratory Outcome -Tumor necrosis factor (TNF) | Inflammatory markers will be evaluated to investigate the potential anti-inflammatory effect of this treatment. | Baseline to week 12 (+/- 7 days) |
| Exploratory Outcome -Tumor necrosis factor ligand superfamily member 14 (TNFSF14) | Inflammatory markers will be evaluated to investigate the potential anti-inflammatory effect of this treatment. | Baseline to week 12 (+/- 7 days) |
| Exploratory Outcome -Tumor necrosis factor ligand superfamily member 9 (TNFSF9) | Inflammatory markers will be evaluated to investigate the potential anti-inflammatory effect of this treatment. | Baseline to week 12 (+/- 7 days) |
| Exploratory Outcome -Urokinase-type plasminogen activator (uPA) | Inflammatory markers will be evaluated to investigate the potential anti-inflammatory effect of this treatment. | Baseline to week 12 (+/- 7 days) |
| Exploratory Outcome -Vascular endothelial growth factor A (VEGF-A) | Inflammatory markers will be evaluated to investigate the potential anti-inflammatory effect of this treatment. | Baseline to week 12 (+/- 7 days) |
| Exploratory Outcome - Carbamylated albumin | Carbamylated albumin will be obtained as an additional measure of renal function and metabolic status. | Baseline to week 12 (+/- 7 days) |
| Exploratory Outcome - Glycosylatedalbumin | Glycosylated albumin will be obtained as a confirmatory marker of glucose control. | Baseline to week 12 (+/- 7 days) |