Ignite Creation Date:
2024-05-06 @ 12:32 PM
Last Modification Date:
2024-10-26 @ 1:00 PM
Study NCT ID:
NCT03780361
Status:
COMPLETED
Last Update Posted:
2024-05-29
First Post:
2018-12-17
Brief Title:
Changes in Inflammatory Biomarkers Including Soluble CD14 and Hyperreflective Foci in DME Patients Treated With Aflibercept FORESIGHT
Sponsor:
Hyewon Chung
Organization:
Konkuk University Medical Center
Study Overview
Official Title:
Changes in Inflammatory Biomarkers Including Soluble CD14 and Hyperreflective Foci in Diabetic Macular Edema Patients Treated With Aflibercept FORESIGHT
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
Recruiting
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FORESIGHT
Brief Summary:
This study evaluates the effect of aflibercept on the change of cytokines incluing sCD14 MCP-1 IL-6 and ICAM-1 in the aqueous humor of DME patients Additionally changes of visual acuity ETDRS optical coherence tomography parameters including hyperreflective foci and thickness of macula are also investigated
Detailed Description:
Intraocular steroid agents have been shown to decrease inflammatory cytokines in diabetic macular edema DME patients and thus have roles in the treatment of these patients However I believe that anti-VEGF could effectively decrease intraocular inflammatory responses in these patients with much fewer side effects than intraocular steroid agents
Since soluble CD14 sCD14 is the known marker of inflammatory cells including microglia increased or decreased retinal inflammation accompanied by DME could be monitored using sCD14 in patients with DME Recently I published an article regarding the strong association of increased sCD14 in the aqueous humor AH from DME patients especially in increased inner retinal edema as well as increased hyper reflective foci HF in optical coherence tomography OCT This associated changes of sCD14 levels and HF in the retina suggested that the HF might represent the activated microglia in DME I also showed that the intravitreal bevacizumab injection resulted in a reduction of sCD14 in the AH and HF in OCT However that study was retrospective and I could not have many patients follow-up data after bevacizumab treatments and thus was not able to get conclusive results regarding decreased retinal inflammation after anti-VEGF Therefore I believe that a well-desinged prospective study is needed to clarify whether retinal inflammation is ameliorated after anti-VEGF treatment Moreover I believe that aflibercept is more appropriate and better drug than bevacizumab to investigate the changes in the cytokine levels along with the improvement of inflammatory milieu in DME due to the following reasons First recent DRCRnet Protocol-T reported the superior clinical outome of aflibercept compared to bevacizumab on DME Second aflibercept has significantly higher binding affinity to VEGF-A compared to ranibizumab or bevacizumab Third aflibercept also binds to VEGF-B and placental growth factor PlGF unlike ranibizumab or bevacizumab PlGF-VEGFR1 pathway contributes to inflammation by triggering production of proinflammatory cytokines
Thus I would like to investigate the efficacy of aflibercept for reducing inflammation in DME Therapeutic effects of aflibercept on reduction of DME in the context of amelioration of inflammation will be proved using sCD14 and HF as surrogate markers in this proposed study Besides sCD14 tracking the cytokines including MCP-1 IL-6 and ICAM-1 in the AH in a well-controlled prospective setting of aflibercept treatments will enhance our understanding regarding the role of inflammation on DME and the importance of aflibercept for decreasing ocular inflammation in DME patients
Since soluble CD14 sCD14 is the known marker of inflammatory cells including microglia increased or decreased retinal inflammation accompanied by DME could be monitored using sCD14 in patients with DME Recently I published an article regarding the strong association of increased sCD14 in the aqueous humor AH from DME patients especially in increased inner retinal edema as well as increased hyper reflective foci HF in optical coherence tomography OCT This associated changes of sCD14 levels and HF in the retina suggested that the HF might represent the activated microglia in DME I also showed that the intravitreal bevacizumab injection resulted in a reduction of sCD14 in the AH and HF in OCT However that study was retrospective and I could not have many patients follow-up data after bevacizumab treatments and thus was not able to get conclusive results regarding decreased retinal inflammation after anti-VEGF Therefore I believe that a well-desinged prospective study is needed to clarify whether retinal inflammation is ameliorated after anti-VEGF treatment Moreover I believe that aflibercept is more appropriate and better drug than bevacizumab to investigate the changes in the cytokine levels along with the improvement of inflammatory milieu in DME due to the following reasons First recent DRCRnet Protocol-T reported the superior clinical outome of aflibercept compared to bevacizumab on DME Second aflibercept has significantly higher binding affinity to VEGF-A compared to ranibizumab or bevacizumab Third aflibercept also binds to VEGF-B and placental growth factor PlGF unlike ranibizumab or bevacizumab PlGF-VEGFR1 pathway contributes to inflammation by triggering production of proinflammatory cytokines
Thus I would like to investigate the efficacy of aflibercept for reducing inflammation in DME Therapeutic effects of aflibercept on reduction of DME in the context of amelioration of inflammation will be proved using sCD14 and HF as surrogate markers in this proposed study Besides sCD14 tracking the cytokines including MCP-1 IL-6 and ICAM-1 in the AH in a well-controlled prospective setting of aflibercept treatments will enhance our understanding regarding the role of inflammation on DME and the importance of aflibercept for decreasing ocular inflammation in DME patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None