Ignite Creation Date:
2024-05-06 @ 5:44 PM
Last Modification Date:
2024-10-26 @ 2:34 PM
Study NCT ID:
NCT05415826
Status:
UNKNOWN
Last Update Posted:
2022-06-13
First Post:
2022-06-08
Brief Title:
Ozurdex in Reducing PVR After Vitreotomy in PDR
Sponsor:
Peking University Peoples Hospital
Organization:
Peking University Peoples Hospital
Study Overview
Official Title:
Slow-Release Dexamethasone in Reducing Proliferative Vitreoretinopathy After Vitreotomy in Proliferative Diabetic Retinopathy
Status:
UNKNOWN
Status Verified Date:
2022-06
Last Known Status:
NOT_YET_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:
None
Brief Summary:
Diabetic retinopathy is a significant source of visual morbidity in the adult population Complications of diabetic retinopathy include ischemic maculopathy macular edema and sequelae of fibrovascular proliferation such as vitreous hemorrhage VH tractional retinal detachment TRD and neovascular glaucomaPars plana vitrectomy PPV is traditionally performed for nonclearing VH significant fibrovascular proliferation refractive macular edema andor TRD particularly if macula-involving However the pathogenesis is complex and multifactorial Pro-infammatory cytokines and chemokines signifcantly contribute to the disease development and promote ischemic changes in the retina Therefore there is a potential role for intravitreal steroids in disease modifcation
Detailed Description:
Diabetic retinopathy is a significant source of visual morbidity in the adult population Complications of diabetic retinopathy include ischemic maculopathy macular edema and sequelae of fibrovascular proliferation such as vitreous hemorrhage VH tractional retinal detachment TRD and neovascular glaucomaPars plana vitrectomy PPV is traditionally performed for nonclearing VH significant fibrovascular proliferation refractive macular edema andor TRD particularly if macula-involving However the pathogenesis is complex and multifactorial Pro-infammatory cytokines and chemokines signifcantly contribute to the disease development and promote ischemic changes in the retina Therefore there is a potential role for intravitreal steroids in disease modifcation Corticosteroids reduce not only leukostasis and infammatory cytokine production but also VEGF expression Experimentally corticosteroids potentially can influence both the inflammatory and the proliferative components of the PVR process via a variety of modes of administration without evidence of demonstrable retinal toxicity So this study is carried out for the purpose of investigating the efficacy of slow-release dexamethasone implant in proliferative vitreoretinopathy of postoperative proliferative diabetic retinopathy
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