Ignite Creation Date:
2024-05-06 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05728476
Status:
RECRUITING
Last Update Posted:
2024-03-06
First Post:
2023-02-02
Brief Title:
Microinvasive Pars Plana Vitrectomy Combined ILM Peeling Versus Anti-VEGF Intravitreal Injection for Treatment-naïve Diabetic Macular Edema
Sponsor:
Tianjin Medical University Eye Hospital
Organization:
Tianjin Medical University Eye Hospital
Study Overview
Official Title:
Microinvasive Pars Plana Vitrectomy Combined ILM Peeling Versus Anti-VEGF Intravitreal Injection for Treatment-naïve Diabetic Macular Edema
Status:
RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
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 macular edema DME is the main cause of vision loss in patients with diabetes At present anti-vascular endothelial growth factor VEGF intravitreal injection is the first-line therapy for DME nevertheless some patients do not respond well to anti-VEGF agents and often require multiple injections which increases the psychological and economic burden of patients Microinvasive pars plana vitrectomy PPV has been proven to be safe and effective for refractory DME However there are few studies on treatment-naïve DME The purpose of this study is to explore whether early PPV combined with internal limiting membrane ILM peeling can reduce the treatment burden of DME patients prevent vision loss and maintain long-term stabilization of diabetic retinopathy
Detailed Description:
None
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