Compare the Efficacy of VItrectomy Combined With DExamethasone Implant Versus With Aflibercept in DME Patients Diagnosed by Intraoperative OCT (the VIDEO Study): Study Protocol for a Randomized Controlled Trial

PHASE4UnknownINTERVENTIONAL
Enrollment

64

Participants

Timeline

Start Date

October 1, 2023

Primary Completion Date

October 1, 2024

Study Completion Date

April 1, 2025

Conditions
Diabetic Macular EdemaPars Plana VitrectomyDexamethasone Intravitreal ImplantIntraoperative Optical Coherence Tomography
Interventions
DRUG

Ozurdex

Standard 25-gauge pars plana vitrectomy (PPV) will be performed under retrobulbar anaesthesia using high-speed vitrectomy system. Clear all the vitreous hemorrhage and proliferative membrane during PPV operation, panretinal photocoagulation (PRP) should be completed. The vitreous cavity will be filled with balanced salt solution. An injection of Ozurdex will be performed at the end of the surgery.

DRUG

Aflibercept

Standard 25-gauge pars plana vitrectomy (PPV) will be performed under retrobulbar anaesthesia using high-speed vitrectomy system. Clear all the vitreous hemorrhage and proliferative membrane during PPV operation, panretinal photocoagulation (PRP) should be completed. The vitreous cavity will be filled with balanced salt solution. An injection of aflibercept will be performed at the end of the surgery.

Trial Locations (1)

Unknown

RECRUITING

Tianjin medical university eye hosipital, Tianjin

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

AbbVie

INDUSTRY

lead

Tianjin Medical University Eye Hospital

OTHER