NCT05990829

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: Tianjin Medical University Eye Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Diabetic macular edema (DME) is the main cause of severe vision loss in diabetic retinopathy. Intravitreal injection of anti-vascular endothelial growth factor (VEGF) and Ozurdex are two safe and effective ways to treat DME. Pars plana vitrectomy is mainly suitable for the treatment of unabsorbed vitreous hemorrhage (VH) and tractional retinal detachment caused by proliferative diabetic retinopathy (PDR). Intraoperative optical coherence tomography (OCT), a diagnostic device, can be used to evaluate the potential condition of the retina. Many patients with PDR have unclear refractive stroma due to VH and other reasons, so preoperative OCT cannot give a clear diagnosis, so the use of intraoperative OCT can judge whether the patients are complicated with DME and give corresponding treatment. The purpose of this study is to explore the prognosis of patients with DME diagnosed by OCT during PPV and treated with PPV combined with aflibercept or PPV combined with Ozurdex, and to observe and compare the postoperative anatomical results, functional results, times of reinjections and the occurrence of adverse events between the two groups, in order to provide accurate treatment for patients, reduce the frequency of postoperative vitreous injection and lighten the burden of patients.

Conditions

• Diabetic Macular Edema
• Pars Plana Vitrectomy
• Dexamethasone Intravitreal Implant
• Intraoperative Optical Coherence Tomography

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-10-01
• Primary completion: 2024-10-01
• Completion: 2025-04-01
• First posted: 2023-08-14
• Last updated: 2024-03-06

Locations

1 site across 1 country: China