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

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetic Macular Edema; Pars Plana Vitrectomy; Dexamethasone Intravitreal Implant; Intraoperative Optical Coherence Tomography
• Intervention / Treatment: Drug: Ozurdex; Drug: Aflibercept

• Study Type: Interventional
• Enrollment (Estimated): 64
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Bojie Hu; Email: bhu07@tmu.edu.cn

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China
      • Recruiting
      • Tianjin medical university eye hosipital
      • Contact: Bojie Hu; Phone Number: 13612130943; Email: bhu07@tmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• ≥18 years of age;
• Patients and their families fully understand the research and must sign an informed consent form;
• Patients have a history of diabetes and were diagnosed with PDR by ophthalmic examination;
• Haemoglobin A1c (HbA1c) levels of <10% within 3 months;
• No contraindication of vitrectomy;
• Pseudophakia or this operation is combined with phacoemulsification and lens implantation;
• Diagnosed with DME by intraoperative optical coherence tomography during vitrectomy

Exclusion Criteria:

• The follow-up period is less than 6 months;
• Patients need gas or silicon oil tamponade;
• Patients with rubeosis iridis, neovascular glaucoma and endophthalmitis;
• Patients with other intraocular surgeries (except cataract surgery with no ruptured posterior lens capsule);
• Patients with other retinal diseases (i.e., age-related macular degeneration, retinal vein occlusion);
• Patients received intravitreal Ozurdex three months prior to screening or anti-VEGF injection one month prior to screening;
• Patients with uncontrolled systemic disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ozurdex group; 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 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: 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.
Active Comparator: Aflibercept group; 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 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average change in central foveal thickness (CFT)	Three-dimensional swept source optical coherence tomography (SS-OCT)	1, 3, 6 month postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average change in best corrected visual acuity (BCVA)	Early Treatment Diabetic Retinopathy Study (ETDRS) Alphabet Chart	1, 3, 6 month postoperatively
Number of reinjections	Each participant will receive pro re nata therapy, with regular monitoring for 6 months, at least 3 months apart for the study group and 1 month apart for the control group. Further treatment will be performed if the following criteria are met: (1) existence of recent or persisting cystoid retinal lesions; (2) a decrease of no less than 5 Early Treatment Diabetic Retinopathy Study (ETDRS) letters in BCVA; and (3) an increase of 50 m or more in central foveal thickness (CFT) compared with the best value previously achieved.	6 months postoperatively

Collaborators and Investigators

• Sponsor: Tianjin Medical University Eye Hospital
• Collaborators: Abbvie Pharmaceutical Trading (Shanghai) Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: August 6, 2023
• First Submitted That Met QC Criteria: August 6, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Estimated): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Macular Edema; Physiological Effects of Drugs; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Aflibercept
• Other Study ID Numbers: TianjinMUEHhbj001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No