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

NCT05990829 | Unknown Phase 4

• 1 other identifier: TianjinMUEHhbj001
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Average change in central foveal thickness (CFT)

  Three-dimensional swept source optical coherence tomography (SS-OCT)

  1, 3, 6 month postoperatively

Secondary Outcomes (2)

• Average change in best corrected visual acuity (BCVA)

  1, 3, 6 month postoperatively

• Number of reinjections

  6 months postoperatively

Study Arms (2)

Ozurdex group

EXPERIMENTAL

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

Aflibercept group

ACTIVE COMPARATOR

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

Interventions

Ozurdex DRUG

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.

Ozurdex group

Aflibercept DRUG

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.

Aflibercept group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tianjin Medical University Eye Hospital: lead
• AbbVie: collaborator

Study Sites (1)

Tianjin medical university eye hosipital

Tianjin, Tianjin Municipality, China

RECRUITING

MeSH Terms

Interventions

Calcium Dobesilate; aflibercept

Intervention Hierarchy (Ancestors)

Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Central Study Contacts

Bojie Hu

CONTACT

bhu07@tmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 6, 2023
• First Posted: August 14, 2023
• Study Start: October 1, 2023
• Primary Completion: October 1, 2024
• Study Completion: April 1, 2025
• Last Updated: March 6, 2024

Record last verified: 2023-08

Locations

CN (1)