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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

Primary Purpose

Diabetic Macular Edema, Pars Plana Vitrectomy, Dexamethasone Intravitreal Implant

Status
Not yet recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Ozurdex
Aflibercept
Sponsored by
Tianjin Medical University Eye Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Macular Edema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tianjin medical university eye hosipital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ozurdex group

Aflibercept group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Average change in central foveal thickness (CFT)
Three-dimensional swept source optical coherence tomography (SS-OCT)

Secondary Outcome Measures

Average change in best corrected visual acuity (BCVA)
Early Treatment Diabetic Retinopathy Study (ETDRS) Alphabet Chart
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.

Full Information

First Posted
August 6, 2023
Last Updated
August 6, 2023
Sponsor
Tianjin Medical University Eye Hospital
Collaborators
Abbvie Pharmaceutical Trading (Shanghai) Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05990829
Brief Title
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
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
October 1, 2024 (Anticipated)
Study Completion Date
April 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tianjin Medical University Eye Hospital
Collaborators
Abbvie Pharmaceutical Trading (Shanghai) Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema, Pars Plana Vitrectomy, Dexamethasone Intravitreal Implant, Intraoperative Optical Coherence Tomography

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ozurdex group
Arm Type
Experimental
Arm Description
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.
Arm Title
Aflibercept group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ozurdex
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Aflibercept
Intervention Description
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.
Primary Outcome Measure Information:
Title
Average change in central foveal thickness (CFT)
Description
Three-dimensional swept source optical coherence tomography (SS-OCT)
Time Frame
1, 3, 6 month postoperatively
Secondary Outcome Measure Information:
Title
Average change in best corrected visual acuity (BCVA)
Description
Early Treatment Diabetic Retinopathy Study (ETDRS) Alphabet Chart
Time Frame
1, 3, 6 month postoperatively
Title
Number of reinjections
Description
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.
Time Frame
6 months postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bojie Hu
Email
bhu07@tmu.edu.cn
Facility Information:
Facility Name
Tianjin medical university eye hosipital
City
Tianjin
State/Province
Tianjin
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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