Study on Precision Treatment of Diabetic Retinopathy Macular Edema Guided by Real-time OCT During Operation
Primary Purpose
Diabetic Retinopathy
Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Ranibizumab Injection [Lucentis]
Inner limiting membrane stripping
Dexamethasone intravitreal implant
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Retinopathy
Eligibility Criteria
Inclusion Criteria:
- PDR patients with severe vitreous hemorrhage who cannot collect oct images and need vitrectomy
- Type 2 diabetes, aged 18~80 years old
- Good blood sugar control (glycated hemoglobin <8.3%)
- Sign the informed consent form voluntarily, and are willing and able to follow the outpatient visits and research procedures within the time specified in the trial
Exclusion Criteria:
- Exclude severe infections of conjunctiva, cornea, and sclera
- Combined with other retinal vascular diseases such as retinal vein occlusion
- Cardiorenal insufficiency
- Myocardial infarction or stroke occurred within 6 months.
Sites / Locations
- Affiliated Hospital of Nantong UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Anti-VEGF treatment group
Inner limiting membrane stripping group
Glucocorticoid treatment group
Arm Description
Visual acuity and center thickness of the macula
Visual acuity and center thickness of the macula
Visual acuity and center thickness of the macula
Outcomes
Primary Outcome Measures
Review the patient's vision before surgery
Optical Coherence Tomography (OCT) is currently the main examination method for measuring retinal thickness and evaluating DME morphology and fine structure. DME OCT examination has a variety of morphological manifestations and accompanying images, and various manifestations reflect different pathological basis.
Secondary Outcome Measures
Review the patient's vision for one day after surgery
Optical Coherence Tomography (OCT) is currently the main examination method for measuring retinal thickness and evaluating DME morphology and fine structure. DME OCT examination has a variety of morphological manifestations and accompanying images, and various manifestations reflect different pathological basis.
Review the patient's vision for 7 days after surgery
Optical Coherence Tomography (OCT) is currently the main examination method for measuring retinal thickness and evaluating DME morphology and fine structure. DME OCT examination has a variety of morphological manifestations and accompanying images, and various manifestations reflect different pathological basis.
Review the patient's vision for 1 month after surgery
Optical Coherence Tomography (OCT) is currently the main examination method for measuring retinal thickness and evaluating DME morphology and fine structure. DME OCT examination has a variety of morphological manifestations and accompanying images, and various manifestations reflect different pathological basis.
Review the patient's vision for 3 months after surgery
Optical Coherence Tomography (OCT) is currently the main examination method for measuring retinal thickness and evaluating DME morphology and fine structure. DME OCT examination has a variety of morphological manifestations and accompanying images, and various manifestations reflect different pathological basis.
Review the patient's vision for 6 months after surgery
Optical Coherence Tomography (OCT) is currently the main examination method for measuring retinal thickness and evaluating DME morphology and fine structure. DME OCT examination has a variety of morphological manifestations and accompanying images, and various manifestations reflect different pathological basis.
Full Information
NCT ID
NCT05138029
First Posted
September 22, 2021
Last Updated
July 28, 2023
Sponsor
Affiliated Hospital of Nantong University
1. Study Identification
Unique Protocol Identification Number
NCT05138029
Brief Title
Study on Precision Treatment of Diabetic Retinopathy Macular Edema Guided by Real-time OCT During Operation
Official Title
Study on Precision Treatment of Diabetic Retinopathy Macular Edema Guided by Real-time Optical Coherence Tomography During Operation
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 15, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
May 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Affiliated Hospital of Nantong University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
Select Proliferative Proliferative diabetic retinopathy(PDR) patients who are planning to undergo vitrectomy for informed notification. After obtaining informed consent, vitrectomy will be performed. After hemorrhage is removed, the macular shape can be obtained through intraoperative optical coherence tomography (iOCT) real-time scanning. If the central Macular Thickness (CMT) of the patient is ≥250μm, random Enter the Anti-vascular endothelial growth factor (anti-VEGF) treatment group, the internal limiting membrane stripping group and the glucocorticoid treatment group for treatment, and compare the patients' visual acuity (1 day, 7 days, 1 month, 3 months, 6 months) and The thickness of the center of the macula, compare and observe its treatment effect.
Detailed Description
Test method:
Include suitable cases of diabetic retinopathy and macular edema Inclusion criteria: a. PDR patients with severe vitreous hemorrhage who cannot collect oct images and require vitrectomy b. Type 2 diabetes, aged 18~80 years old c. Good blood sugar control (glycated hemoglobin <8.3%) d. Sign the informed consent form voluntarily, and are willing and able to follow the outpatient visits and research procedures within the time specified in the trial Exclusion criteria: a. Exclude severe infections of conjunctiva, cornea, and sclera b. Combined with other retinal vascular diseases such as retinal vein occlusion c. Cardiorenal insufficiency d. Myocardial infarction or stroke occurred within 6 months ②Intraoperative real-time operation All patients underwent 25Gauge(25G) transplanter three-channel vitrectomy to remove cloudy vitreous or vitreous hemorrhage and posterior vitreous cortex. Through intraoperative oct, the macular area was observed in real time and the central macular thickness was measured. If central macular thickness (CMT) ≥ 250 μm, anti-VEGF, glucocorticoid, or internal limiting membrane peeling was randomly selected to treat macular edema.
Re-examine the effect of surgery after operation The visual acuity and the thickness of the center of the macula were reviewed at 1 day, 7 days, 1 month, 3 months, and 6 months after the operation to compare the effect of the operation, and observe the cornea, anterior chamber, vitreous cavity, and intraocular pressure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Retinopathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Anti-VEGF treatment group
Arm Type
Experimental
Arm Description
Visual acuity and center thickness of the macula
Arm Title
Inner limiting membrane stripping group
Arm Type
Experimental
Arm Description
Visual acuity and center thickness of the macula
Arm Title
Glucocorticoid treatment group
Arm Type
Experimental
Arm Description
Visual acuity and center thickness of the macula
Intervention Type
Drug
Intervention Name(s)
Ranibizumab Injection [Lucentis]
Other Intervention Name(s)
Lucentis
Intervention Description
The visual acuity and the thickness of the center of the macula were reviewed at 1 day, 7 days, 1 month, 3 months, and 6 months after the operation to compare the effect of the operation, and observe the cornea, anterior chamber, vitreous cavity, and intraocular pressure.
Intervention Type
Procedure
Intervention Name(s)
Inner limiting membrane stripping
Intervention Description
The visual acuity and the thickness of the center of the macula were reviewed at 1 day, 7 days, 1 month, 3 months, and 6 months after the operation to compare the effect of the operation, and observe the cornea, anterior chamber, vitreous cavity, and intraocular pressure.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone intravitreal implant
Other Intervention Name(s)
Dexamethasone Implants
Intervention Description
The visual acuity and the thickness of the center of the macula were reviewed at 1 day, 7 days, 1 month, 3 months, and 6 months after the operation to compare the effect of the operation, and observe the cornea, anterior chamber, vitreous cavity, and intraocular pressure.
Primary Outcome Measure Information:
Title
Review the patient's vision before surgery
Description
Optical Coherence Tomography (OCT) is currently the main examination method for measuring retinal thickness and evaluating DME morphology and fine structure. DME OCT examination has a variety of morphological manifestations and accompanying images, and various manifestations reflect different pathological basis.
Time Frame
The day before the patient's surgery
Secondary Outcome Measure Information:
Title
Review the patient's vision for one day after surgery
Description
Optical Coherence Tomography (OCT) is currently the main examination method for measuring retinal thickness and evaluating DME morphology and fine structure. DME OCT examination has a variety of morphological manifestations and accompanying images, and various manifestations reflect different pathological basis.
Time Frame
The patient's first day after surgery
Title
Review the patient's vision for 7 days after surgery
Description
Optical Coherence Tomography (OCT) is currently the main examination method for measuring retinal thickness and evaluating DME morphology and fine structure. DME OCT examination has a variety of morphological manifestations and accompanying images, and various manifestations reflect different pathological basis.
Time Frame
1st week after surgery
Title
Review the patient's vision for 1 month after surgery
Description
Optical Coherence Tomography (OCT) is currently the main examination method for measuring retinal thickness and evaluating DME morphology and fine structure. DME OCT examination has a variety of morphological manifestations and accompanying images, and various manifestations reflect different pathological basis.
Time Frame
4th week after surgery
Title
Review the patient's vision for 3 months after surgery
Description
Optical Coherence Tomography (OCT) is currently the main examination method for measuring retinal thickness and evaluating DME morphology and fine structure. DME OCT examination has a variety of morphological manifestations and accompanying images, and various manifestations reflect different pathological basis.
Time Frame
12th week after surgery
Title
Review the patient's vision for 6 months after surgery
Description
Optical Coherence Tomography (OCT) is currently the main examination method for measuring retinal thickness and evaluating DME morphology and fine structure. DME OCT examination has a variety of morphological manifestations and accompanying images, and various manifestations reflect different pathological basis.
Time Frame
24th week after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
PDR patients with severe vitreous hemorrhage who cannot collect oct images and need vitrectomy
Type 2 diabetes, aged 18~80 years old
Good blood sugar control (glycated hemoglobin <8.3%)
Sign the informed consent form voluntarily, and are willing and able to follow the outpatient visits and research procedures within the time specified in the trial
Exclusion Criteria:
Exclude severe infections of conjunctiva, cornea, and sclera
Combined with other retinal vascular diseases such as retinal vein occlusion
Cardiorenal insufficiency
Myocardial infarction or stroke occurred within 6 months.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rongrong Zhu, Master
Phone
13809089545
Email
zrreye@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zhuojun Xie, Bachelor
Phone
19502558036
Email
2305908442@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rongrong Zhu, master
Organizational Affiliation
Affiliated Hospital of Nantong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Affiliated Hospital of Nantong University
City
Nantong
State/Province
Jiangsu
ZIP/Postal Code
226001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rongrong Zhu, Master
Phone
13809089545
Email
zrreye@126.com
First Name & Middle Initial & Last Name & Degree
Jian Zhu, Bachelor
Phone
18860975286
Email
1321094354@qq.com
First Name & Middle Initial & Last Name & Degree
Rongrong Zhu, Master
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study on Precision Treatment of Diabetic Retinopathy Macular Edema Guided by Real-time OCT During Operation
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