Study on Precision Treatment of Diabetic Retinopathy Macular Edema Guided by Real-time OCT During Operation

Study on Precision Treatment of Diabetic Retinopathy Macular Edema Guided by Real-time Optical Coherence Tomography During Operation

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetic Retinopathy
• Intervention / Treatment: Drug: Ranibizumab Injection [Lucentis]; Procedure: Inner limiting membrane stripping; Drug: Dexamethasone intravitreal implant

Detailed Description

1. 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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Rongrong Zhu, Master; Phone Number: 13809089545; Email: zrreye@126.com
• Study Contact Backup: Name: Zhuojun Xie, Bachelor; Phone Number: 19502558036; Email: 2305908442@qq.com

Study Locations

• China
  • Jiangsu
    • Nantong, Jiangsu, China, 226001
      • Recruiting
      • Affiliated Hospital of Nantong University
      • Contact: Rongrong Zhu, Master; Phone Number: 13809089545; Email: zrreye@126.com
      • Contact: Jian Zhu, Bachelor; Phone Number: 18860975286; Email: 1321094354@qq.com
      • Principal Investigator: Rongrong Zhu, Master

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Anti-VEGF treatment group; Visual acuity and center thickness of the macula	Drug: Ranibizumab Injection [Lucentis]; 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.; Other Names: Lucentis
Experimental: Inner limiting membrane stripping group; Visual acuity and center thickness of the macula	Procedure: Inner limiting membrane stripping; 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.
Experimental: Glucocorticoid treatment group; Visual acuity and center thickness of the macula	Drug: Dexamethasone intravitreal implant; 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.; Other Names: Dexamethasone Implants

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	The day before the patient's surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	The patient's first day after surgery
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.	1st week after surgery
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.	4th week after surgery
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.	12th week after surgery
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.	24th week after surgery

Collaborators and Investigators

• Sponsor: Affiliated Hospital of Nantong University
• Investigators: Principal Investigator: Rongrong Zhu, master, Affiliated Hospital of Nantong University

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2021
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: September 22, 2021
• First Submitted That Met QC Criteria: November 28, 2021
• First Posted (Actual): November 30, 2021

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 28, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Endocrine System Diseases; Diabetic Angiopathies; Diabetes Complications; Diabetes Mellitus; Retinal Degeneration; Macular Degeneration; Retinal Diseases; Diabetic Retinopathy; Macular Edema; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Protease Inhibitors; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Dexamethasone; Dexamethasone acetate; BB 1101; Ranibizumab
• Other Study ID Numbers: MSZ20180

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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