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

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ClinicalTrials.gov Identifier: NCT05138029
Recruitment Status : Recruiting
First Posted : November 30, 2021
Last Update Posted : March 8, 2022
Sponsor:
Information provided by (Responsible Party):
Affiliated Hospital of Nantong University

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.

Condition or disease Intervention/treatment Phase
Diabetic Retinopathy Drug: Ranibizumab Injection [Lucentis] Procedure: Inner limiting membrane stripping Drug: Dexamethasone intravitreal implant Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Study on Precision Treatment of Diabetic Retinopathy Macular Edema Guided by Real-time Optical Coherence Tomography During Operation
Actual Study Start Date : November 15, 2021
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Dexamethasone Implants




Primary Outcome Measures :
  1. Review the patient's vision before surgery [ Time Frame: The day before the patient's 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 :
  1. Review the patient's vision for one day after surgery [ Time Frame: The patient's first 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.

  2. Review the patient's vision for 7 days after surgery [ Time Frame: 1st week 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.

  3. Review the patient's vision for 1 month after surgery [ Time Frame: 4th week 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.

  4. Review the patient's vision for 3 months after surgery [ Time Frame: 12th week 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.

  5. Review the patient's vision for 6 months after surgery [ Time Frame: 24th week 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05138029


Contacts
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Contact: Rongrong Zhu, Master 13809089545 zrreye@126.com
Contact: Zhuojun Xie, Bachelor 19502558036 2305908442@qq.com

Locations
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China, Jiangsu
Affiliated Hospital of Nantong University Recruiting
Nantong, Jiangsu, China, 226001
Contact: Rongrong Zhu, Master    13809089545    zrreye@126.com   
Contact: Jian Zhu, Bachelor    18860975286    1321094354@qq.com   
Principal Investigator: Rongrong Zhu, Master         
Sponsors and Collaborators
Affiliated Hospital of Nantong University
Investigators
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Principal Investigator: Rongrong Zhu, master Affiliated Hospital of Nantong University
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Responsible Party: Affiliated Hospital of Nantong University
ClinicalTrials.gov Identifier: NCT05138029    
Other Study ID Numbers: MSZ20180
First Posted: November 30, 2021    Key Record Dates
Last Update Posted: March 8, 2022
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Macular Edema
Retinal Diseases
Diabetic Retinopathy
Macular Degeneration
Retinal Degeneration
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Dexamethasone
Dexamethasone acetate
Ranibizumab
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action