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Clinical trial

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

ID
Name
MSZ20180
Description
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.
Trial arms
Trial start
2021-11-15
Estimated PCD
2023-12-01
Trial end
2024-05-01
Status
Recruiting
Phase
Early phase I
Treatment
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.
Arms:
Anti-VEGF treatment group
Other names:
Lucentis
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.
Arms:
Inner limiting membrane stripping group
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.
Arms:
Glucocorticoid treatment group
Other names:
Dexamethasone Implants
Size
60
Primary endpoint
Review the patient's vision before surgery
The day before the patient's surgery
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}
Updated at
2023-08-01

1 organization

2 products

1 indication

Organization
Affiliated Hospital of Nantong University
Product
Ranibizumab
Indication
Diabetic Retinopathy
Product
Dexamethasone