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

• Status: Not yet recruiting
• Trial end date: 2023-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Affiliated Hospital of Nantong University
• Treatments: BB 1101; Dexamethasone; Dexamethasone acetate; Ranibizumab

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.