drugset / Trial / NCT05138029

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

NCT05138029

Phase 3 Unknown 60 enrolled Affiliated Hospital of Nantong University
RandomizedCrossoverDouble-blindTreatment

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.

Timeline

Start
2021-11-15
Primary completion
2023-12
Completion
2024-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexamethasone Small molecule Intravitreal
Subject Ranibizumab Monoclonal antibody Intravitreal

Indications