A Clinical Trial to Evaluate the Time Point of Anti-VEGF Pretreatment of PDR Based on Intraoperative FFA

Launched by JIE LI · Mar 7, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the best timing for injecting a medication called anti-VEGF before surgery in patients with a condition called proliferative diabetic retinopathy (PDR), which involves the growth of abnormal blood vessels in the eye. Researchers want to find out whether giving this injection three, seven, or fourteen days before surgery works best to help reduce these abnormal blood vessels. They will use a special imaging technique during the surgery to see how well the treatment is working.

To participate in this trial, you must be at least 18 years old and have been diagnosed with PDR related to type 1 or type 2 diabetes. You should also have certain blood sugar levels and be experiencing specific eye problems, like persistent bleeding in the eye. During the trial, you will be randomly placed into one of the three groups based on when you will receive the injection before your surgery. This study is currently looking for participants, and it aims to improve the way we treat PDR, potentially helping many people with this condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • PDR is diagnosed in people 18 years of age or older with type 1 or type 2 diabetes，
• • Hemoglobin A1c (HbA1c) ≤10%
• • Persistent vitreous hemorrhage for more than one month or recurrent vitreous hemorrhage (within six months)
• • Did not undergo retintis photocoagulation (PRP)
• • Vitreous hemorrhage disease course within six months
• Exclusion Criteria:
• • Patients who have had previous vitreoretinal surgery
• • Intravitreal drug injection within 3 months
• • Eye diseases other than PDR that may hinder vision improvement, such as optic atrophy or macular hole
• • Thromboembolic events (including cerebrovascular or myocardial infarction) or clotting system disorders or receiving anticoagulation or antiplatelet therapy
• • B-ultrasound or indirect fundus microscopy showing retina detachment (pull or hole origin)
• • Vitrectomy, FFA contraindicated patients, patients with severe abnormality of cardiopulmonary, liver and kidney function