A Clinical Trial to Evaluate the Time Point of Anti-VEGF Pretreatment of PDR Based on Intraoperative FFA
- Conditions
- The Condition of Fundus Neovascularization
- Interventions
- Other: Time
- Registration Number
- NCT06300918
- Lead Sponsor
- Jie Li
- Brief Summary
The goal of this prospective randomized controlled study is to compare the therapeutic effect of injecting anti-VEGF drugs before surgery for patients with proliferative diabetic retinopathy at different time points. At present, studies have confirmed that anti-VEGF drugs are effective in inhibiting fundus neovascularization in proliferative diabetic retinopathy. The main question it aims to answer is which time point is better to injecting anti-VEGF drugs before surgery for patients with proliferative diabetic retinopathy.
Participants will be randomly divided into three groups. And time points of injecting anti-VEGF drugs before surgery for each group will be 3 days, 7 days, 14 days. And we have a new technology that can have fluorescein fundus angiography during operation, so it can reflect the condition of fundus neovascularization immediately and precisely. In that case, we can compare the Inhibitory effect of anti-VEGF drugs on fundus neovascularization at different time points.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Injecting anti-VEGF drugs 14 days before operation Time Injecting Conbercept into vitreous cavity 14 days before performing vitrectomy. Injecting anti-VEGF drugs 3 days before operation Time Injecting Conbercept into vitreous cavity 3 days before performing vitrectomy. Injecting anti-VEGF drugs 7 days before operation Time Injecting Conbercept into vitreous cavity 7 days before performing vitrectomy.
- Primary Outcome Measures
Name Time Method The number of fundus neovascularization seen in FFA. Observed during operation Fundus neovascularization
The area of fundus neovascularization seen in FFA (using PD size as measurement). Observed during operation Fundus neovascularization
The intensity of neovascularization fluorescein leakage Observed during operation 2- and 5-minute images were taken to assess the intensity of neovascularization fluorescein leakage through FFA.Fluorescein leakage intensity classification and leakage score (judged by postoperative video or jigsaw puzzle) : no leakage is 0; The suspected leakage was level 1. It is clear that the expansion range of leakage point is less than 1PD, which is grade 2. It is clear that leakage greater than or equal to 1PD is grade 3; Leakage integral is the sum of leakage number x leakage strength classification.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Sichuan Academy of Medical Science Sichuan Provincial Hosptial
🇨🇳Chendu, Sichuan, China