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

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

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.

Study Overview

• Status: Recruiting
• Conditions: The Condition of Fundus Neovascularization
• Intervention / Treatment: Other: Time

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jie Li, doctor; Phone Number: +86 139 0809 4675; Email: lijieyk@med.uestc.edu.cn

Study Locations

• China
  • Sichuan
    • Chendu, Sichuan, China, 610014
      • Recruiting
      • Sichuan Academy of Medical Science Sichuan Provincial Hosptial
      • Contact: Jie Li, doctor; Phone Number: +86 13908094675; Email: lijieyk@med.uestc.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Injecting anti-VEGF drugs 3 days before operation; Injecting Conbercept into vitreous cavity 3 days before performing vitrectomy.	Other: Time; Time point of injecting anti-VEGF drugs
Experimental: Injecting anti-VEGF drugs 7 days before operation; Injecting Conbercept into vitreous cavity 7 days before performing vitrectomy.	Other: Time; Time point of injecting anti-VEGF drugs
Experimental: Injecting anti-VEGF drugs 14 days before operation; Injecting Conbercept into vitreous cavity 14 days before performing vitrectomy.	Other: Time; Time point of injecting anti-VEGF drugs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of fundus neovascularization seen in FFA.	Fundus neovascularization	Observed during operation
The area of fundus neovascularization seen in FFA (using PD size as measurement).	Fundus neovascularization	Observed during operation
The intensity of neovascularization fluorescein leakage	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.	Observed during operation

Collaborators and Investigators

• Sponsor: Jie Li

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2024
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: February 22, 2024
• First Submitted That Met QC Criteria: March 7, 2024
• First Posted (Actual): March 8, 2024

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 17, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Metaplasia; Neovascularization, Pathologic
• Other Study ID Numbers: 2024-KY76

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 2030, via https://pan.baidu.com
• IPD Sharing Time Frame: 2025 and forever
• IPD Sharing Access Criteria: via https://pan.baidu.com
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No