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

NCT06300918 | Recruiting

• 1 other identifier: 2024-KY76
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

The Condition of Fundus Neovascularization

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

Injecting anti-VEGF drugs 3 days before operation

EXPERIMENTAL

Injecting Conbercept into vitreous cavity 3 days before performing vitrectomy.

Other: Time

Injecting anti-VEGF drugs 7 days before operation

EXPERIMENTAL

Injecting Conbercept into vitreous cavity 7 days before performing vitrectomy.

Other: Time

Injecting anti-VEGF drugs 14 days before operation

EXPERIMENTAL

Injecting Conbercept into vitreous cavity 14 days before performing vitrectomy.

Other: Time

Interventions

Time OTHER

Time point of injecting anti-VEGF drugs

Injecting anti-VEGF drugs 14 days before operation; Injecting anti-VEGF drugs 3 days before operation; Injecting anti-VEGF drugs 7 days before operation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jie Li: lead

Study Sites (1)

Sichuan Academy of Medical Science Sichuan Provincial Hosptial

Chengdu, Sichuan, 610014, China

RECRUITING

MeSH Terms

Interventions

Time

Intervention Hierarchy (Ancestors)

Physical Phenomena

Central Study Contacts

Jie Li, doctor

CONTACT

+86 139 0809 4675; lijieyk@med.uestc.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 22, 2024
• First Posted: March 8, 2024
• Study Start: March 8, 2024
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: March 19, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: 2025 and forever
• Access Criteria: via https://pan.baidu.com

Locations

CN (1)