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

NCT ID: NCT06300918

Last Updated: 2024-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-08

Study Completion Date

2025-08-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

The Condition of Fundus Neovascularization

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Injecting anti-VEGF drugs 3 days before operation

Injecting Conbercept into vitreous cavity 3 days before performing vitrectomy.

Group Type EXPERIMENTAL

Time

Intervention Type OTHER

Time point of injecting anti-VEGF drugs

Injecting anti-VEGF drugs 7 days before operation

Injecting Conbercept into vitreous cavity 7 days before performing vitrectomy.

Group Type EXPERIMENTAL

Time

Intervention Type OTHER

Time point of injecting anti-VEGF drugs

Injecting anti-VEGF drugs 14 days before operation

Injecting Conbercept into vitreous cavity 14 days before performing vitrectomy.

Group Type EXPERIMENTAL

Time

Intervention Type OTHER

Time point of injecting anti-VEGF drugs

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Time

Time point of injecting anti-VEGF drugs

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Jie Li

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jie Li

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sichuan Academy of Medical Science Sichuan Provincial Hosptial

Chengdu, Sichuan, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Jie Li, doctor

Role: CONTACT

+86 139 0809 4675

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Jie Li, doctor

Role: primary

+86 13908094675

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2024-KY76

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

PRP vs PRP+IVC for Severe nPDR
NCT03863535 UNKNOWN NA
Intravitreal Conbercept After Vitrectomy
NCT03426540 COMPLETED EARLY_PHASE1