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
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2024-03-08
2025-08-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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Injecting anti-VEGF drugs 3 days before operation
Injecting Conbercept into vitreous cavity 3 days before performing vitrectomy.
Time
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.
Time
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.
Time
Time point of injecting anti-VEGF drugs
Interventions
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Time
Time point of injecting anti-VEGF drugs
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Jie Li
OTHER
Responsible Party
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Jie Li
Principal Investigator
Locations
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Sichuan Academy of Medical Science Sichuan Provincial Hosptial
Chengdu, Sichuan, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2024-KY76
Identifier Type: -
Identifier Source: org_study_id
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