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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Sichuan
-
Chengdu, Sichuan, China, 610014
- Sichuan Academy of Medical Science Sichuan Provincial Hosptial
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 3-Day Conbercept-to-Vitrectomy Interval
Participants received a single intravitreal injection of conbercept (0.5 mg/0.05
mL) 3 days before pars plana vitrectomy.
|
Time point of injecting anti-VEGF drugs
|
|
Experimental: 7-Day Conbercept-to-Vitrectomy Interval
Participants received a single intravitreal injection of conbercept (0.5 mg/0.05
mL) 7 days before pars plana vitrectomy.
|
Time point of injecting anti-VEGF drugs
|
|
Experimental: 14-Day Conbercept-to-Vitrectomy Interval
Participants received a single intravitreal injection of conbercept (0.5 mg/0.05
mL) 14 days before pars plana vitrectomy.
|
Time point of injecting anti-VEGF drugs
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Active Retinal Neovascularization Tufts Assessed by Intraoperative Fluorescein Angiography
Time Frame: Intraoperatively, 1 to 3 minutes after fluorescein injection
|
Number of active retinal neovascularization tufts identified on intraoperative fluorescein angiography images.
|
Intraoperatively, 1 to 3 minutes after fluorescein injection
|
|
Size of Active Retinal Neovascularization Assessed by Intraoperative Fluorescein Angiography
Time Frame: Intraoperatively, 1 to 3 minutes after fluorescein injection
|
Neovascularization size was quantified by measuring the maximal linear diameter and normalizing it to the vertical optic disc diameter, expressed in papillary diameters (PD).
|
Intraoperatively, 1 to 3 minutes after fluorescein injection
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-KY76
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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