Back to resultsEffect of Postvitrectomy Proactive Use of Conbercept on Postoperative Complications in PDR Patients
Primary Purpose
Proliferative Diabetic Retinopathy
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
proactive Anti-VEGF (conbercept) use
passive Anti-VEGF (conbercept) use
Sponsored by
About this trial
This is an interventional prevention trial for Proliferative Diabetic Retinopathy focused on measuring vitrectomy
Eligibility Criteria
Inclusion Criteria: PDR patients undergoing vitrectomy Exclusion Criteria: patients who had received intravitreal injection or systemic use of all types of anti-VEGF agents in the recent three months before vitrectomy patients who had received intravitreal injection or systemic use of all types of steroid in the recent one month before vitrectomy patients who had received complete PRP before vitrectomy patients who are pregnant
Sites / Locations
- Peking University Third HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
group 1 (proactive use of conbercept after vitrectomy)
group 2 (passive use of conbercept after vitrectomy)
Arm Description
proactive use of conbercept after vitrectomy
passive use of conbercept after vitrectomy
Outcomes
Primary Outcome Measures
rate of postvitrectomy complication
postvitrectomy DME, VH (recurrent or nonabsorbent), NVG
Secondary Outcome Measures
postvitrectomy BCVA
BCVA at 1,3,6 month after vitrectomy
Full Information
NCT ID
NCT05642793
First Posted
November 30, 2022
Last Updated
December 13, 2022
Sponsor
Peking University Third Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05642793
Brief Title
Effect of Postvitrectomy Proactive Use of Conbercept on Postoperative Complications in PDR Patients
Official Title
Effect of Postvitrectomy Proactive Use of Conbercept on Postoperative Complications in PDR Patients
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University Third Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is an unmasking randomized clinical trial. the main purpose of this study is to analyze whether posvitrectomy proactive use of conbercept can reduce the rate of postoperative complication in PDR patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Proliferative Diabetic Retinopathy
Keywords
vitrectomy
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
group 1 (proactive use of conbercept after vitrectomy)
Arm Type
Experimental
Arm Description
proactive use of conbercept after vitrectomy
Arm Title
group 2 (passive use of conbercept after vitrectomy)
Arm Type
Experimental
Arm Description
passive use of conbercept after vitrectomy
Intervention Type
Drug
Intervention Name(s)
proactive Anti-VEGF (conbercept) use
Intervention Description
preventive intravitreal injection of conbercept 2 weeks after vitrectomy, and repeat at 5 weeks and 8 weeks if either of the following is present: intravitreal VEGF concentration at 2 weeks postop is higher than 100 pg/ml, or clinical presentation of DME, VH or NVG.
Intervention Type
Drug
Intervention Name(s)
passive Anti-VEGF (conbercept) use
Intervention Description
No intravitreal injection of conbercept is used until the patient present with postoperative DME, VH, NVG
Primary Outcome Measure Information:
Title
rate of postvitrectomy complication
Description
postvitrectomy DME, VH (recurrent or nonabsorbent), NVG
Time Frame
6 months
Secondary Outcome Measure Information:
Title
postvitrectomy BCVA
Description
BCVA at 1,3,6 month after vitrectomy
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
PDR patients undergoing vitrectomy
Exclusion Criteria:
patients who had received intravitreal injection or systemic use of all types of anti-VEGF agents in the recent three months before vitrectomy
patients who had received intravitreal injection or systemic use of all types of steroid in the recent one month before vitrectomy
patients who had received complete PRP before vitrectomy
patients who are pregnant
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Huijin Chen, Dr.
Phone
86-010-82266359
Email
chjdoc@aliyun.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huijin Chen, Dr.
Organizational Affiliation
Peking University Third Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University Third Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huijin Chen, Dr.
Phone
86-010-82266359
12. IPD Sharing Statement
Learn more about this trial
Effect of Postvitrectomy Proactive Use of Conbercept on Postoperative Complications in PDR Patients
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