Effect of Postvitrectomy Proactive Use of Conbercept on Postoperative Complications in PDR Patients
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2022
CompletedFirst Submitted
Initial submission to the registry
November 30, 2022
CompletedFirst Posted
Study publicly available on registry
December 8, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2024
CompletedDecember 14, 2022
December 1, 2022
1.5 years
November 30, 2022
December 13, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
rate of postvitrectomy complication
postvitrectomy DME, VH (recurrent or nonabsorbent), NVG
6 months
Secondary Outcomes (1)
postvitrectomy BCVA
6 months
Study Arms (2)
group 1 (proactive use of conbercept after vitrectomy)
EXPERIMENTALproactive use of conbercept after vitrectomy
group 2 (passive use of conbercept after vitrectomy)
EXPERIMENTALpassive use of conbercept after vitrectomy
Interventions
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.
No intravitreal injection of conbercept is used until the patient present with postoperative DME, VH, NVG
Eligibility Criteria
You may qualify if:
- PDR patients undergoing vitrectomy
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking University Third Hospital
Beijing, Beijing Municipality, 100191, China
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Huijin Chen, Dr.
Peking University Third Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
November 30, 2022
First Posted
December 8, 2022
Study Start
April 1, 2022
Primary Completion
September 30, 2023
Study Completion
March 1, 2024
Last Updated
December 14, 2022
Record last verified: 2022-12