Effect of Postvitrectomy Proactive Use of Conbercept on Postoperative Complications in PDR Patients

December 13, 2022 updated by: Chen Huijin, Peking University Third Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100191
        • Recruiting
        • Peking University Third Hospital
        • Contact:
          • Huijin Chen, Dr.
          • Phone Number: 86-010-82266359

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: group 1 (proactive use of conbercept after vitrectomy)
proactive use of conbercept after vitrectomy
Drug: proactive Anti-VEGF (conbercept) use
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.
Experimental: group 2 (passive use of conbercept after vitrectomy)
passive use of conbercept after vitrectomy
Drug: passive Anti-VEGF (conbercept) use
No intravitreal injection of conbercept is used until the patient present with postoperative DME, VH, NVG

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
rate of postvitrectomy complication
Time Frame: 6 months
postvitrectomy DME, VH (recurrent or nonabsorbent), NVG
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postvitrectomy BCVA
Time Frame: 6 months
BCVA at 1,3,6 month after vitrectomy
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Third Hospital

Investigators

  • Principal Investigator: Huijin Chen, Dr., Peking University Third Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2022

Primary Completion (Anticipated)

September 30, 2023

Study Completion (Anticipated)

March 1, 2024

Study Registration Dates

First Submitted

November 30, 2022

First Submitted That Met QC Criteria

November 30, 2022

First Posted (Actual)

December 8, 2022

Study Record Updates

Last Update Posted (Actual)

December 14, 2022

Last Update Submitted That Met QC Criteria

December 13, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PDR vitrectomy1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Proliferative Diabetic Retinopathy

Clinical Trials on proactive Anti-VEGF (conbercept) use

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malawi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe