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

NCT ID: NCT05642793

Last Updated: 2022-12-14

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-01

Study Completion Date

2024-03-01

Brief Summary

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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.

Detailed Description

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Conditions

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Proliferative Diabetic Retinopathy

Keywords

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vitrectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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group 1 (proactive use of conbercept after vitrectomy)

proactive use of conbercept after vitrectomy

Group Type EXPERIMENTAL

proactive Anti-VEGF (conbercept) use

Intervention Type DRUG

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.

group 2 (passive use of conbercept after vitrectomy)

passive use of conbercept after vitrectomy

Group Type EXPERIMENTAL

passive Anti-VEGF (conbercept) use

Intervention Type DRUG

No intravitreal injection of conbercept is used until the patient present with postoperative DME, VH, NVG

Interventions

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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.

Intervention Type DRUG

passive Anti-VEGF (conbercept) use

No intravitreal injection of conbercept is used until the patient present with postoperative DME, VH, NVG

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University Third Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chen Huijin

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Huijin Chen, Dr.

Role: PRINCIPAL_INVESTIGATOR

Peking University Third Hospital

Locations

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Peking University Third Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Huijin Chen, Dr.

Role: CONTACT

Phone: 86-010-82266359

Email: [email protected]

Facility Contacts

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Huijin Chen, Dr.

Role: primary

Other Identifiers

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PDR vitrectomy1

Identifier Type: -

Identifier Source: org_study_id