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

Phase 2

Recruiting

• Conditions: Proliferative Diabetic Retinopathy
• Interventions: Drug: proactive Anti-VEGF (conbercept) use; Drug: passive Anti-VEGF (conbercept) use

• Registration Number: NCT05642793
• Lead Sponsor: Peking University Third Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-01
• Study First Submitted: 2022-11-30
• Study First Submitted QC: 2022-11-30
• Status Verified: 2022-12
• Study First Posted: 2022-12-08
• Last Update Submitted: 2022-12-13
• Last Update Posted: 2022-12-14
• Primary Completion: 2023-09-30
• Study Completion: 2024-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• PDR patients undergoing vitrectomy

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group 1 (proactive use of conbercept after vitrectomy)	proactive Anti-VEGF (conbercept) use	proactive use of conbercept after vitrectomy
group 2 (passive use of conbercept after vitrectomy)	passive Anti-VEGF (conbercept) use	passive use of conbercept after vitrectomy

Primary Outcome Measures

Name	Time	Method
rate of postvitrectomy complication	6 months	postvitrectomy DME, VH (recurrent or nonabsorbent), NVG

Secondary Outcome Measures

Name	Time	Method
postvitrectomy BCVA	6 months	BCVA at 1,3,6 month after vitrectomy

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China