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

Proliferative Diabetic Retinopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05642793
• Other study ID #: PDR vitrectomy1
• Status: Recruiting
• Phase: Phase 2
• Start date: April 1, 2022
• Est. completion date: March 1, 2024

Study information

• Verified date: December 2022
• Source: Peking University Third Hospital
• Contact: Huijin Chen, Dr.
• Phone: 86-010-82266359
• Email: chjdoc[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: March 1, 2024
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Postoperative Complications
• Proliferative Diabetic Retinopathy

Intervention

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.
• passive Anti-VEGF (conbercept) use
No intravitreal injection of conbercept is used until the patient present with postoperative DME, VH, NVG

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of postvitrectomy complication	postvitrectomy DME, VH (recurrent or nonabsorbent), NVG	6 months
Secondary	postvitrectomy BCVA	BCVA at 1,3,6 month after vitrectomy	6 months