The Effect of Conbercept Injection Through Different Routes for Neovascular Glaucoma

Not Applicable

Completed

• Conditions: Neovascular Glaucoma
• Interventions: Procedure: Intravitreal injection; Procedure: Intracameral injection

• Registration Number: NCT03154892
• Lead Sponsor: Second Affiliated Hospital of Xi'an Jiaotong University

Brief Summary

The neovascular glaucoma (NVG) is a refractory type of secondary glaucoma and often lead to frustrated treatment and blindness. It has been confirmed high levels of vascular endothelial growth factor (VEGF) in NVG. Conbercept is an anti-VEGF agent，its role in regression of other neovascular disorders such as wet-type age-related macular degeneration and diabetic retinopathy has been described. Investigators aim to evaluate the efficacy and safety of intracameral and intravitreal injection of conbercept for the treatment of NVG.

Detailed Description

The neovascular glaucoma (NVG) is a refractory type of secondary glaucoma and often lead to frustrated treatment and blindness. It has been confirmed high levels of vascular endothelial growth factor (VEGF) in NVG. Conbercept is an anti-VEGF agent，Its role in regression of other neovascular disorders such as wet-type age-related macular degeneration and diabetic retinopathy has been described. The intravitreal injection of anti-VEGF agent has shown its therapeutic potential for the early stage of NVG, but not for the late stage. Intracameral injection maybe used as an alternative way for administration. Investigators aim to evaluate the efficacy and safety of intracameral and intravitreal injection of conbercept for the treatment of NVG.

Study Timeline

• Study Start: 2017-04-01
• Study First Submitted: 2017-05-07
• Study First Submitted QC: 2017-05-14
• Study First Posted: 2017-05-16
• Primary Completion: 2017-12-31
• Study Completion: 2017-12-31
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-21
• Last Update Posted: 2018-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patients with a diagnosis of neovascular glaucoma (Stage 1-2-3)
• Individuals who are ages 20-80 years old; male or female of chinese
• Visual acuity of light perception or better in the study eye
• Willing and able to comply with clinic visits and study-related procedures
• Provide signed informed consent

Exclusion Criteria

• Use of intraocular anti-VEGF agents in the study eye in the past 3 months.
• Active ocular or periocular infection in the study eye
• Uncontrolled Blood Pressure
• Thromboembolism
• Congestive Heart Failure
• Renal Failure
• History of myocardial infarction
• History of Stroke
• Pregnant or breast-feeding women
• Participation in another simultaneous medical investigator or trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intravitreal injection	Intravitreal injection	Intravitreal injection of conbercept for the treatment of NVG
Intracameral injection	Intracameral injection	Intracameral injection of conbercept for the treatment of NVG

Primary Outcome Measures

Name	Time	Method
NVI/NVA	1 week and 1 month after operation	Changes in extent of iris or angle neovascularization

Secondary Outcome Measures

Name	Time	Method
BCVA	1 week and 1 month after operation	Changes in best corrected visual acuity
IOP	1 week and 1 month after operation	Changes in Intraocular pressure

Trial Locations

Locations (1)

Department of Ophthalmology, Second affiliated hospital of Xian Jiaotong University; 🇨🇳 Xi'an, Shaanxi, China