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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03154892
Other study ID # Conbercept Injection
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2017
Est. completion date December 31, 2017

Study information

Verified date May 2018
Source Second Affiliated Hospital of Xi'an Jiaotong University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date December 31, 2017
Est. primary completion date December 31, 2017
Accepts healthy volunteers No
Gender All
Age group 20 Years to 80 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Procedure:
Intracameral injection
Intracameral Conbercept injection for the treatment of NVG
Intravitreal injection
Intravitreal Conbercept injection for the treatment of NVG

Locations

Country Name City State
China Department of Ophthalmology, Second affiliated hospital of Xian Jiaotong University Xi'an Shaanxi

Sponsors (1)

Lead Sponsor Collaborator
Second Affiliated Hospital of Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary NVI/NVA Changes in extent of iris or angle neovascularization 1 week and 1 month after operation
Secondary IOP Changes in Intraocular pressure 1 week and 1 month after operation
Secondary BCVA Changes in best corrected visual acuity 1 week and 1 month after operation
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