The Effect of Conbercept Injection Through Different Routes for Neovascular Glaucoma

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.

Study Overview

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Shaanxi
      • Xi'an, Shaanxi, China, 710004
        • Department of Ophthalmology, Second affiliated hospital of Xian Jiaotong University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intracameral injection
Intracameral injection of conbercept for the treatment of NVG
Intracameral Conbercept injection for the treatment of NVG
Active Comparator: Intravitreal injection
Intravitreal injection of conbercept for the treatment of NVG
Intravitreal Conbercept injection for the treatment of NVG

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NVI/NVA
Time Frame: 1 week and 1 month after operation
Changes in extent of iris or angle neovascularization
1 week and 1 month after operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IOP
Time Frame: 1 week and 1 month after operation
Changes in Intraocular pressure
1 week and 1 month after operation
BCVA
Time Frame: 1 week and 1 month after operation
Changes in best corrected visual acuity
1 week and 1 month after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ling Bai, MD,PhD, Second affiliated hospital of Xian Jiaotong University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2017

Primary Completion (Actual)

December 31, 2017

Study Completion (Actual)

December 31, 2017

Study Registration Dates

First Submitted

May 7, 2017

First Submitted That Met QC Criteria

May 14, 2017

First Posted (Actual)

May 16, 2017

Study Record Updates

Last Update Posted (Actual)

May 23, 2018

Last Update Submitted That Met QC Criteria

May 21, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • Conbercept Injection

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

No plan to share IPD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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