- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03154892
The Effect of Conbercept Injection Through Different Routes for Neovascular Glaucoma
May 21, 2018 updated by: Second Affiliated Hospital of Xi'an Jiaotong University
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
Status
Completed
Conditions
Intervention / Treatment
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
Additional Relevant MeSH Terms
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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