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The Effect of Conbercept Injection Through Different Routes for Neovascular Glaucoma

Primary Purpose

Neovascular Glaucoma

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Intracameral injection
Intravitreal injection
Sponsored by
Second Affiliated Hospital of Xi'an Jiaotong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neovascular Glaucoma

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Ophthalmology, Second affiliated hospital of Xian Jiaotong University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intracameral injection

Intravitreal injection

Arm Description

Intracameral injection of conbercept for the treatment of NVG

Intravitreal injection of conbercept for the treatment of NVG

Outcomes

Primary Outcome Measures

NVI/NVA
Changes in extent of iris or angle neovascularization

Secondary Outcome Measures

IOP
Changes in Intraocular pressure
BCVA
Changes in best corrected visual acuity

Full Information

First Posted
May 7, 2017
Last Updated
May 21, 2018
Sponsor
Second Affiliated Hospital of Xi'an Jiaotong University
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1. Study Identification

Unique Protocol Identification Number
NCT03154892
Brief Title
The Effect of Conbercept Injection Through Different Routes for Neovascular Glaucoma
Official Title
The Effect of Conbercept Injection Through Different Routes for Neovascular Glaucoma
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
December 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital of Xi'an Jiaotong University

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neovascular Glaucoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intracameral injection
Arm Type
Experimental
Arm Description
Intracameral injection of conbercept for the treatment of NVG
Arm Title
Intravitreal injection
Arm Type
Active Comparator
Arm Description
Intravitreal injection of conbercept for the treatment of NVG
Intervention Type
Procedure
Intervention Name(s)
Intracameral injection
Intervention Description
Intracameral Conbercept injection for the treatment of NVG
Intervention Type
Procedure
Intervention Name(s)
Intravitreal injection
Intervention Description
Intravitreal Conbercept injection for the treatment of NVG
Primary Outcome Measure Information:
Title
NVI/NVA
Description
Changes in extent of iris or angle neovascularization
Time Frame
1 week and 1 month after operation
Secondary Outcome Measure Information:
Title
IOP
Description
Changes in Intraocular pressure
Time Frame
1 week and 1 month after operation
Title
BCVA
Description
Changes in best corrected visual acuity
Time Frame
1 week and 1 month after operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ling Bai, MD,PhD
Organizational Affiliation
Second affiliated hospital of Xian Jiaotong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Ophthalmology, Second affiliated hospital of Xian Jiaotong University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710004
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No plan to share IPD
Citations:
PubMed Identifier
35083234
Citation
Bai L, Wang Y, Liu X, Zheng Y, Wang W, He N, Tariq F, Wang F, Zhang S. The Optimization of an Anti-VEGF Therapeutic Regimen for Neovascular Glaucoma. Front Med (Lausanne). 2022 Jan 10;8:766032. doi: 10.3389/fmed.2021.766032. eCollection 2021.
Results Reference
derived

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The Effect of Conbercept Injection Through Different Routes for Neovascular Glaucoma

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