The Effect of Conbercept Injection Through Different Rout... | NCT03154892

Studies
The Effect of Conbercept Injection Through Different Routes for Neovascular Glaucoma

NCT03154892

Sponsor

Second Affiliated Hospital of Xi'an Jiaotong University

Status

Completed

Last Update Posted

May 23, 2018Actual

Enrollment

30Actual

Phase

Not Applicable

Conditions

Neovascular Glaucoma

Interventions

Intracameral injection
Intravitreal injection

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2017Actual

Primary Completion Date

Dec 31, 2017Actual

Completion Date

Dec 31, 2017Actual

First Submitted Date

May 7, 2017

First Submission Date that Met QC Criteria

May 14, 2017

First Posted Date

May 16, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 21, 2018

Last Update Posted Date

May 23, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intracameral injection	Experimental	Intracameral injection of conbercept for the treatment of NVG	Procedure: Intracameral injection
Intravitreal injection	Active Comparator	Intravitreal injection of conbercept for the treatment of NVG	Procedure: Intravitreal injection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Intracameral injection	Procedure	Intracameral Conbercept injection for the treatment of NVG	Intracameral injection

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ling Bai, MD,PhD	Second affiliated hospital of Xian Jiaotong University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Ophthalmology, Second affiliated hospital of Xian Jiaotong University		Xi'an	Shaanxi	710004	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35083234	Derived	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.

ID	Term
D005901	Glaucoma
D009798	Ocular Hypertension
D005128	Eye Diseases

ID	Term
D000097807	Intracameral Injection
D058449	Intravitreal Injections

ID	Term
D056965	Injections, Intraocular
D007267	Injections
D004333	Drug Administration Routes
D004358	Drug Therapy