NCT03154892

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 7, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 16, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

May 23, 2018

Status Verified

May 1, 2018

Enrollment Period

9 months

First QC Date

May 7, 2017

Last Update Submit

May 21, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • NVI/NVA

    Changes in extent of iris or angle neovascularization

    1 week and 1 month after operation

Secondary Outcomes (2)

  • IOP

    1 week and 1 month after operation

  • BCVA

    1 week and 1 month after operation

Study Arms (2)

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

Intracameral Conbercept injection for the treatment of NVG

Intracameral injection

Intravitreal Conbercept injection for the treatment of NVG

Intravitreal injection

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ophthalmology, Second affiliated hospital of Xian Jiaotong University

Xi'an, Shaanxi, 710004, China

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Glaucoma, Neovascular

Interventions

Intracameral InjectionIntravitreal Injections

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

Injections, IntraocularInjectionsDrug Administration RoutesDrug TherapyTherapeutics

Study Officials

  • Ling Bai, MD,PhD

    Second affiliated hospital of Xian Jiaotong University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2017

First Posted

May 16, 2017

Study Start

April 1, 2017

Primary Completion

December 31, 2017

Study Completion

December 31, 2017

Last Updated

May 23, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

No plan to share IPD

Locations