Intravitreal Conbercept for Idiopathic Choroidal Neovascularization

Jiao Mingfei1 site in 1 country50 target enrollmentJune 2016

ConditionsIdiopathic Choroidal Neovascularization

Interventionsconbercept

Drugsconbercept

Overview

Phase: Phase 2
Intervention: conbercept
Conditions: Idiopathic Choroidal Neovascularization
Sponsor: Jiao Mingfei
Enrollment: 50
Locations: 1
Primary Endpoint: visual acuity(Snellen chart)
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the efficacy of intravitreal anti-vascular endothelial growth factor (anti-VEGF) therapy as primary treatment for ICNV.

Registry

clinicaltrials.gov

Start Date

June 2016

End Date

June 2018

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Jiao Mingfei

Responsible Party

Sponsor Investigator

Principal Investigator

Jiao Mingfei

Principal Investigator

Tianjin Medical University Eye Hospital

Eligibility Criteria

Inclusion Criteria

•Patient who give voluntary signed informed consent
•Patient affiliated with the Tianjin Medical University Eye Hospital or similar
•Patient with ICNV with active primary subfoveal, retrofoveal or juxtafoveal lesions that affect the fovea as evidenced by angiography (fluorescein and/or indocyanin green) and/or SD-OCT in the studied eye
•Patient willing, committed and able to return for all clinic visits and complete all study-related procedures

Exclusion Criteria

•Pregnant women
•Sexually active men or women of childbearing potential who are unwilling to practice adequate contraception during the study
•Patient who is protected adults according to the terms of the law (French public health laws)
•Involvement in another clinical trial (studied eye and/or the other eye)
•Patient with non-ICNV, especially:
•High myopia defined as refraction ≥ - 6 diopters
•Other curative treatment of ICNV in the studied eye during the last 3 months before the first intravitreal injection: anti-VEGF therapy, juxta- or extra-foveal macular laser, photodynamic therapy, surgery, external radiotherapy, transpupillary thermotherapy ...
•Medical history of retrofoveal focal macular laser photocoagulation in the studied eye
•Subretinal haemorrhage reaching the fovea centre, with a size \> 50% of the lesion area
•Fibrosis or retrofoveal retinal atrophy in the studied eye

Arms & Interventions

intravitreal 0.05ml conbercept for ICNV

0.05ml conbercept ,1 injection with PRN

Intervention: conbercept

Outcomes

Primary Outcomes

visual acuity(Snellen chart)

Time Frame: Change from Baseline visual acuity at 1 year after injection

visual acuity

Time Frame: Change from Baseline visual acuity at eight weeks after injection

Secondary Outcomes

macular central fovea thickness(OCT)(Change from Baseline macular central fovea thickness at 1 year after injection)
macular central fovea thickness(Change from Baseline macular central fovea thickness at four weeks after injection)