NCT02857517

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.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

June 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 27, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 5, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Last Updated

August 11, 2016

Status Verified

August 1, 2016

Enrollment Period

2 years

First QC Date

July 27, 2016

Last Update Submit

August 9, 2016

Conditions

Idiopathic Choroidal Neovascularization

Outcome Measures

Primary Outcomes (8)

  • visual acuity(Snellen chart)

    baseline

  • visual acuity(Snellen chart)

    Change from Baseline visual acuity at one day after injection

  • visual acuity(Snellen chart)

    Change from Baseline visual acuity at one week after injection

  • visual acuity(Snellen chart)

    Change from Baseline visual acuity at four weeks after injection

  • visual acuity

    Change from Baseline visual acuity at eight weeks after injection

  • visual acuity(Snellen chart)

    Change from Baseline visual acuity at 12weeks after injection

  • visual acuity(Snellen chart)

    Change from Baseline visual acuity at half year after injection

  • visual acuity(Snellen chart)

    Change from Baseline visual acuity at 1 year after injection

Secondary Outcomes (6)

  • macular central fovea thickness(OCT)

    baseline

  • macular central fovea thickness

    Change from Baseline macular central fovea thickness at four weeks after injection

  • macular central fovea thickness(OCT)

    Change from Baseline macular central fovea thickness at eight weeks after injection

  • macular central fovea thickness(OCT)

    Change from Baseline macular central fovea thickness at 12 weeks after injection

  • macular central fovea thickness(OCT)

    Change from Baseline macular central fovea thickness at half year after injection

  • +1 more secondary outcomes

Study Arms (1)

intravitreal 0.05ml conbercept for ICNV

EXPERIMENTAL

0.05ml conbercept ,1 injection with PRN

Drug: conbercept

Interventions

conberceptDRUG

0.05ml conbercept

Also known as: conbercept fusion protein
intravitreal 0.05ml conbercept for ICNV

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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:
  • AMD
  • 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
  • Retinal pigment epithelial tear reaching the macula in the studied eye
  • Medical history of intravitreal medical device in the studied eye
  • Medical history of auto-immune or idiopathic uveitis
  • Proved diabetic retinopathy
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tianjin Medical University Eye Hospital

Tianjin, Tianjin Municipality, 300384, China

RECRUITING

MeSH Terms

Interventions

KH902 fusion protein

Central Study Contacts

Mingfei Jiao, master

CONTACT

18630956101jiaomingfei2004@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 27, 2016

First Posted

August 5, 2016

Study Start

June 1, 2016

Primary Completion

June 1, 2018

Last Updated

August 11, 2016

Record last verified: 2016-08

Locations

CN(1)