Intravitreal Conbercept for Idiopathic Choroidal Neovascularization

August 9, 2016 updated by: Jiao Mingfei
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Tianjin
      • Tianjin, Tianjin, China, 300384
        • Recruiting
        • Tianjin Medical University Eye Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

    • 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
  • Intra-ocular pressure ≥ 25 mmHg despite two topical hypotonic treatments
  • Aphakia or lack of lens capsule (not removed by YAG laser) in the studied eye
  • Arterial hypertension that is not controlled by an appropriate treatment
  • Previous or actual treatment with systemic administration of anti-VEGF therapy
  • Known hypersensitivity to aflibercept, or another drug composite of the medicinal product used; allergy to fluorescein, indocyanin green, anaesthetic eye drops
  • Active or suspected ocular or peri-ocular infection
  • Serious active intra-ocular inflammation in the studied eye
  • Medical history of intra-ocular surgery within 28 days before the first injection in the studied eye
  • Any illness or ocular condition that would require an intra-ocular surgery in the studied eye within 12 months after the inclusion
  • Follow up not possible during 12 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: intravitreal 0.05ml conbercept for ICNV
0.05ml conbercept ,1 injection with PRN
Drug: conbercept
0.05ml conbercept
Other Names:
  • conbercept fusion protein

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
visual acuity(Snellen chart)
Time Frame: baseline
baseline
visual acuity(Snellen chart)
Time Frame: Change from Baseline visual acuity at one day after injection
Change from Baseline visual acuity at one day after injection
visual acuity(Snellen chart)
Time Frame: Change from Baseline visual acuity at one week after injection
Change from Baseline visual acuity at one week after injection
visual acuity(Snellen chart)
Time Frame: Change from Baseline visual acuity at four weeks after injection
Change from Baseline visual acuity at four weeks after injection
visual acuity
Time Frame: Change from Baseline visual acuity at eight weeks after injection
Change from Baseline visual acuity at eight weeks after injection
visual acuity(Snellen chart)
Time Frame: Change from Baseline visual acuity at 12weeks after injection
Change from Baseline visual acuity at 12weeks after injection
visual acuity(Snellen chart)
Time Frame: Change from Baseline visual acuity at half year after injection
Change from Baseline visual acuity at half year after injection
visual acuity(Snellen chart)
Time Frame: Change from Baseline visual acuity at 1 year after injection
Change from Baseline visual acuity at 1 year after injection

Secondary Outcome Measures

Outcome Measure
Time Frame
macular central fovea thickness(OCT)
Time Frame: baseline
baseline
macular central fovea thickness
Time Frame: Change from Baseline macular central fovea thickness at four weeks after injection
Change from Baseline macular central fovea thickness at four weeks after injection
macular central fovea thickness(OCT)
Time Frame: Change from Baseline macular central fovea thickness at eight weeks after injection
Change from Baseline macular central fovea thickness at eight weeks after injection
macular central fovea thickness(OCT)
Time Frame: Change from Baseline macular central fovea thickness at 12 weeks after injection
Change from Baseline macular central fovea thickness at 12 weeks after injection
macular central fovea thickness(OCT)
Time Frame: Change from Baseline macular central fovea thickness at half year after injection
Change from Baseline macular central fovea thickness at half year after injection
macular central fovea thickness(OCT)
Time Frame: Change from Baseline macular central fovea thickness at 1 year after injection
Change from Baseline macular central fovea thickness at 1 year after injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiao Mingfei

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Anticipated)

June 1, 2018

Study Registration Dates

First Submitted

July 27, 2016

First Submitted That Met QC Criteria

August 4, 2016

First Posted (Estimate)

August 5, 2016

Study Record Updates

Last Update Posted (Estimate)

August 11, 2016

Last Update Submitted That Met QC Criteria

August 9, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TJMUEH001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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