Intravitreal Conbercept for Idiopathic Choroidal Neovascularization
Primary Purpose
Idiopathic Choroidal Neovascularization
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
conbercept
Sponsored by
About this trial
This is an interventional treatment trial for Idiopathic Choroidal Neovascularization
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:
- 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
Sites / Locations
- Tianjin Medical University Eye HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
intravitreal 0.05ml conbercept for ICNV
Arm Description
0.05ml conbercept ,1 injection with PRN
Outcomes
Primary Outcome Measures
visual acuity(Snellen chart)
visual acuity(Snellen chart)
visual acuity(Snellen chart)
visual acuity(Snellen chart)
visual acuity
visual acuity(Snellen chart)
visual acuity(Snellen chart)
visual acuity(Snellen chart)
Secondary Outcome Measures
macular central fovea thickness(OCT)
macular central fovea thickness
macular central fovea thickness(OCT)
macular central fovea thickness(OCT)
macular central fovea thickness(OCT)
macular central fovea thickness(OCT)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02857517
Brief Title
Intravitreal Conbercept for Idiopathic Choroidal Neovascularization
Official Title
Intravitreal Conbercept for Idiopathic Choroidal Neovascularization
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2016 (undefined)
Primary Completion Date
June 2018 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jiao Mingfei
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Choroidal Neovascularization
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
intravitreal 0.05ml conbercept for ICNV
Arm Type
Experimental
Arm Description
0.05ml conbercept ,1 injection with PRN
Intervention Type
Drug
Intervention Name(s)
conbercept
Other Intervention Name(s)
conbercept fusion protein
Intervention Description
0.05ml conbercept
Primary Outcome Measure Information:
Title
visual acuity(Snellen chart)
Time Frame
baseline
Title
visual acuity(Snellen chart)
Time Frame
Change from Baseline visual acuity at one day after injection
Title
visual acuity(Snellen chart)
Time Frame
Change from Baseline visual acuity at one week after injection
Title
visual acuity(Snellen chart)
Time Frame
Change from Baseline visual acuity at four weeks after injection
Title
visual acuity
Time Frame
Change from Baseline visual acuity at eight weeks after injection
Title
visual acuity(Snellen chart)
Time Frame
Change from Baseline visual acuity at 12weeks after injection
Title
visual acuity(Snellen chart)
Time Frame
Change from Baseline visual acuity at half year after injection
Title
visual acuity(Snellen chart)
Time Frame
Change from Baseline visual acuity at 1 year after injection
Secondary Outcome Measure Information:
Title
macular central fovea thickness(OCT)
Time Frame
baseline
Title
macular central fovea thickness
Time Frame
Change from Baseline macular central fovea thickness at four weeks after injection
Title
macular central fovea thickness(OCT)
Time Frame
Change from Baseline macular central fovea thickness at eight weeks after injection
Title
macular central fovea thickness(OCT)
Time Frame
Change from Baseline macular central fovea thickness at 12 weeks after injection
Title
macular central fovea thickness(OCT)
Time Frame
Change from Baseline macular central fovea thickness at half year after injection
Title
macular central fovea thickness(OCT)
Time Frame
Change from Baseline macular central fovea thickness at 1 year after injection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mingfei Jiao, master
Phone
18630956101
Email
jiaomingfei2004@163.com
Facility Information:
Facility Name
Tianjin Medical University Eye Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300384
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mingfei Jiao
Phone
18630956101
Email
jiaomingfei2004@163.com
12. IPD Sharing Statement
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Intravitreal Conbercept for Idiopathic Choroidal Neovascularization
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