Intravitreal Conbercept for Idiopathic Choroidal Neovascularization
- Registration Number
- NCT02857517
- Lead Sponsor
- Jiao Mingfei
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 50
- 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
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Pregnant women
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Sexually active men or women of childbearing potential who are unwilling to practice adequate contraception during the study
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Patient who is protected adults according to the terms of the law (French public health laws)
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Involvement in another clinical trial (studied eye and/or the other eye)
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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 ...
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Medical history of retrofoveal focal macular laser photocoagulation in the studied eye
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Subretinal haemorrhage reaching the fovea centre, with a size > 50% of the lesion area
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Fibrosis or retrofoveal retinal atrophy in the studied eye
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Retinal pigment epithelial tear reaching the macula in the studied eye
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Medical history of intravitreal medical device in the studied eye
-
Medical history of auto-immune or idiopathic uveitis
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Proved diabetic retinopathy
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Intra-ocular pressure ≥ 25 mmHg despite two topical hypotonic treatments
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Aphakia or lack of lens capsule (not removed by YAG laser) in the studied eye
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Arterial hypertension that is not controlled by an appropriate treatment
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Previous or actual treatment with systemic administration of anti-VEGF therapy
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Known hypersensitivity to aflibercept, or another drug composite of the medicinal product used; allergy to fluorescein, indocyanin green, anaesthetic eye drops
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Active or suspected ocular or peri-ocular infection
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Serious active intra-ocular inflammation in the studied eye
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Medical history of intra-ocular surgery within 28 days before the first injection in the studied eye
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Any illness or ocular condition that would require an intra-ocular surgery in the studied eye within 12 months after the inclusion
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Follow up not possible during 12 months
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description intravitreal 0.05ml conbercept for ICNV conbercept 0.05ml conbercept ,1 injection with PRN
- Primary Outcome Measures
Name Time Method visual acuity(Snellen chart) Change from Baseline visual acuity at 1 year after injection visual acuity Change from Baseline visual acuity at eight weeks after injection
- Secondary Outcome Measures
Name Time Method 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
Related Research Topics
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Trial Locations
- Locations (1)
Tianjin Medical University Eye Hospital
🇨🇳Tianjin, Tianjin, China
Tianjin Medical University Eye Hospital🇨🇳Tianjin, Tianjin, ChinaMingfei JiaoContact18630956101jiaomingfei2004@163.com