Intravitreal Conbercept for Idiopathic Choroidal Neovascularization

Study Overview
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Brief Summary
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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.

Official Title
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Intravitreal Conbercept for Idiopathic Choroidal Neovascularization

Conditions
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Idiopathic Choroidal Neovascularization

Intervention / Treatment
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* Drug: conbercept


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intravitreal 0.05ml conbercept for ICNV<br>0.05ml conbercept ,1 injection with PRN | Drug: conbercept<br>* 0.05ml conbercept<br>* Other names: conbercept fusion protein;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| macular central fovea thickness(OCT) |  | Change from Baseline macular central fovea thickness at 1 year after injection |