Idiopathic Choroidal Neovascularization
Conditions
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.
Interventions
DRUGconbercept
0.05ml conbercept
Sponsors
Jiao Mingfei
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| visual acuity(Snellen chart) | baseline |
| visual acuity | Change from Baseline visual acuity at eight weeks after injection |
Secondary
| Measure | Time frame |
|---|---|
| macular central fovea thickness(OCT) | baseline |
| macular central fovea thickness | Change from Baseline macular central fovea thickness at four weeks after injection |
Countries
China
Contacts
Primary ContactMingfei Jiao, master
Outcome results
None listed