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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intravitreal 0.05ml conbercept for ICNV | Experimental | 0.05ml conbercept ,1 injection with PRN |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| conbercept | Drug | 0.05ml conbercept |
|
| 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 |
| 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 | |
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Inclusion Criteria:
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:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mingfei Jiao, master | Contact | 18630956101 | jiaomingfei2004@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Medical University Eye Hospital | Recruiting | Tianjin | Tianjin Municipality | 300384 | China |
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| ID | Term |
|---|---|
| C527363 | KH902 fusion protein |
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| 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 |