Intravitreal Conbercept for Idiopathic Choroidal Neovascularization

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiao Mingfei

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