Intravitreal Conbercept for Idiopathic Choroidal Neovascularization

Jiao Mingfei

Status and phase: Unknown; Phase 2

Conditions: Idiopathic Choroidal Neovascularization

Treatments: Drug: conbercept

Study type: Interventional

Funder types: Other

Identifiers

NCT02857517

TJMUEH001

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

intravitreal 0.05ml conbercept for ICNV

Experimental group

Description:

0.05ml conbercept ,1 injection with PRN

Treatment:

Drug: conbercept