Intravitreal Conbercept for Idiopathic Choroidal Neovascularization

Phase 2

• Conditions: Idiopathic Choroidal Neovascularization
• Interventions: Drug: conbercept

• Registration Number: NCT02857517
• Lead Sponsor: Jiao Mingfei

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-07-27
• Status Verified: 2016-08
• Study First Submitted QC: 2016-08-04
• Study First Posted: 2016-08-05
• Last Update Submitted: 2016-08-09
• Last Update Posted: 2016-08-11
• Primary Completion: 2018-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
intravitreal 0.05ml conbercept for ICNV	conbercept	0.05ml conbercept ,1 injection with PRN

Primary Outcome Measures

Name	Time	Method
visual acuity(Snellen chart)	Change from Baseline visual acuity at 1 year after injection
visual acuity	Change from Baseline visual acuity at eight weeks after injection

Secondary Outcome Measures

Name	Time	Method
macular central fovea thickness(OCT)	Change from Baseline macular central fovea thickness at 1 year after injection
macular central fovea thickness	Change from Baseline macular central fovea thickness at four weeks after injection

Trial Locations

Locations (1)

Tianjin Medical University Eye Hospital; 🇨🇳 Tianjin, Tianjin, China