Intravitreal Conbercept for Idiopathic Choroidal Neovascularization

NCT ID: NCT02857517

Last Updated: 2016-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Idiopathic Choroidal Neovascularization

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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intravitreal 0.05ml conbercept for ICNV

0.05ml conbercept ,1 injection with PRN

Group Type EXPERIMENTAL

conbercept

Intervention Type DRUG

0.05ml conbercept

Interventions

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conbercept

0.05ml conbercept

Intervention Type DRUG

Other Intervention Names

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conbercept fusion protein

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jiao Mingfei

OTHER

Sponsor Role lead

Responsible Party

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Jiao Mingfei

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Tianjin Medical University Eye Hospital

Tianjin, Tianjin Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Mingfei Jiao, master

Role: CONTACT

18630956101

Facility Contacts

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Mingfei Jiao

Role: primary

18630956101

Other Identifiers

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TJMUEH001

Identifier Type: -

Identifier Source: org_study_id

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