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Intravitreal Conbercept for Idiopathic Choroidal Neovascularization

Primary Purpose

Idiopathic Choroidal Neovascularization

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

conbercept

About this trial

This is an interventional treatment trial for Idiopathic Choroidal Neovascularization

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept 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

Sites / Locations

Tianjin Medical University Eye HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

intravitreal 0.05ml conbercept for ICNV

Arm Description

0.05ml conbercept ,1 injection with PRN

Outcomes

Primary Outcome Measures

visual acuity(Snellen chart)

visual acuity

visual acuity(Snellen chart)

Secondary Outcome Measures

macular central fovea thickness(OCT)

macular central fovea thickness

macular central fovea thickness(OCT)

Full Information

NCT ID

NCT02857517

First Posted

July 27, 2016

Last Updated

August 9, 2016

Sponsor

Jiao Mingfei

1. Study Identification

Unique Protocol Identification Number

NCT02857517

Brief Title

Intravitreal Conbercept for Idiopathic Choroidal Neovascularization

Official Title

Intravitreal Conbercept for Idiopathic Choroidal Neovascularization

Study Type

Interventional

2. Study Status

Record Verification Date

August 2016

Overall Recruitment Status

Unknown status

Study Start Date

June 2016 (undefined)

Primary Completion Date

June 2018 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Jiao Mingfei

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Idiopathic Choroidal Neovascularization

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

intravitreal 0.05ml conbercept for ICNV

Arm Type

Experimental

Arm Description

0.05ml conbercept ,1 injection with PRN

Intervention Type

Drug

Intervention Name(s)

conbercept

Other Intervention Name(s)

conbercept fusion protein

Intervention Description

0.05ml conbercept

Primary Outcome Measure Information:

Title

visual acuity(Snellen chart)

Time Frame

baseline

Title

visual acuity(Snellen chart)

Time Frame

Change from Baseline visual acuity at one day after injection

Title

visual acuity(Snellen chart)

Time Frame

Change from Baseline visual acuity at one week after injection

Title

visual acuity(Snellen chart)

Time Frame

Change from Baseline visual acuity at four weeks after injection

Title

visual acuity

Time Frame

Change from Baseline visual acuity at eight weeks after injection

Title

visual acuity(Snellen chart)

Time Frame

Change from Baseline visual acuity at 12weeks after injection

Title

visual acuity(Snellen chart)

Time Frame

Change from Baseline visual acuity at half year after injection

Title

visual acuity(Snellen chart)

Time Frame

Change from Baseline visual acuity at 1 year after injection

Secondary Outcome Measure Information:

Title

macular central fovea thickness(OCT)

Time Frame

baseline

Title

macular central fovea thickness

Time Frame

Change from Baseline macular central fovea thickness at four weeks after injection

Title

macular central fovea thickness(OCT)

Time Frame

Change from Baseline macular central fovea thickness at eight weeks after injection

Title

macular central fovea thickness(OCT)

Time Frame

Change from Baseline macular central fovea thickness at 12 weeks after injection

Title

macular central fovea thickness(OCT)

Time Frame

Change from Baseline macular central fovea thickness at half year after injection

Title

macular central fovea thickness(OCT)

Time Frame

Change from Baseline macular central fovea thickness at 1 year after injection

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mingfei Jiao, master

Phone

18630956101

jiaomingfei2004@163.com

Facility Information:

Facility Name

Tianjin Medical University Eye Hospital

City

Tianjin

State/Province

Tianjin

ZIP/Postal Code

300384

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mingfei Jiao

Phone

18630956101

jiaomingfei2004@163.com

12. IPD Sharing Statement

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Intravitreal Conbercept for Idiopathic Choroidal Neovascularization

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