Intravitreal Conbercept for Idiopathic Choroidal Neovascularization

Idiopathic Choroidal Neovascularization Clinical Trial

Official title:

Intravitreal Conbercept for Idiopathic Choroidal Neovascularization

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02857517
• Other study ID #: TJMUEH001
• Status: Recruiting
• Phase: Phase 2
• First received: July 27, 2016
• Last updated: August 9, 2016
• Start date: June 2016

Study information

• Verified date: August 2016
• Source: Tianjin Medical University Eye Hospital
• Contact: Mingfei Jiao, master
• Phone: 18630956101
• Email: jiaomingfei2004[@]163.com
• Is FDA regulated: No
• Health authority: China: Chinese Medical Association
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Choroidal Neovascularization
• Idiopathic Choroidal Neovascularization
• Neovascularization, Pathologic

Intervention

Drug:
• conbercept
0.05ml conbercept

Locations

Country	Name	City	State
China	Tianjin Medical University Eye Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Jiao Mingfei

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	visual acuity(Snellen chart)		baseline	Yes
Primary	visual acuity(Snellen chart)		Change from Baseline visual acuity at one day after injection	Yes
Primary	visual acuity(Snellen chart)		Change from Baseline visual acuity at one week after injection	Yes
Primary	visual acuity(Snellen chart)		Change from Baseline visual acuity at four weeks after injection	Yes
Primary	visual acuity		Change from Baseline visual acuity at eight weeks after injection	Yes
Primary	visual acuity(Snellen chart)		Change from Baseline visual acuity at 12weeks after injection	Yes
Primary	visual acuity(Snellen chart)		Change from Baseline visual acuity at half year after injection	Yes
Primary	visual acuity(Snellen chart)		Change from Baseline visual acuity at 1 year after injection	Yes
Secondary	macular central fovea thickness(OCT)		baseline	Yes
Secondary	macular central fovea thickness		Change from Baseline macular central fovea thickness at four weeks after injection	Yes
Secondary	macular central fovea thickness(OCT)		Change from Baseline macular central fovea thickness at eight weeks after injection	Yes
Secondary	macular central fovea thickness(OCT)		Change from Baseline macular central fovea thickness at 12 weeks after injection	Yes
Secondary	macular central fovea thickness(OCT)		Change from Baseline macular central fovea thickness at half year after injection	Yes
Secondary	macular central fovea thickness(OCT)		Change from Baseline macular central fovea thickness at 1 year after injection	Yes