Clinical trial NCT02857517: Intravitreal Conbercept for Idiopathic Choroidal Neovascularization
Official title: Intravitreal Conbercept for Idiopathic Choroidal Neovascularization
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Idiopathic Choroidal Neovascularization
Lead sponsor: Tianjin Medical University Eye Hospital
Sponsor class: OTHER
First posted: 2016-08-05
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: visual acuity(Snellen chart)
timeFrame: baseline
measure: visual acuity(Snellen chart)
timeFrame: Change from Baseline visual acuity at one day after injection
measure: visual acuity(Snellen chart)
timeFrame: Change from Baseline visual acuity at one week after injection
measure: visual acuity(Snellen chart)
timeFrame: Change from Baseline visual acuity at four weeks after injection
measure: visual acuity
timeFrame: Change from Baseline visual acuity at eight weeks after injection
measure: visual acuity(Snellen chart)
timeFrame: Change from Baseline visual acuity at 12weeks after injection
measure: visual acuity(Snellen chart)
timeFrame: Change from Baseline visual acuity at half year after injection
measure: visual acuity(Snellen chart)
timeFrame: Change from Baseline visual acuity at 1 year after injection
Secondary outcomes:
measure: macular central fovea thickness(OCT)
timeFrame: baseline
measure: macular central fovea thickness
timeFrame: Change from Baseline macular central fovea thickness at four weeks after injection
measure: macular central fovea thickness(OCT)
timeFrame: Change from Baseline macular central fovea thickness at eight weeks after injection
measure: macular central fovea thickness(OCT)
timeFrame: Change from Baseline macular central fovea thickness at 12 weeks after injection
measure: macular central fovea thickness(OCT)
timeFrame: Change from Baseline macular central fovea thickness at half year after injection
measure: macular central fovea thickness(OCT)
timeFrame: Change from Baseline macular central fovea thickness at 1 year after injection
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University Eye Hospital
state: Tianjin
Study officials:
References: