Status:
COMPLETED
Study Evaluating the Efficacy of Aflibercept for the Treatment of NVCI in Young Patients
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Idiopathic Choroidal Neovascularization
Eligibility:
All Genders
18-50 years
Phase:
PHASE2
Brief Summary
After myopia, the second etiology of choroidal neovascularization (CNV) in young adults (\<50 years old) is idiopathic choroidal neovascularization (ICNV) whose etiology remains unknown. This is a rar...
Eligibility Criteria
Inclusion
- 18 \< Age \< 50 years old
- Patient who give voluntary signed informed consent
- Patient affiliated with the French universal health care system 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
- 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
Key Trial Info
Start Date :
July 6 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 11 2019
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT02257502
Start Date
July 6 2015
End Date
July 11 2019
Last Update
August 8 2025
Active Locations (1)
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1
Hospices Civils de Lyon - Hôpital de la Croix-Rousse
Lyon, France, 69004