Status:
COMPLETED
CNV in AMD Analyzed by OCT Angiography Under IntravitreaL Eylea (COCTAEyl)
Lead Sponsor:
Centre Hospitalier Intercommunal Creteil
Collaborating Sponsors:
Bayer
Conditions:
AMD
Exudative Macular Degeneration
Eligibility:
All Genders
55+ years
Brief Summary
The main objective of this study is to analyze a new noninvasive imaging examination, OCT angiography, in the evaluation of neovascular remodeling and early signs of recurrence of wet AMD undergoing t...
Eligibility Criteria
Inclusion
- Naïve patients
- Type 1 or type 2 Choroidal NeoVascularization (CNV)
- Age ≥ 55 years
- Presence of subfoveal CNV secondary to Age-related Macular Degeneration (AMD)
- At the time of inclusion, multimodal imaging should reveal exudative features
- Exudative AMD diagnosis established between 1 and 7 days before inclusion
- Monitored monthly
- Loading phase then bimonthly retreatment.
- Signed Informed Consent.
- Patient covered by the French Health Insurance
Exclusion
- Polypoidal choroidal vasculopathy
- Type 3 neovascularization
- Choroidal neovascularization attributable to causes other than AMD
- Macular hematoma
- Pigment epithelial detachment higher than 150µm
- Fibrosis \> 50% lesion on fundus color photography, fibroglial scar
- Media opacity annoying acquisition
- Retinal vascular occlusion
- Diabetic retinopathy
- Adult-onset foveomacular vitelliform dystrophy and other pattern dystrophies,
- Refractive error \>-6D
- Active intraocular inflammation in the study eye
- Patient who does not meet the local indication criteria for Eylea® treatment. Contraindications listed in the SmPCs must be taken into account
- Patient taking part in an interventional study at the time of enrolment.
- Any history of allergy to the antiseptic used during preparation of the eye for the IVT injection in the investigational site (e.g. povidone iodine or chlorhexidine).
- Pregnant and lactating women
- Stroke and/or myocardial infarction 3 months before inclusion
Key Trial Info
Start Date :
April 4 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 15 2021
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT03803631
Start Date
April 4 2018
End Date
November 15 2021
Last Update
September 2 2025
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Hôpital Pellegrin, CHU de Bordeaux
Bordeaux, France, 33000
2
CHI de Créteil
Créteil, France, 94000
3
Hôpital La Croix Rousse
Lyon, France, 69004
4
Hôpital Lariboisière, APHP
Paris, France, 75010