Type 3 Choroidal Neovascularization
Conditions
Brief summary
This is a one-year pilot, interventional, prospective, single arm, non-randomized, multicentric (3 centers) controlled study that aims to evaluate the response of type 3 choroidal neovascularization to treatment by Aflibercept following a classic protocol.
Interventions
DRUGAflibercept
Sponsors
Poitiers University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Males or females aged more than 50 years * Patients with type 3 choroidal neovascularization assessed on FA, ICG and OCT * Exudation on SD-OCT scans defined by intraretinal cysts or subretinal fluid. * Best Corrected Visual Acuity at inclusion between 24 and 78 letters (ETDRS) * Media clarity, pupillary dilation and patient cooperation sufficient to allow fundus photographs of adequate quality
Exclusion criteria
* Any contraindications as reported in the labelling of Aflibercept (Eylea®): Ocular or periocular infection, Active intraocular inflammation or Hypersensitivity. * Any previous history of intravitreal injections in the study eye for exudative AMD * Any secondary chorioretinal anastomosis due to retinal scar or fibrosis * Any history of vitrectomy * Media opacities preventing accurate imaging of the retina (cataract) * Any other retinal disorder possibly associated with type 3 CNV (epiretinal membrane, macular hole) * Confirmed intraocular pressure ≥25 mmHg or non-stable glaucoma.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean change from baseline in Best Corrected Visual Acuity (BCVA) | 52 weeks | Mean change from baseline in Best Corrected Visual Acuity (BCVA) as measured by ETDRS letter score at 4 meters |
Countries
France
Outcome results
None listed