Retinal diseases (type 3 choroidal neovascularization) MedDRA version: 18.0 Level: LLT Classification code 10060837 Term: Choroidal neovascularization System Organ Class: 100000004853
Conditions
Interventions
Trade Name: Aflibercept (EYLEA ®) 40mg/ml
Product Name: aflibercept
Pharmaceutical Form: Solution for injection
Sponsors
CHU DE POITIERS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Males or females aged more than 50 years -Patients with type 3 choroidal neovascularization assessed on FA, ICG and OCT oThe type 3 CNV will be defined by following chacteristics on ICG: early hyperfluorescence spot at the end of a branching retinal vessel in the macular area frequently associated with punctiform retinal hemorrhage and hot spot on late frames sometimes located in an area of hypofluorescence due to pigment epithelium detachment. oThe type 3 CNV will be defined by following chacteristics on OCT: Effraction of the RPE layer toward the neurosensory retina, associated with exudation within or under the retina. This typical lesion will be observed when OCT scans located on hot spots. -Best Corrected Visual Acuity at inclusion between 24 and 78 letters (ETDRS letter score) in the study eye (approximately between 20/320 and 20/32 Snellen equivalent) -Media clarity, pupillary dilation and patient cooperation sufficient to allow fundus photographs of adequate quality -Ability to read, understand the study procedures -Given written informed consent allowing participation to this study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 4 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 22
Exclusion criteria
Exclusion criteria: -Any contraindications as reported in the labelling of Eylea®: Ocular or periocular infection, Active intraocular inflammation or Hypersensitivity in the study eye -Any previous history of intravitreal injections in the study eye for exudative AMD in the study eye -Any secondary chorioretinal anastomosis due to retinal scar or fibrosis in the study eye -Any history of vitrectomy in the study eye -Media opacities preventing accurate imaging of the retina (cataract) in the study eye -Any other retinal disorder possibly associated with type 3 CNV (epiretinal membrane, macular hole) in the study eye -Intellectual deficiency -Any active infectious disease -Patients with a significant medical condition which may interfere with the evaluation of safety or efficacy of the study compound (e.g., myocardial infarction, unstable angina pectoris within 3 months prior to study inclusion, severe renal failure or patients with renal dialysis / renal transplant). -Confirmed intraocular pressure =25 mmHg or non-stable glaucoma in the study eye
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of IVT administration of VEGF Trap-Eye in subjects with type 3 choroidal neovascular for a period of up to 52 weeks. ;Secondary Objective: - To assess the efficacy of IVT administration of VEGF Trap-Eye in subjects with type 3 choroidal neovascular for a period of up to 24 weeks. - To evaluate the following anatomical changes :subretinal fluid, intraretinal edema and intraretinal cysts and mean change in CRT from baseline to Week 12, 24 and 52 ;Primary end point(s): Mean change from baseline in Best Corrected Visual Acuity (BCVA) as measured by ETDRS letter score at 4 meters to 52 weeks;Timepoint(s) of evaluation of this end point: 52 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Proportion of patients gaining 3 ETDRS lines or more at 24 weeks. -Proportion of patients with stable visual acuity at 24 weeks (VA changes less than 3 ETDRS lines). -Proportion of patients with significant visual acuity loss of 3 ETDRS lines or more at 24 weeks. -Mean best-corrected visual acuity (BCVA) change from baseline to week 24. -Anatomical outcomes: Subretinal fluid, intraretinal edema and intraretinal cysts and mean change in CRT from baseline to weeks 12, 24 and 52. ;Timepoint(s) of evaluation of this end point: weeks 12, 24 and 52 | — |
Countries
France
Contacts
Public ContactFANNY ABRIAT
CHU DE POITIERS
Outcome results
None listed