Efficacy of Aflibercept (Eylea®) on Type 3 choroidal neovascularization.

• Conditions: Retinal diseases (type 3 choroidal neovascularization); MedDRA version: 18.0Level: LLTClassification code 10060837Term: Choroidal neovascularizationSystem Organ Class: 100000004853; Therapeutic area: Body processes [G] - Ocular Physiological Phenomena [G14]

• Registration Number: EUCTR2014-001640-38-FR
• Lead Sponsor: CHU DE POITIERS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06-18
• Last Update Posted: 14 March 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

-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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>-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<br>;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 Outcome Measures

Name	Time	Method
Secondary end point(s): -Proportion of patients gaining 3 ETDRS lines or more at 24 weeks. <br>-Proportion of patients with stable visual acuity at 24 weeks (VA changes less than 3 ETDRS lines).<br>-Proportion of patients with significant visual acuity loss of 3 ETDRS lines or more at 24 weeks.<br>-Mean best-corrected visual acuity (BCVA) change from baseline to week 24.<br>-Anatomical outcomes: Subretinal fluid, intraretinal edema and intraretinal cysts and mean change in CRT from baseline to weeks 12, 24 and 52.<br>;Timepoint(s) of evaluation of this end point: weeks 12, 24 and 52