Efficacy of Aflibercept (Eylea®) on Choroidal Neovascularization (Type 3)

Phase 4

Completed

• Conditions: Type 3 Choroidal Neovascularization
• Interventions: Drug: Aflibercept

• Registration Number: NCT02320474
• Lead Sponsor: Poitiers University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11-25
• Study First Submitted: 2014-12-10
• Study First Submitted QC: 2014-12-15
• Study First Posted: 2014-12-19
• Primary Completion: 2018-11
• Study Completion: 2018-11
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-07
• Last Update Posted: 2019-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Aflibercept	Aflibercept	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Poitiers University Hospital; 🇫🇷 Poitiers, France

Polyclinic of POITIERS; 🇫🇷 Poitiers, France