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

Overview

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.

Full Title of Study: “Efficacy of Aflibercept (Eylea®) on Choroidal Neovascularization (Type 3)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 2018

Interventions

  • Drug: Aflibercept

Arms, Groups and Cohorts

  • Experimental: Aflibercept

Clinical Trial Outcome Measures

Primary Measures

  • Mean change from baseline in Best Corrected Visual Acuity (BCVA)
    • Time Frame: 52 weeks
    • Mean change from baseline in Best Corrected Visual Acuity (BCVA) as measured by ETDRS letter score at 4 meters

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Poitiers University Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Nicolas LEVEZIEL, MD, PhD, Principal Investigator, CHU Poitiers

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