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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