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

Type 3 Choroidal Neovascularization Clinical Trial

— ATTRACT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02320474
• Other study ID #: ATTRACT
• Status: Completed
• Phase: Phase 4
• Start date: November 25, 2014
• Est. completion date: November 2018

Study information

• Verified date: March 2019
• Source: Poitiers University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: November 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Choroidal Neovascularization
• Neovascularization, Pathologic
• Type 3 Choroidal Neovascularization

Intervention

Drug:
• Aflibercept

Locations

Country	Name	City	State
France	Poitiers University Hospital	Poitiers
France	Polyclinic of POITIERS	Poitiers

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change from baseline in Best Corrected Visual Acuity (BCVA)	Mean change from baseline in Best Corrected Visual Acuity (BCVA) as measured by ETDRS letter score at 4 meters	52 weeks