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

March 7, 2019 updated by: Poitiers University Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Poitiers, France, 86000
        • Poitiers University Hospital
      • Poitiers, France, 86000
        • Polyclinic of POITIERS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Aflibercept
Drug: Aflibercept

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Poitiers University Hospital

Investigators

  • Principal Investigator: Nicolas LEVEZIEL, MD, PhD, CHU Poitiers

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 25, 2014

Primary Completion (ACTUAL)

November 1, 2018

Study Completion (ACTUAL)

November 1, 2018

Study Registration Dates

First Submitted

December 10, 2014

First Submitted That Met QC Criteria

December 15, 2014

First Posted (ESTIMATE)

December 19, 2014

Study Record Updates

Last Update Posted (ACTUAL)

March 8, 2019

Last Update Submitted That Met QC Criteria

March 7, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ATTRACT (Other Identifier: Amicus Therapeutics)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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