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OpenTrials
Completed

NCT Number: NCT02320474

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

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.

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Key information

Conditions

Type 3 Choroidal Neovascularization

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Poitiers University Hospital, Poitiers, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

aflibercept

Drug

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Acronym: ATTRACT

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Dec 19, 2014
Registry last updated
Mar 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.