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

P

Poitiers University Hospital

Status and phase

Completed
Phase 4

Conditions

Type 3 Choroidal Neovascularization

Treatments

Drug: Aflibercept

Study type

Interventional

Funder types

Other

Identifiers

NCT02320474
ATTRACT (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

26 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

26 participants in 1 patient group

Aflibercept
Experimental group
Treatment:
Drug: Aflibercept

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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