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Completed

NCT Number: NCT02246829

Assessment of Early Changes in SD-OCT After Initiation of a Treatment by Intravitreal Aflibercept (EYLEA®)START

Aflibercept (EYLEA®) induces a rapid reduction in central retinal thickness (CRT) for patients suffering from neovascular age-related-macular degeneration.1 This early dramatic reduction in CRT is already observed through week 4. Therefore it might be not necessary to consistently perform each of the three monthly consecutive intravitreal injections of the so-called loading phase.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Service d'ophtalmologie Hôpital Henri Mondor 40, avenue de Verdun, Créteil, France

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About this study

The aim of this study is to assess whether the retina of some patients has dried up after the first or second intravitreal injection of Aflibercept (EYLEA®) 2mg and in that event, to determine the proportion of these patients The analysis of the characteristics could help identify a morphotype that would predict whether and when the retina will dry up within the first 3 months of treatment. For some patients having an early drying-up, the third monthly injection might be not necessary 50 naïve patients will be included and will receive a monthly injection over 12 weeks with a biweekly follow-up. Morphological and functional characteristics will be recorded at each visit and will be analyzed. The rate of patients with dry SD-OCT will be assessed.

The study includes 7 visits. The visits are scheduled on an every 2-week basis from baseline to Week 12. V1 (baseline), V3 and V5, the patient will be injected with Aflibercept (EYLEA®) 2mg. In the other visits, the visual acuity test, Fundus photography, SD-OCT, and/or Fluorescein Angiography are performed

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Men and women ≥ 50 years of age
  • Active primary subfoveal choroidal neovascularization (CNV) lesions secondary to AMD including juxtafoveal lesions that affects the fovea as evidenced by FA in the study eye
  • Signed Informed Consent
  • Willing, committed, and able to return for ALL clinic visits and complete all study-related procedures.

Exclusion criteria

  • Prior treatment with anti-VEGF therapy in the study eye
  • Active or suspected ocular or periocular infection.
  • Active severe intraocular inflammation

Treatment and study plan

intravitreal injection

Procedure

2 mg intravitreal Aflibercept initiated with one injection every 4 weeks for three consecutive doses (loading dose) The duration of the follow-up is 12 weeks. This means 3 injections per patient should be given over the study period

Primary outcomes

  1. Occurence of a Dry SD-OCT 12-week after initiation of a treatment by Aflibercept (EYLEA®) 2mg

    Time frame: 12-week after initiation of a treatment by Aflibercept (EYLEA®) 2mg

Secondary outcomes

  1. Time to get a dry SD-OCT after initiation of a treatment by Aflibercept

    Time frame: Every 2 weeks from treatment initiation (inclusion) to week 12

  2. Evolution of morphological and visual modification under Aflibercept (EYLEA®)

    Time frame: Every 2 weeks from treatment initiation (inclusion) to week 12

  3. Occurence of pigment epithelial detachment

    Time frame: Every 2 weeks from treatment initiation (inclusion) to week 12

  4. Evolution of retinal hemorrhage if any

    Time frame: Every 2 weeks from treatment initiation (inclusion) to week 12

  5. Evolution in the atrophic lesions

    Time frame: Every 2 weeks from treatment initiation (inclusion) to week 12

  6. Occurence the central Retinal Thickness

    Time frame: Every 2 weeks from treatment initiation (inclusion) to week 12

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study title

Assessment of Early Changes in SD-OCT After Initiation of a Treatment by Intravitreal Aflibercept (EYLEA®) (2mg) Over a 12-week Period for Patients Suffering From Neovascular Age-related Macular Degeneration (AMD) French SD OCT in wAMD

Acronym: START

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Sep 23, 2014
Registry last updated
Nov 21, 2016

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.