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

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ClinicalTrials.gov Identifier: NCT02246829
Recruitment Status : Completed
First Posted : September 23, 2014
Last Update Posted : November 21, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Neovascular Age-related Macular Degeneration of All Subtypes Procedure: Intravitreal injection Phase 4

Detailed Description:

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


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : September 2014
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Aflibercept 2mg Intravitreal injection
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
Procedure: Intravitreal injection
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 Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02246829


Locations
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France
Service d'ophtalmologie Hôpital Henri Mondor 40, avenue de Verdun
Creteil, France, 94000
Service Ophtalmologie CHU DIJON 14 rue Gaffarel BP 77908
Dijon, France, 21079
Service d'Ophtalmologie Hôpital de la croix rousse
Lyon, France, 69317
Cabinet d'ophtalmologie 1 rue Pougin de la Maisonneuve
Montargis, France, 45200
Sce Ophtalmologie CHU Nantes 1 place Alexis Ricordeau
Nantes, France, 44093
Centre ophtalmique d'imagerie et de laser (CIL) 11 rue Antoine Bourdelle
Paris, France, 75011
Sce du Pr SAHEL Fondation ROTHSCHILD 25 rue Manin
Paris, France, 75019
Sce Ophtalmologie Hôpital Lariboisière 2 rue Ambroise Paré
Paris, France, 75475
Service Opthalmo 2 Clinique Mathilde 4 rue de Lessard
Rouen, France, 76100
Centre Ophtalmologie Transparence 30 Boulevard Heurteloup
Tours, France, 37000
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
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Principal Investigator: Jean-François KOROBELNIK, Professor University Hospital Bordeaux, France
Study Chair: Geneviève CHENE, MDPhD University Hospital Bordeaux, France

Publications:

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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT02246829     History of Changes
Other Study ID Numbers: CHUBX 2013/18
First Posted: September 23, 2014    Key Record Dates
Last Update Posted: November 21, 2016
Last Verified: November 2016
Keywords provided by University Hospital, Bordeaux:
wet AMD, SD-OCT, intravitreal injection, central retinal thickness,
Additional relevant MeSH terms:
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Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases