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

November 18, 2016 updated by: University Hospital, Bordeaux

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

50

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
      • Creteil, France, 94000
        • Service d'ophtalmologie Hôpital Henri Mondor 40, avenue de Verdun
      • Dijon, France, 21079
        • Service Ophtalmologie CHU DIJON 14 rue Gaffarel BP 77908
      • Lyon, France, 69317
        • Service d'Ophtalmologie Hôpital de la croix rousse
      • Montargis, France, 45200
        • Cabinet d'ophtalmologie 1 rue Pougin de la Maisonneuve
      • Nantes, France, 44093
        • Sce Ophtalmologie CHU Nantes 1 place Alexis Ricordeau
      • Paris, France, 75011
        • Centre ophtalmique d'imagerie et de laser (CIL) 11 rue Antoine Bourdelle
      • Paris, France, 75019
        • Sce du Pr SAHEL Fondation ROTHSCHILD 25 rue Manin
      • Paris, France, 75475
        • Sce Ophtalmologie Hôpital Lariboisière 2 rue Ambroise Paré
      • Rouen, France, 76100
        • Service Opthalmo 2 Clinique Mathilde 4 rue de Lessard
      • Tours, France, 37000
        • Centre Ophtalmologie Transparence 30 Boulevard Heurteloup

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:

  • 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

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
12-week after initiation of a treatment by Aflibercept (EYLEA®) 2mg

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Every 2 weeks from treatment initiation (inclusion) to week 12
Evolution of morphological and visual modification under Aflibercept (EYLEA®)
Time Frame: Every 2 weeks from treatment initiation (inclusion) to week 12
Every 2 weeks from treatment initiation (inclusion) to week 12
Occurence of pigment epithelial detachment
Time Frame: Every 2 weeks from treatment initiation (inclusion) to week 12
Every 2 weeks from treatment initiation (inclusion) to week 12
Evolution of retinal hemorrhage if any
Time Frame: Every 2 weeks from treatment initiation (inclusion) to week 12
Every 2 weeks from treatment initiation (inclusion) to week 12
Evolution in the atrophic lesions
Time Frame: Every 2 weeks from treatment initiation (inclusion) to week 12
Every 2 weeks from treatment initiation (inclusion) to week 12
Occurence the central Retinal Thickness
Time Frame: Every 2 weeks from treatment initiation (inclusion) to week 12
Every 2 weeks from treatment initiation (inclusion) to week 12

Collaborators and Investigators

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

Sponsor

University Hospital, Bordeaux

Investigators

  • Principal Investigator: Jean-François KOROBELNIK, Professor, University Hospital Bordeaux, France
  • Study Chair: Geneviève CHENE, MDPhD, University Hospital Bordeaux, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

September 1, 2014

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

September 11, 2014

First Submitted That Met QC Criteria

September 18, 2014

First Posted (Estimate)

September 23, 2014

Study Record Updates

Last Update Posted (Estimate)

November 21, 2016

Last Update Submitted That Met QC Criteria

November 18, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2013/18

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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