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Endophthalmitis After Intravitreal Injection of Antiangiogenic Agents or Corticosteroids, a Cohort Study of the French Population of Patients Who Received Injections Over 9 Years (ENIVAC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03635268
Recruitment Status : Completed
First Posted : August 17, 2018
Last Update Posted : August 17, 2018
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

Brief Summary:

Intravitreal injections (IVI) of antiangiogenic agents (AA) have revolutionized the management of age-related macular degeneration (AMD) and diabetic macular edema (DME) in particular. Approximately 600,000 AA IVIs are performed each year in France.

Corticosteroid IVIs are an alternative in the treatment of macular edema when it is diabetic or related to venous occlusion, but also due to inflammation.

Endophthalmitis is one of the most feared complications after IVI because of its poor prognosis, despite its low incidence (values found in the literature between 0.01% and 0.08%). IVI practices have evolved over the years based on the recommendations of specialized organizations, with the current recommendation not to use antibiotic prophylaxis.

The purpose of this study is to study the effect of intravitreal injections of anti-angiogenic agents and corticosteroids on the occurrence of endophthalmitis within 28 days following an injection.

Condition or disease Intervention/treatment
Intravitreal Injection Other: Data collection

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Study Type : Observational
Actual Enrollment : 360000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Endophthalmitis After Intravitreal Injection of Antiangiogenic Agents or Corticosteroids, a Cohort Study of the French Population of Patients Who Received Injections Over 9 Years
Actual Study Start Date : January 1, 2016
Actual Primary Completion Date : December 1, 2016
Actual Study Completion Date : August 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids

Intervention Details:
  • Other: Data collection
    Sociodemographic, medical and hospital, on ambulatory care consumption data.

Primary Outcome Measures :
  1. Frequency of occurrence of endophthalmitis [ Time Frame: Up to 28 days following an intravitreal injection ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient who has had an intravitreal injection to deliver an anti-angiogenic agent or a corticosteroid

Inclusion Criteria:

  • adult patients within the French population who had an intravitreal injection, identified by CCAM coding BGLB001
  • associated with the delivery of an anti-angiogenic agent or a corticosteroid, identified by the corresponding CIP code
  • between February 2007 and November 2015

Exclusion Criteria:

  • intraocular surgery less than 42 days before the first injection, identified by the CCAM procedure
  • risk factors for endogenous endophthalmitis identified in the 42 days preceding an IVI identified by the ICD10 code
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Responsible Party: Centre Hospitalier Universitaire Dijon Identifier: NCT03635268    
Other Study ID Numbers: MARIET AOI 2017
First Posted: August 17, 2018    Key Record Dates
Last Update Posted: August 17, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Eye Infections
Eye Diseases