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)

U

University Hospital Center (CHU) Dijon Bourgogne

Status

Completed

Conditions

Intravitreal Injection

Treatments

Other: Data collection

Study type

Observational

Funder types

Other

Identifiers

NCT03635268
MARIET AOI 2017

Details and patient eligibility

About

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.

Enrollment

360,000 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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