Clincosm LogoSign in Get a demo

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

Sponsor
Centre Hospitalier Universitaire Dijon (Other)
Overall Status
Completed
CT.gov ID
NCT03635268
Collaborator
(none)
360,000
Enrollment
19
Actual Duration (Months)

Study Details

Study Description

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 Phase
  • Other: Data collection

Study Design

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 :
Jan 1, 2016
Actual Primary Completion Date :
Dec 1, 2016
Actual Study Completion Date :
Aug 1, 2017

Outcome Measures

Primary Outcome Measures

  1. Frequency of occurrence of endophthalmitis [Up to 28 days following an intravitreal injection]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Centre Hospitalier Universitaire Dijon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier:
NCT03635268
Other Study ID Numbers:
  • MARIET AOI 2017
First Posted:
Aug 17, 2018
Last Update Posted:
Aug 17, 2018
Last Verified:
Aug 1, 2018
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Endophthalmitis

Study Results

No Results Posted as of Aug 17, 2018