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

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.

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Key information

Conditions

Intravitreal Injection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Data Collection

Other

Sociodemographic, medical and hospital, on ambulatory care consumption data.

Primary outcomes

Frequency of occurrence of endophthalmitis

Time frame: Up to 28 days following an intravitreal injection

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Acronym: ENIVAC

Important dates

Study start: 2016
Primary completion: 2016
Study completion: 2017
First posted: Aug 17, 2018
Registry last updated: Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed