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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03635268

Acronym

ENIVAC

Enrollment

360000

Registered

2018-08-17

Start date

2016-01-01

Completion date

2017-08-01

Last updated

2026-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intravitreal Injection

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.

Interventions

OTHERData collection

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

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Frequency of occurrence of endophthalmitis	Up to 28 days following an intravitreal injection

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026