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)

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.

Study Overview

• Status: Completed
• Conditions: Intravitreal Injection
• Intervention / Treatment: Other: Data collection

• Study Type: Observational
• Enrollment (Actual): 360000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• 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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Dijon

Publications and helpful links

General Publications

• Baudin F, Benzenine E, Mariet AS, Bron AM, Daien V, Korobelnik JF, Quantin C, Creuzot-Garcher C. Association of Acute Endophthalmitis With Intravitreal Injections of Corticosteroids or Anti-Vascular Growth Factor Agents in a Nationwide Study in France. JAMA Ophthalmol. 2018 Dec 1;136(12):1352-1358. doi: 10.1001/jamaophthalmol.2018.3939.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: August 14, 2018
• First Submitted That Met QC Criteria: August 16, 2018
• First Posted (Actual): August 17, 2018

Study Record Updates

• Last Update Posted (Actual): February 9, 2026
• Last Update Submitted That Met QC Criteria: February 5, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Eye Diseases; Eye Infections; Endophthalmitis; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Data Collection
• Other Study ID Numbers: MARIET AOI 2017

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No