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

Completed

• Conditions: Intravitreal Injection

• Registration Number: NCT03635268
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-01
• Primary Completion: 2016-12-01
• Study Completion: 2017-08-01
• Status Verified: 2018-08
• Study First Submitted: 2018-08-14
• Study First Submitted QC: 2018-08-16
• Last Update Submitted: 2018-08-16
• Study First Posted: 2018-08-17
• Last Update Posted: 2018-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 360000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frequency of occurrence of endophthalmitis	Up to 28 days following an intravitreal injection