Clinical Trials Directory

Trials / Completed

CompletedNCT03635268

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
Phase
Study type
Observational
Enrollment
360,000 (actual)
Sponsor
Centre Hospitalier Universitaire Dijon · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERData collectionSociodemographic, medical and hospital, on ambulatory care consumption data.

Timeline

Start date
2016-01-01
Primary completion
2016-12-01
Completion
2017-08-01
First posted
2018-08-17
Last updated
2026-02-09

Source: ClinicalTrials.gov record NCT03635268. Inclusion in this directory is not an endorsement.