Endophthalmitis After Intravitreal Injection of Antiangiogenic Agents or Corticosteroids, a Cohort Study of the French Population of Patients Who Received Injections Over 9 Years
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 360,000
- Primary Endpoint
- Frequency of occurrence of endophthalmitis
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Frequency of occurrence of endophthalmitis
Time Frame: Up to 28 days following an intravitreal injection
Secondary Outcomes
No secondary outcomes reported