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

Intravitreal Injection Clinical Trial

— ENIVAC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03635268
• Other study ID #: MARIET AOI 2017
• Status: Completed
• Start date: January 1, 2016
• Est. completion date: August 1, 2017

Study information

• Verified date: August 2018
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360000
• Est. completion date: August 1, 2017
• Est. primary completion date: December 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Endophthalmitis
• Intravitreal Injection

Intervention

Other:
• Data collection
Sociodemographic, medical and hospital, on ambulatory care consumption data.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of occurrence of endophthalmitis		Up to 28 days following an intravitreal injection