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)
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|ClinicalTrials.gov Identifier: NCT03635268|
Recruitment Status : Completed
First Posted : August 17, 2018
Last Update Posted : August 17, 2018
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.
|Condition or disease||Intervention/treatment|
|Intravitreal Injection||Other: Data collection|
|Study Type :||Observational|
|Actual Enrollment :||360000 participants|
|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|
|Actual Study Start Date :||January 1, 2016|
|Actual Primary Completion Date :||December 1, 2016|
|Actual Study Completion Date :||August 1, 2017|
- Other: Data collection
Sociodemographic, medical and hospital, on ambulatory care consumption data.
- Frequency of occurrence of endophthalmitis [ Time Frame: Up to 28 days following an intravitreal injection ]