The risk of endophthalmitis following intravitreal triamcinolone injection in the DRCRnet and SCORE clinical trials

Am J Ophthalmol. 2007 Sep;144(3):454-6. doi: 10.1016/j.ajo.2007.04.011.

Abstract

Purpose: To report the incidence of endophthalmitis following intravitreal injection using a standardized injection procedure.

Design: Two randomized clinical trials.

Methods: Nonpreserved intravitreal triamcinolone acetonide in prefilled syringes (Allergan, Inc, Irvine, California, USA) was injected intravitreally in the Diabetic Retinopathy Clinical Research Network (DRCR net) and the Standard Care vs COrticosteroid for REtinal Vein Occlusion (SCORE) clinical trials. The standardized injection procedure did not include the use of topical antibiotics during the days prior to the injection.

Results: As of December 31, 2006, 1,378 intravitreal injections (538 eyes) have been administered in the Diabetic Retinopathy Clinical Research Network Diabetic Macular Edema trial and 631 injections (301 eyes) in Standard Care vs COrticosteroid for REtinal Vein Occlusion. There was one case of endophthalmitis in the 2,009 injections to date (0.05%, 95% confidence interval 0.001% to 0.277%).

Conclusion: A low rate of endophthalmitis is achievable using a standardized procedure for intravitreal injection without prescribing antibiotic prophylaxis on the days prior to the injection.

Trial registration: ClinicalTrials.gov NCT00105027 NCT00336323.

Publication types

  • Research Support, N.I.H., Extramural

MeSH terms

  • Administration, Topical
  • Anti-Infective Agents / administration & dosage
  • Clinical Trials as Topic
  • Endophthalmitis / chemically induced
  • Endophthalmitis / epidemiology*
  • Endophthalmitis / prevention & control
  • Fluoroquinolones / administration & dosage
  • Gatifloxacin
  • Glucocorticoids / administration & dosage*
  • Glucocorticoids / adverse effects
  • Humans
  • Incidence
  • Injections
  • Ophthalmic Solutions / administration & dosage
  • Risk Factors
  • Triamcinolone Acetonide / administration & dosage*
  • Triamcinolone Acetonide / adverse effects
  • Vitreous Body

Substances

  • Anti-Infective Agents
  • Fluoroquinolones
  • Glucocorticoids
  • Ophthalmic Solutions
  • Triamcinolone Acetonide
  • Gatifloxacin

Associated data

  • ClinicalTrials.gov/NCT00105027
  • ClinicalTrials.gov/NCT00336323