Risk of endophthalmitis after intravitreal drug injection when topical antibiotics are not required: the diabetic retinopathy clinical research network laser-ranibizumab-triamcinolone clinical trials

Arch Ophthalmol. 2009 Dec;127(12):1581-3. doi: 10.1001/archophthalmol.2009.304.

Abstract

Objective: To report the incidence of endophthalmitis after intravitreal drug injection by means of a standardized procedure that does not require topical antibiotics, sterile gloves, or a sterile drape.

Methods: Intravitreal injections of preservative-free triamcinolone acetonide or ranibizumab were administered in 2 prospective randomized clinical trials performed by the Diabetic Retinopathy Clinical Research Network. The standardized procedure for these trials requires the use of a topical combination product of povidone-iodine, a sterile lid speculum, and topical anesthetic, but does not require the use of topical antibiotics before, on the day of, or after injection.

Results: As of February 23, 2009, a total of 3226 intravitreal injections of ranibizumab and 612 injections of preservative-free triamcinolone had been administered. Topical antibiotics were given on the day of injection in 361 (9.4%) of the 3838 cases, for several days after injection in 813 cases (21.2%), on the day of injection and after injection in 1388 cases (36.2%), and neither on the day of injection nor after injection in 1276 cases (33.3%). Three cases of culture-positive endophthalmitis occurred after ranibizumab injections (0.09%), and no cases occurred after triamcinolone injections. In all 3 cases of endophthalmitis, topical antibiotics were given for several days after the injection but not before injection.

Conclusions: The results suggest that a low rate of endophthalmitis can be achieved by means of a protocol that includes use of topical povidone-iodine, a sterile lid speculum, and topical anesthetic, but does not require topical antibiotics, sterile gloves, or a sterile drape. Trial Registration clinicaltrials.gov Identifiers: NCT00444600 and NCT00445003.

Publication types

  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Anesthetics, Local / administration & dosage
  • Angiogenesis Inhibitors / administration & dosage
  • Anti-Bacterial Agents / administration & dosage*
  • Antibodies, Monoclonal / administration & dosage*
  • Antibodies, Monoclonal, Humanized
  • Disinfection / methods
  • Endophthalmitis / epidemiology*
  • Endophthalmitis / microbiology
  • Endophthalmitis / prevention & control
  • Eye Infections, Bacterial / epidemiology*
  • Eye Infections, Bacterial / microbiology
  • Eye Infections, Bacterial / prevention & control
  • Glucocorticoids / administration & dosage
  • Humans
  • Incidence
  • Injections
  • Laser Coagulation*
  • Macular Degeneration / therapy
  • Methicillin-Resistant Staphylococcus aureus / isolation & purification
  • Povidone-Iodine / administration & dosage
  • Prospective Studies
  • Ranibizumab
  • Risk Factors
  • Staphylococcal Infections / epidemiology
  • Staphylococcal Infections / microbiology
  • Staphylococcal Infections / prevention & control
  • Streptococcal Infections / epidemiology
  • Streptococcal Infections / microbiology
  • Streptococcal Infections / prevention & control
  • Triamcinolone Acetonide / administration & dosage*
  • Vascular Endothelial Growth Factor A / antagonists & inhibitors
  • Viridans Streptococci / isolation & purification
  • Vitreous Body

Substances

  • Anesthetics, Local
  • Angiogenesis Inhibitors
  • Anti-Bacterial Agents
  • Antibodies, Monoclonal
  • Antibodies, Monoclonal, Humanized
  • Glucocorticoids
  • Vascular Endothelial Growth Factor A
  • Povidone-Iodine
  • Triamcinolone Acetonide
  • Ranibizumab

Associated data

  • ClinicalTrials.gov/NCT00444600
  • ClinicalTrials.gov/NCT00445003