Clinical trial NCT01181713: Change in Ocular Flora Resistance From Repeated Topical Antibiotic Use
Official title: Antibiotic Resistance of Ocular Surface Flora After Continued Use of Topical Antibiotics Post Intravitreal Injections
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Increased Drug Resistance
Infection Resistant to Quinolones and Fluoroquinolones
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: Novartis
First posted: 2010-08-13
Enrollment: 200
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient recruitment would be from the Sunnybrook Health and Sciences Centre Department of Ophthalmology

Brief summary: The purpose of this study is to determine if antibiotic resistance of the ocular surface flora to the 4th generation fluoroquinolones will increase after repeated use of topical antibiotics for three days post intravitreal injection.

Detailed description: Treatment with intravitreal (IVT) injections has increased during the last several years as evidence has accumulated demonstrating the efficacy of anti-vascular endothelial growth factor agents in the treatment of neovascular age-related macular degeneration (AMD) and various retinal vascular diseases.

Although IVT injections are generally safe, infectious endophthalmitis is a rare but devastating complication, and the risk of morbidity and vision loss from endophthalmitis is high. The objective is to examine the change in antibiotic resistance of ocular surface flora with repeated prophylactic use of antibiotics after IVT injection for AMD.

Yin, V. T., Weisbrod, D. J., Eng, K. T., Schwartz, C., Kohly, R., Mandelcorn, E., Lam, W., Daneman, N., Simor, A., \& Kertes, P. J. (2013). Antibiotic resistance of ocular surface flora with repeated use of a topical antibiotic after intravitreal injection. JAMA ophthalmology, 131(4), 456-461.

Eligibility criteria: Inclusion Criteria:

* patients scheduled for intravitreal injection for neovascular age-related macular degeneration (ARMD)
* 65 years or older
* able to provide informed consent.

Exclusion Criteria:

* diagnosed with an active ocular, periocular or systemic infection
* previously received treatment with an intravitreal injection
* previously treated with antibiotics in the past three months
* unable to attend the scheduled follow-up appointments or to complete treatment for any reason

Primary outcomes:
measure: ocular flora resistance to 4th generation fluoroquinolone
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health and Sciences Centre
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Peter Kertes, MD, FRCSC
role: STUDY_CHAIR
affiliation: University of Toronto
name: Vivian T Yin, MD
role: STUDY_DIRECTOR
affiliation: Sunnybrook Health Sciences Centre
name: Daniel Weisbrod, MD, FRCSC
role: STUDY_DIRECTOR
References:
citation: Yin VT, Weisbrod DJ, Eng KT, Schwartz C, Kohly R, Mandelcorn E, Lam WC, Daneman N, Simor A, Kertes PJ. Antibiotic resistance of ocular surface flora with repeated use of a topical antibiotic after intravitreal injection. JAMA Ophthalmol. 2013 Apr;131(4):456-61. doi: 10.1001/jamaophthalmol.2013.2379.